Site Management and Control Schwarz Pharma Ltd. Pharma Ltd ...

Site Management and Control

Schwarz Pharma Ltd. Pharma Ltd. Revised IPCL Application

Issue No 2

53836-003

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Attachment C.1 Site Management and Control Schwarz Pharma Revised IPCL Application

CONTENTS

Section Page No

1.

2.

3.

a 4.

5.

6.

7.

8.

INTRODUCTION TO MANAGEMENT SYSTEMS .......................................................... 1

MANAGEMENT ORGANISATIONAL STRUCTURE INCLUDING ENVIRONMENTAL MANAGEMENT RESPONSIBILITY LEVELS ................................. 1

MANAGEMENT OF TREATMENT AND ABATEMENT SYSTEMS ............................... 2

CALIBRATION AND MAINTENANCE SYSTEMS .......................................................... 4

WASTE CONTROL SYSTEMS ........................................................................................ 4

GENERAL OUTLINE OF QUALITY CONTROL SYSTEM .............................................. 6

ENVIRONMENTAL MANAGEMENT PROGRAMME ...................................................... 7

ONGOING ASSESSMENT OF ENVIRONMENTAL PERFORMANCE .......................... 9

a

Appendix C.l.l IS0 14001

Appendix C. 1.2 Quality Policy

Appendix Cl .3 EHS Manual

Appendix C.1.4 List of Environmental Management Standard Operation Procedures

Appendix C.l.5 Environmental, Health and Safety Policy Statement

Appendix C.1.6 Duties under Responsible Care

Appendix C.1.7 Scrubber Abatement Systems Standard Operation Procedures

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Attachment C.q Site anagement and Control SckwatzPharma We ed IPCL Application

2.

INTRODUCTION TO MANAGEMENT SYSTEMS

Schwatz Pharma Ltd. is owned by Schwarz Pharma AG, Monheim, Germany. Schwarz Pharma Ltd. has a structured management approach to the operation of the business in terms of product quality, process control, environment, safety, training and analytical capability.

The pharmaceutical plant is a licensed pharmaceutical facility, operating under FDA approval and cGMP conditions. Training of personnel is a key function in the successful operation of the plant and the company is certified to the Fas Excellence ThrougIJ People Standard.

Safety and environmental quality management systems are audited on an ongoing basis by a combination of internal audit teams and National Standards Authority of Ireland (NSAI) external audits. The quality management system is certified to IS0 9001 by NSAI and the environmental management system is certified to IS0 14001, also by NSAI. Appendix C.1 .I contains a copy of the IS0 14001 accreditation certificate. In addition, the plant is also regulated under the EU Seveso Directive through the European Communities (Control of Major Accident Hazards Involving Dangerous Substances) Regulations 2000.

MANAGEMENT ORGANISATIONAL STRUCTURE INCLUDING ENVIRONMENTAL MANAGEMENT RESPONSIBILITY LEVELS

The management structure at Schwarz Pharma Ltd. is illustrated in Figure C. 1.1 below. Schwarz Pharma Ltd. operates a relatively flat management structure with a strong emphasis on team working. This structure was implemented in early 2004 and focuses more resources solely on environmental management.

The Environment and Safety Manager and environmental officers are dedicated to environmental projects and safety issues. The Environment and Safety Manager has responsibility for the day-to-day operation of the site environmental management system, together with implementation of a number of specific compliance related programmes under the EMP. The Environment and Safety Manager is supported by three Environmental Officers responsible for monitoring, measurement, waste management and licensing issues.

Weekly management/technical meetings are held where environmental matters are discussed and reported as the need arises.

The post of Environment and Safety Manager requires either a diploma or degree in a relevant subject and appropriate experience. The current manager holds a BSc in environmental chemistry. Environmental Officers are required to either hold a certificate or other qualification in a relevant subject or have over six year’s relevant experience. Two of the current environmental officers holds a BSc in industrial chemistry while the third has over twenty-five years experience of the Schwarz Pharma Ltd. facility, twelve

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Attachment C.ll Site Schwarz Pharma We

gement and Control lPCL Application

years of which have been in the environmental management of the facility. All staff receives an environmental induction, and depending on requirements, external and internal training courses are given as needs arise.

The procedures for the management of treatment and abatement systems are laid out in the environment, health and safety management system, as supplemented by the relevant standard operating procedures.

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attachment c anagement And Control Schwarz Pharma Revised PCL Application

3. MANAGEMENT OF TREATMENT AND ABATEMENT SYSTEMS

The responsibility for the operation and control of treatment and abatement systems on site is that of the Environment and Safety Manager, reporting to the Head of QA and Support Services. The Environment and Safety Manager is supported in this role by the Environmental Officers.

Procedures are in place for the operation and control of the recently introduced scrubbers in the BPC and the nitration plant and are included in Appendix C. 1.7.

4.

5.

CALIBRATION AND MAINTENANCE SYSTEMS

Schwarz Pharma Ltd. has established standard procedures for the calibration and maintenance of environmental abatement and treatment equipment. These procedures are summarised below:

o 602.049 Calibration of Air Sampling Pumps

l 602.078 Procedure for Calibrating Laboratory Balance

l 602.079 Calibration of DR/2000 Spectrophotometer

l 602.080 Calibration of Gallenkamp Vacuum Oven

l 602.081 Calibration of Sound Level Meter and Acoustic Calibrator

l 602.082 Use and Calibration of Digital Water Bat

o 602.086 D.O. Meter Calibration and Determination

l 610.016 Calibration of Environmental Measuring and Monitoring Equipment

l 630.004 Calibration of Air Flows Through Laboratory Fume Cupboards

m 301.032 Instrument Calibration

l 301.161 pH Sensor Calibration

l 303.005 Calibration of Dissolved Oxygen Meter and Probe

WASTE CONTROL SYSTEMS

Schwarz Pharma Ltd. operates a strict waste management and control system, which is defined by documented site-specific standard operating procedures, which are reviewed and updated regularly to reflect up-to-date operations on-site.

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Attachment c anagemefnt and Control Schwarz Phar Revised IPCL Application

Waste production control is carried out by the measurement of yield in accordance with good manufacturing practice requirements and waste is minimised where possible. Wastes are contained in suitable containers and evaluated for reprocessing or recovery.

Relevant standard operating procedures for waste management are summarised below:

l 607.003 Transportation of Hazardous Goods t

Applicable to transportation of hazardous goods in general, this procedure defines the procedure and responsibilities for the classification, packaging and labelling of hazardous goods in addition to the preparation of appropriate documentation for transportation.

l 605.002 Waste Disposal Contractor Control

This procedure sets out the process by which waste contractors are approved for use by Schwarz Pharma Ltd.. It includes provision for ensuring that waste contractors are appropriately licensed or permitted and ensuring that waste is disposed of only by contractors approved by the Environmental Protection Agency.

l 605.044 Hazardous Waste Disposal

This procedure provides guidelines to ensure that hazardous chemical wastes arising directly from on-site processes are disposed of in accordance with company requirements, IPC licence requirements and the transport of dangerous goods regulations. It includes a description of waste record keeping and summarises the waste documentation requirements.

0 605,050 Preparation of Drummed Waste for Shipment

This procedure outlines the process for initiating the shipment of drummed waste, the responsibilities of various personnel in the preparation of the waste for shipment, the procedure for sealing and labelling of drums and responsibilities in loading of trucks.

. 605.051 Preparation of Bulk Waste for Shipment

This procedure outlines the procedure for initiating the shipment of bulk waste, the responsibilities of various personnel in the preparation of the waste for shipment and sampling and analysis of the waste shipment. In addition, requirements for record keeping are laid out.

l 605.062 Non-Process Waste Collection

This procedure outlines the process for arranging for the collection of non-process waste from Schwarz Pharma Ltd. These wastes include general waste, scrap metal, waste oil, degreaser solvent, glass, aluminium cans, fluorescent light tubes, canteen oil, timber waste, office hazardous waste, paper and cardboard.

In addition to the procedures described above, there are procedures for waste management within warehouse and production.

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nagement and Control Revised lPCL Application

6.

It is noted that there is an environmental project underway to minimise the volume of hazardous and non-hazardous waste requiring disposal. This is a five-year project, due to be completed in Q4 2008. On an annual basis, an internal hazardous waste audit is carried out. Disposal volumes, disposal types and the waste arising from the various processes are studied. Similarly, non-hazardous waste generation in terms of both types and volumes is reviewed annually. Waste minimisation programmes for hazardous and non-hazardous wastes are developed based on the results of these studies and audits, and these programmes are reviewed on an annual basis.

GENERAL OUTLINE OF QUALITY CONTROL SYSTEM

Schwarz Pharma Ltd. is committed to establishing and maintaining a quality management system, which meets the requirements of all applicable international guidelines and standards for the manufacture of bulk and finished pharmaceuticals. The company promotes continuous quality improvement in all of its products, processes and operations. Schwarz Pharma Ltd. has implemented a quality management system, which is certified to IS0 9001:2000 by NSAI, who carry out regular quality audits. The quality management system also meets the requirements of the FDA CFR Title 21 Parts 210, 211 and II, the EU cGMP requirements and other applicable guidelines and standards for the manufacture of bulk and finished pharmaceuticals. In addition, quality management at Schwarz Pharma Ltd. complies with the Schwarz Pharma Ltd. corporate pharmaceutical manual.

The quality system is built around three key principles:

l Resource management;

l Product realisation; and

. Measurement, analysis and improvement.

The quality system ensures that Schwarz Pharma Ltd.:

l Provides appropriate facilities, materials, equipment and trained personnel;

l Provides sufficient resources to monitor and update the quality system and

l Understands fully customer requirements and meets or exceeds those requirements.

The quality system is documented through the quality manual, standard operating procedures, and work instructions and specifications. The management at Schwarz Pharma Ltd. reviews the complete quality, system at an annual review meeting and objectives for the following year are set at this meeting. In addition, quality objectives are regularly monitored at management technical meetings with a view to continual improvement.


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Attachment @ nagmwmt and Control Schwarz Phar Revised PCL Application

Schwarz Pharma Ltd. strives for a “Right First Time” objective and believes that each individual employee has a vitally important contribution to make in the quality performance of the company. All employees are directly responsible and accountable for the quality of their own work and are invited to actively participate in the identification and solving of all incidents that may have a bearing of product quality.

The Head of QA and Support Services is responsible for maintaining an appropriate quality system and ensuring compliance to quality guidelines and standards. The management of the quality system incorporates areas such as document control, quality audits, change control, customer complaints and non-forming products. The Head of QA and Support Services is also responsible for providing adequate training facilities, coordination of training activities and documentation of training programmes.

The QA Specialist, who assists the Head of QA and Support Services, is supported by the QA Officer. The QA Specialist is responsible for the inspection; testing and keeping of associated documentation related to raw materials, finished products and packaging materials. In addition, the QA Specialist is responsible for the provision and update of material specifications and test procedures, maintenance and calibration of inspection and test equipment and the control of associated documentation. The QA Specialist is also responsible for the safe and secure warehousing of all materials, their correct issue, packaging and shipment.

The Technical Services Specialist is responsible for the provision and installation of necessary equipment for production and services, the repair, servicing and calibration of equipment used for production and services and the implementation of an effective schedules maintenance programme.

The Head of QA and Support Services reports to the General Manager of Schwarz Pharma Ltd. The General Manager is ultimately responsible for ensuring that adequate resources are available to meet the quality policy, and periodically reviews the quality system to ensure its continuing suitability and effectiveness.

The Production Manager has the primary responsibility for manufacture of quality products. The Production Manager is responsible for ensuring compliance with Production SOP’s and must ensure that any deviation to a process is fully and adequately investigated, documented and communicated through the correct channels.

Schwarz Pharma Ltd. has prepared a quality policy, which is appended to this attachment as Appendix C. 1.2.

ENVIRONMENTAL MANAGEMENT PROGRAMME

Schwarz Pharma Ltd. has established an environmental management programme (EMP) for implementing its environmental policy and achieving its objectives and targets. The EMP specifies the objectives to be achieved, the persons responsible and the means and timeframe by which they are to be achieved. Environmental objectives and targets are prepared and tracked as per SOP 610.011, “Setting and Monitoring of Environmental

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Attachment C nagement and Control Schwarz Phar Revised lPCL Appkaticm

Objectives and Targets”. Schwarz Pharma Ltd. aims for continuous improvement of environmental management and has implemented a number of environmental projects under the environmental, health and safety management system. Environmental projects are summarised as follows:

o Emissions to Air from Schwarz Pharma Ltd. - Target: to ensure continuous improvement on air emission rates and loadings. This includes projects involving the nitration vent, boiler emissions, fugitive emissions and continuous’ monitoring.

l Emissions to Sewer from Schwarz Pharma Ltd. - Target: To comply with present and future licensed effluent emissions. This includes projects involving start of pipe improvement, WWTP upgrade, biological improvements, black list and list I reduction/removal and trending and improved environmental communications.

l Waste Generation and Disposal from Schwarz Pharma Ltd. - Target: To minimise the volume of hazardous and non-hazardous waste requiring disposal. This includes projects on both hazardous and non-hazardous waste where an annual review of the disposal types and disposal volumes is carried out. In addition, for hazardous waste, a review of waste generation from each process is carried out. Waste minimisation programmes are developed and reviewed annually.

l Utilities Usage on Schwarz Pharma Ltd. site. - Target: To obtain annual reductions in utilities usage. It is anticipated that this five-year project will quantify usage of utilities on-site and utilise the data to generate usage reductions. In addition, high users are to be identified and minimization strategies monitored. Utilities include water usage, oil usage, electricity usage and nitrogen usage. Currently, water, steam and nitrogen are being monitored on a daily basis. Three areas have been studied for electricity usage to date with other areas planned to be monitored.

o Emissions to Ground from Schwarz Pharma Ltd.. - Target: To fully assess the impacts on ground underlying the main site and implement remedial and preventative works if necessary. This one-year project, planned for completion in Q2 2005, will quantify groundwater parameters at licensed points on the main site by sampling and analysis on a greater frequency. The potential for releases to ground from piping and bunds is also to be examined.

It is noted that projects involving the wastewater treatment plant have been prioritised, due to recent issues with its operation. The environmental, health and safety management system manual is included as Appendix Cl .3 and the environmental policy statement is included as Appendix C.1.4.


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Attachmernt C Management and Control Schwarz Pharma Revised PCL Application

8. ONGOING ASSEhMENT OF ENVIRONMENTAL PERFORMANCE

Schwarz Pharrna Ltd. provides for ongoing assessment of its environmental performance through the environmental projects as described above and as part of the IS0 -l4001- certified environmental management system. As described in Section 6 above, Schwarz Pharma Ltd. operates a series of environmental projects aimed at reducing potential environmental impacts. Further information on environmental projects is included as Appendix Cl.3 while the environmental health and safety manual is included as Appendix Cl .4.

An environmental and safety corrective action system is in place and provides a mechanism by which continuous improvement is achieved. Corrective actions are tracked on a continuous basis and the records are maintained under IS014001 and safety systems. These lists are circulated to all departments on a for-h-rightly basis. The safety specialist is responsible for the maintenance of the safety and health corrective action follow up and close out and the maintenance of the environmental corrective action system.

Specific environmental performance indicators are assessed as follows:

Process modifications resulting in improved yields, reduced wastes or the use of alternative less hazardous materials: This is covered by Project 03-04, Waste Generation and Disposal, where hazardous wastes, as produced by each process, are reviewed. This information is then used in designing waste minimisation studies, which would include process modifications where applicable, and which may result in improved yields, reduced wastes or the use of alternative less hazardous materials. In addition, improved yields are continually being pursued as part of the successful operation of the plant.

Improved process control (equipment and management) resulting in reduced waste: This is also covered by Project 03-04, Waste Generation and Disposal, where hazardous wastes as produced by specific process are reviewed. This information is then used in designing waste minimisation studies, which may include process equipment control and process management control.

Improvements in equipment cleaning resulting in reduced or alternative solvent usage: As waste solvent from cleaning is disposed of as waste, this aspect is also addressed under the environmental project 03-04, Waste Generation and Disposal, where hazardous waste production is reviewed.

Improvements in treatment/abatement systems resulting in reduced emissions: There are environmental projects underway that target reducing emissions to air, (Project 01-04) sewer (Project 0%04) and ground (Project 05-04).

Use of alternative treatment/abatement systems: Currently, the wastewater treatment plant at the site is being upgraded, with re-commissioning of the plant planned for 2005.

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A merit c nagement and Control s rz Phar Revised IPCL Appkation

Recovery, reuse, recycling of material on and off-site: Environmental project 03-4 focuses on waste generation and disposal. This includes provision to implement improvements in the waste management strategy, which would include provisions for recovery, reuse and recycling of material on and off-site.

Reduction in fugitive emissions: As part of the environmental project 01-04, a fugitive emissions study for the site is planned to be carried out and reduction recommendations implemented where possible. Testing for fugitive emissions at Schwarz Pharma Ltd. has been conducted and a study based on these results will be undertaken in 2005. At present, the major fugitive emission of concern is odour from the wastewater treatment plant, which is being addressed as part of the upgrading of the wastewater treatment plant.

Prevention of accidents and the preparation of contingency plans in the event of accident: Schwarz Pharma Ltd. has adopted and implemented procedures to identify foreseeable emergencies through the systematic analysis of its on site operations. Potential accidents and emergency situations are identified using methodologies outlined in Schwarz Pharma Ltd standard operating procedures. SOP 601.031 “Preliminary Hazard Assessment” and SOP 601.006 “HAZOP Procedure and Follow-Up” provide for the identification and assessment of major hazard scenario. In addition, the safety and environmental implications of any proposed changes to the site are reviewed as per SOP 610.014 “Environmental Health and Safety Change Control.”

An emergency plan has been developed to provide an organised response should any emergencies (e.g. fire accidental releases, explosions) occur. Procedures are also in place that test and review the emergency plan. Emergency preparedness drills and exercises are carried out on a routine basis as per SOP 620.007, “Emergency Systems Test Procedure”. All accidents/incidents on site are documented via the accident/incident reporting system, which is, covered under SOP 601.014, “Internal Accident/Incident/Near Miss Reporting”. An accidental release procedure (SOP 601.015) is in place, which details the steps to be taken following the occurrence of a chemical spill or release.

Schwarz Pharma Ltd. has a number of emergency response teams (ERT), trained in advanced emergency techniques such as fire fighting, spillage clean up and search /rescue. Each ERT has comprehensive site knowledge and is trained in the steps required to shutdown specific site buildings as required in event of an emergency. ERT provide cover for the facility 24 hrs a day with specific procedures in place to cover the operation of the ERT (“SOP 620.003 Emergency Response Team Duties”). A documented list of all fire equipment on site is maintained as per SOP 620.005 “Emergency Equipment Inventory”.

Savings in energy and material usage: Utilities usage on the Schwarz Pharma Ltd. site is addressed under project 04-04. The overall target is to obtain annual reductions in utilities usage, including water, oil, electricity and nitrogen usage. Appendix C.1.3 provides more information on these projects.

Employee training: Training of personnel is considered a key function in the successful operation of the plant and the company is certified to the F& “Excellence Through

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~ttac~~e~t C Management and Controll Schwarz Pharma Revised lPCL Application

People” Standard. All staff members receive an environmental induction, and other training is given as appropriate. Each individual manager is responsible for identifying the training requirements of personnel within their departments and for ensuring that departmental personnel receive the necessary environmental, health and safety training to ensure conformance with the companies’ environmental health and safety policy. It is the individual managers’ responsibility to determine the level of experience, competence and training necessary to ensure the capability of personnel; especially those carrying out specialised environmental, health and safety management functions. Training records are kept by the Human Resources Co-ordinator.

Complaints recording and investigation. A standard operating procedure (SOP 610.015) is in place to cover internal and external communications. External communications include such issues as environmental complaints, queries regarding environmental health and safety issues, environmental health and safety records and communications with external regulatory bodies such as the EPA, HSA, County Council, Shannon Development and other interested parties. Internal communications refer to the transfer of environmental health and safety information between the various levels and functions within Schwarz Pharma Ltd. Communications take place through a variety of methods including electronic mail, memos, training and meetings. Any complaints that are received are investigated by Schwarz Pharma Ltd. as per SOP 606.031 and a summary of complaints and actions arising from the complaints is included in Schwarz Pharma Ltd. Annual Environmental Report.

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Schwarz Pharma Revised IPCL Application Attachment C

Appendix Cl.1 IS0 14001 Certificate

Attachment Cdoc

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Appendix Cl .2 Quality Policy

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CHWAR ARMA

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SCHWARZ PHARMA

LIMITED

ENVIRONMENT

~HEALTH & SAFETY

Prepared by: Dermot Hanrahan Safety and Environment Officer Systems Approved by: John O’Donoghue Safety and Environment Mqr Approved by: Bernie Harten General Manager

Effective Date: Revision No:

4

Date:

Date:

Date:

Previous Rev No:

3

Copy Number I I

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Environmental Health & .iafety Management System Manual

Section B 1 Page2of34 Revision No 3 Previous Revision 1 Prepared by Dermot Hanrahan 1 Safety & Environment Officer Systems

Section A

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Environmental Health & Safety Management System Manual

Section B Revision No 3 Prepared by Dermot Hanrahan

1 Page 3 of34 Previous Revision 1

1 Safety & Environment Officer Systems

Section

4.4.6

Index of Contents SEVESO II Requirement Page No Operational Control X 1 27

4.4.7 Emergency Preparedness and Response X 28

4.5 Checking and Corrective Action 30

4.5.1 Monitoting Performance - Health and Safety X 30

4.5.2 Monitoting Performance - Environmental Protection 30

4.5.3 Non-Conformance and corrective and preventative action X 31

4.5.4 Records X 31

4.5.5 Environmental Health & Safety Management System Audit X 33

4.6 Management Review X 33

Revision Record X 34

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. . :

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Environmental Health & Safety Management Svstem Manual

Section Revision No Prepared by

”

B 1 Page 4 of 34 3 Previous Revision 1

Dennot Ham-&an 1 Safety & Environment Officer Systems

SCHWARZ PHARMA LIMITED, INTRODUCTION

Section B

1.1 Site Development History.

In 1976 SIFA Limited (the original company name) was established in Bay 130 of the Shannon Industrial

Estate to manufacture Nitrate compounds used in the treatment of Cardiovascular related illnesses and

these compounds continue to be the main products manufactured at this location. In 1980 the construction

of a new manufacturing facility commenced on a green field site located within the Shannon Industrial

Estate approximately 1Km north east of Bay 130 and production commenced in 1982. A pilot plant was

constructed in 1984 and full. Research and Development capabilities were in place by 1985. At this time

Sales and Marketing for the manufactured products was conducted by SELOC in Switzerland.

In 1990 SIFA joined SCHWARZ PHARMA Limited, an International Pharmaceutical company with

headquarters near Dtisseldorf in Germany. In 1991 the site was enlarged to 9.0 hectares and a new

lOOOm2 Administration / Laboratory building was constructed followed by the introduction of further

storage I Service and production support facilities.

In December of 1994 construction began on a &7.5m Pharmaceutical Manufacturing building which was

designed to increase the output of the slow release pellet form of the companies key products, ISOKET

(Isosorbide Dinitrate) and ELANTAN (Isosorbide Mononitrate) which had up to this point been solely

manufactured in Bay 130. The scope of the project was later extended in 1995 to include additional

capsule filling and tableting operations. In May 1995 the company obtained a Pharmaceutical

Manufacturing licence from the Irish Medicines Board and was accredited to the IS09002 standard in the

same year. The pharmaceutical plant became fully operational in 1997 and work continues on the

introduction of new technologies most notably Spray filling, Topo Granulation, GS Coater and Glatt.

In April 1996 the company was issued with an IPC (Integrated Pollution Control) Licence by the EPA

(Environmental Protection Agency) due to its inclusion under the schedule covering the manufacture of

pharmaceuticals and their intermediates.

Adherence to the effluent discharge limits on COD and Nitrates in the new IPC licence necessitated the

construction of a Wastewater Treatment Plant and this plant was constructed in 1998.

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Section B Revision No 3 Prepared by Dermot Hanrahan

1 Page 5 of 34 Previous Revision 1

1 Safety & Environment Officer Systems

In 1998 a new warehouse was added to the Pharma plant to provide extra storage facilities. In 1999 this

warehouse was converted to provide additional manufacturing capacity and a new Warehouse was

constructed. In November 1999, the company received accreditation of the IS0 14001 Standard and this

system provides the basis for management of the environmental aspects and impacts of its business.

Construction of a dedicated Nitrate Synthesis Plant commenced in June 1999 and commenced the

manufacture of Nitrates in 200 1.

The companies’ products are primarily exported to customers in Europe, North America and Asia. The

facility is also involved in the contract manufacture of pharmaceutical compounds. The name of the

company was formally changed from SIFA Limited to SCHWARZ PHARMA Limited on the 13& of May

2003.

4.

1.2 Site Location

SCHARZ PHARMA Limiteds manufacturing operations take place at two locations within the Shannon

Industrial Estate and the following Section describes the location of the sites in order to present the sites

in the context of their location.

The Industrial Estate itself is situated approximately 20 Km from Ennis and Limerick, 0.5 Km from

Shannon Town Centre and adjacent to Shannon International Airport. The larger of the two sites occupies

approximately 9.0 hectares on the northwest corner of the estate. The site borders the Shannon

International Airport to the west and is physically separated by an open culvert which carries surface

water from the immediate catchment area into the Shannon River, which is located approximately 4Km

from the Estate. To the north lies a public road; to the east lies a large green belt of hilly land that

provides a physical barrier between the SCHWARZ PHARMA facility and the Town Centre while south

of the facility lays the Industrial Estate. The closest domestic residences are in Shannon Town which is

located approximately 0.5Km from both sites.

The smaller of the two production locations (Bay 130) is located approximately lkm south-west of the

Main Site in a 1 700M2 factory unit with Shannon International Airport located to the northwest of the site

and is surrounded on all other sides by other factory units within the industrial estate, the Bay 130

building is on a long-term lease from Shannon Development. There are no particularly sensitive activities

operations or special areas of conservation within the vicinity of either facility.

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Health & Safety Management System Manual

Section B Revision No 3 I Prepared by Dermot Hanrahan

1.3 Maoufacturiw Processes

( Page 6 of 34 Previous Revision 1

) Safety & Environment Ofticer Systems

The manufacture of product is achieved through a variety of chemical reactions, which take place in a

series of chemical reactors. Following reaction completion the products are isolated on filters and dried.

The synthesis of product is primarily achieved through organic reactions and the current production

methods are essentially manual in nature. The manufacturing processes require the use of large volumes

of solvents, acids, bases and a variety of other chemical reagents. Bulk production of products including

drying takes place in the synthesis plants and this is followed by blending, milling, pelletising, tableting,

capsulation, coating and spray-filling operations in the Pharma Plant and to a lesser extent in Bay 130.

Bulk Finished Pharmaceutical product is then sent to Germany for final packaging.

1.4 Environmental Health and Safetv

1.4.1 Environment, Health and Safetv Structure

SCHWARZ PHARMA’s Environmental, Health and Safety Department is described above. The S&E

Manager is a member of the Management team and reports directly to the company’s Assistant General

Manager.

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Section B Revision No 3 Prepared by Dermot Han&an


) Safety & Environment Officer Systems

1.4.2 Legislative Framework

An integral function of this manual is to describe the framework that exists at SCHWARZ PHARMA to

ensure that all applicable statutory requirements pertinent to the environment and the health and safety of

personnel are being complied with. In this respect the following sets of regulations are applicable.

1.4.2.1 The Safetv Health and Welfare at Work Act 1989.

Compliance with the 1989 Safety Health and Welfare at Work Act is achieved through framework

described in this manual. Specific site safety procedures are present which support this manual and these

are implemented throughout the site. These safety procedures specifically address methods used to

identify on site hazards, assess the risks involved and the measures necessary to eliminate the hazards or

reduce the risk toeacceptable levels.

1.4.2.2 EC Directive on the Control of Maior Accident Hazards - Regulations 2000.

In December 2000 revised regulations were introduced to regulate sites categorised as major hazard

processing and storage sites. The regulations arising from a revised EC Directive which applies to sites

that store hazardous materials in quantities in excess of specified thresholds.

The SEVESO II Directive applies to SCHWARZ PHARMA and the requirements of the regulations are

enforced by the Health and Safety Authority.

The Directive requires companies to have in place a Major Accident Prevention Policy (MAPP) that

addresses and minimises the possibility of a major accident occurring. Essentially a MAPP refers to the

management system put in place to address and control the site major hazards.

This manual incorporates the requirements for a MAPP and is supported by a number of specific site

safety procedures. The manual integrates the requirements for both environmental management, and

safety and health management.

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d

B 1 Page 8 of34 3 Previous Revision 1

Den-not Hamahan 1 Safety & Environment Officer Systems

1.4.2.3 Environmental Protection Agencv Act - 1992

SCHWARZ PHARMA has been licensed by the EPA since April 1996 (License no: 20). Since receipt of

its licence the company has been involved in a number of environmental projects and initiatives designed

to foster continuous Environmental improvements and to promote environmental awareness, sustainable

development, clean technology. These include: -

o Construction of a New Wastewater Treatment Plant. (1998)

o Sodium Acetate Recovery ( Cleaner Technology) (1997/1998)

CI Reduction in water usage by 30% (1996/97)

•I Significant reductions in the usage of Chlorinated solvents on site. (1994- 1996)

u Received accreditation of IS0 14001 in November 1999.

The most significant incident of note with regard to SCHWARZ PHARMA LIMITED’S Environmental

performance has been in relation to the generation of a WWTP Odour in early 2003 which extended

beyond the site boundary. The EPA subsequently directed SCHWARZ PHARMA to shut down the

WWTP and work is currently underway to remediate the problem so as to allow the future operation of

the WWTP.

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Section C Revision No 3 Prepared by Dermot Han&an


( Environmental Officer Systems

Section C

Circulation List for Environmental Health & Safety Management System Manuals

Co~v Location CODY No

QA Co-Coordinator Original None

Safety and Environment Manager COPY 1

General Manager COPY 2

API Manager COPY 3

Pharmaceutical Manufacturing Manager COPY 4

Reception COPY 5

Reception Bay 13 0 COPY 6

Materials and Logistics Manager COPY 7

Quality Control Manager COPY 8

Human Resources Manager COPY 9

Facilities Manager COPY 10

Financial Controller COPY 11

Quality Assurance Manager COPY 12

Business Dev Manager COPY 13

NF’D Manager COPY 14

Asst. General Manager COPY 15

The Original/Master Copy is held in loose-leaf format by the QA Co-Coordinator. It is not stamped with a

copy number, as it will be used to make additional copies if necessary. The people who appear on the

circulation list are issued with a ‘Controlled Copy’ of this manual.

l A ‘Controlled Copy’ is a copy of the Manual, which is covered under the regulations of document

control within the facility.

l A copy of the manual will be held on the Q: drive. Any print off from the Q: drive is not a controlled

document and it is the responsibility of the person printing off the manual to ensure it is destroyed

when no longer needed or superseded.

l All revisions will be described on a Revision Record as per QA SOP 100.005 which is attached to

this Document.

, . ”

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J

D I 1 Page 10 of34 3 Previous Revision 1

Dermot Hamahan 1 Environmental Officer Systems

Section D 1.0 Companv Information

Company Name:

Address:

Parent Company:

Telephone No:

&l&z

Gear founded:

No of Emplovees:

Business:

Production Cycles:

SCHWARZ PHARMA LIMITED

Shannon Industrial Estate, Co. Clare, Ireland.

Schwarz Pharma, Monheim, Germany.

+353-(0)61-7 14100

+353-(0)61-714101

1976

circa. 270

Manufacture of Fine Chemicals and Bulk Pharmaceutical products.

2.0

Bay 130 2 x 8 hr shifts 5 days per week Main Site 7 days per week

Responsibilities

It shall be the responsibility of the Safety and Environmental Officer Systems to ensure

that this manual reflects current practice at all times.

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Section D Revision No 3 Prepared by Dertnot Han&an


1 Environmental Officer Systems

3.0 Definitions

3.1 Continual Improvement:

The process of enhancing SCHWARZ PHARMA’s environmental health and safety

management system, so as to achieve improvements in overall environmental health and

safety performance.

3.2 Environment:

Surroundings in which SCHWAEU PHARMA operates including air, water, land, natural

resources, flora, fauna, humans and their interrelation.

3.3 Environmental Aspect:

Element of SCHWARZ PHARMA’s activities, products or services, which can interact

with the environment.

3.4 Environmental Impact:

Any change to the Environment, whether adverse of beneficial, wholly or partially

resulting from SCHWARZ P HARMA’s activities, products, or services.

3.5 Environmental Health & Safety (EHS) Management System:

The Environmental Health & Safety Management System is an element of SCHWARZ

PHARMA’s overall integrated site management system which includes planned

activities, responsibilities, practices, procedures processes and the resources necessary

for developing, implementing, achieving, reviewing and maintaining an EHS policy.

3.7 Environmental, Health and Safety Objectives.

Objectives and targets set annually to support and develop the EHS management system.

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Environmental Health & Safety Management I System Manual

Section D 1 Page 12 of 34 Revision No 3 I Previous Revision ) Prepared by Dermot Hanrahan 1 Environmental Officer Systems

3.8 Environmental, Health and Safety Performance

Measurable results of the Environmental Health & Safety Management System relate to

SCHWARZ PHARMA’s control of its environmental aspects and impacts.

3.9 Environmental, Health and Safety Policy:

Statement by SCHWARZ PHARMA of its intentions and principles with regard to its

overall environmental health and safety performance. The policy provides the framework

for action and for the setting of its environmental, health and safety objectives and targets.

3.10 Hazard:

A chemical, physical or biological condition that has the potential for causing damage to

people, property, or the environment.

3.11 Consequence:

A measure of the expected effects of an incident outcome from a hazard.

3.12 Risk:

A measure of human injury, environmental damage, or economic loss in terms of both the

likelihood and the magnitude of the loss or injury.

3.13 Risk Assessment:

The process by which the results of a risk analysis are used to make decisions, either to

judge that the risk is at an acceptable level or judge that the risk is required to be reduced.

3.14 Interested party:

Individual or group concerned with or affected by SCHWARZ PHARMA’s

environmental performance.

3.15 Organisation

Within the context of the standard the Organisation refers to SCHWARZ PHARMA

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Section D Revision No

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Prepared by Derrnot Hanrahan 1 Environmental Offker Systems

Limited.

3.16 Prevention of Pollution

Pollution prevention involves the use of processes, practices, materials or products that

avoid, reduce or control pollution. These include such techniques as recycling, reuse,

recovery, effluent treatment, process changes, control mechanisms, efficient use of

resources and material substitution. Note: - The potential benefits of Prevention of

Pollution include the reduction of adverse environmental effects and improved efficiency.

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Y


1 Environmental Offrcer Systems

4.0 Environmental Health & Safety Management System Requirements

4.1 Manual Descriation

4.1.1 Purpose of Manual

The purpose of this Manual is to describe the Environmental Health & Safety

Management System as it pertains to SCHWARZ PHARMA Limited.

4.1.2 Scope of Manual

This Environmental Health and Safety Manual apply to the management system operated

within SCHWARZ PHARMA Limited and as required by:

. lSO14001(1996) standard.

l Environmental Protection Agency Act - 1992.

l Safety, Health and Welfare at Work Act 1989.

l European Communities (Control of Major Accident Hazards Involving

Dangerous Substances) Regulations, 2000.

The main components of the manual include:

e Organisation structure.

l Environmental Aspects and Impacts

l Hazard Identification and Risk Assessment

0 Operational Control.

l Management of Change.

l Emergency Planning.

l Monitoring Performance - Objectives and Targets.

* Audit and Review.

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4.1.3 Format of Manual

SCHWARZ PHARMA operates an integrated approach to the management of

environmental, health and safety aspects of the site. The format of this Manual is such

that it corresponds to the sections outlined in the 1 SO14001 (1996) standard for

Environmental Management and also incorporates the requirements as set out in Annex

III of the SEVESO II Directive.

SCHWARZ PHARMA is an accredited operator of the IS0 14001 Environmental

Management System. The system is accredited by the National Standards Authority of

Ireland. (NSAI) /*

The Manual is a top-level document and the core procedures of the system are referenced

within the main body of the manual. All other procedures with Environmental Health &

Safety implications are referenced to in a listing of all Environmental Health & Safety

Departmental procedures which is maintained as per SOP 100.017 “Update of SOP

Lists.

Copies of this Manual will be distributed as outlined in Section 4.4.4 and the

Departmental manager within that area is responsible for that copy of the Manual. The

manual may also be viewed on the Q-Drive of the facilities computer system under

Q:\S&E\EnvManual. The Manual is controlled as per SOP 610.017 “Control of the

Environmental Health & Safetv Management System Manual “

4.1.4 Document Control

The key Environmental Health & Safety operating procedures for the facility are

referenced to within this Manual. Any reference to other documents implies its latest

revision unless otherwise stated. The Document control of this manual is covered under

SOP 100.005 Distribution of Standard Operating Procedures” No changes to the

Manual may take place without the approval of the following:

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l Safety and Environment Manager

l General Manager

SCHWARZ PHARMA Limited is committed to establishing and maintaining an

Environment Health and Safety Management System compliant with the requirements of:

. IS014001 (1996) standard.

l Environmental Protection Agency Act - 1992.




This Manual and its accompanying documentation provide the means by which

SCHWARZ PHARMA’ s Environmental Health and Safety Management System is

controlled.

4.2 Environmental Health and Safety Policv

SCHWARZ PHARMA Limited has put in place an Environmental Health and Safety Policy, as outlined

below, which is endorsed by senior management. The policy is proportionate to the scale of the

companies activities, products and services, includes a commitment to continual improvement, accident

and ill-health prevention and environmental protection. This commitment also includes legal compliance

and provides the framework for the setting and reviewing of environmental health and safety objectives

and targets. This policy is documented and implemented and is communicated to all employees though

ongoing training. The policy is also available to the public.

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1 Page 17of34 Previous Revision )

1 Environmental Offker Systems

SCHWARZ Environmental Health & Safety PHARMA

SCHWARZ PHARMA Limited is a market leader in the development and manufacture of a wide variety of Fine Chemicals and Pharmaceutical products, which are primarily used for the treatment of cardiovascular disease, urology & neurology. As an organisation SCHWARZ PHARMA Limited considers the effective management of the natural and workplace environment to be one of its highest organisational priorities as reflected through its commitment to Environmental Health and Safety compliance.

Our Commitment to Environment, Health and Safety SCHWARZ PHARMA Limited regards provision of a Safe workplace and protection of the Environment as an integral part of its business. It undertakes to conduct its activities in a manner which adheres to the highest Environmental Health and Safety standards and strives towards ensuring the protection of its employees, contractors, members of the public and the Environment in which it operates. The company’s Environmental Health & Safety Management System Manual outlines the framework for implementing these objectives.

Specifically we commit to the following: - Contikal Improvement. We are-committed to improving our overall Environmental Health and Safety performance and we will strive to demonstrate this commitment to continuous improvement through the setting and reviewing of objectives and targets.

Accident Prevention. We will strive to prevent accidents through learning from our own previous experiences and by adherence to risk assessment programmes and safe systems of work to ensure a safer work environment.

Compliance. We will comply with all applicable Environmental Health and Safety regulatory and legislative requirements.

Major Accident and Emergency Planning. We will comply with the requirements of the SEVESO II Directive by adhering to the provisions of the Major Accident Prevention Plan (MAPP) and the implementation of all other safety systems required under the conditions of the Directive.

Employees. We will ensure that all our employees are made fully aware of their Environmental Health and Safety responsibilities and that they are provided with the training and information necessary to ensure that they perform their work in a manner which ensures their safety, the safety of others and protection of the environment. The updated sections of the companies Safety Statement will be communicated to relevant employees when revised.

Conservation. We will strive to conserve natural resources through the responsible and efficient use of raw materials and energy, and through the development of onsite waste reduction programmes.

Pollution Control. We will strive to prevent pollution through a combination of substitution, elimination, engineering controls and monitoring, while abiding by the principles of Cleaner Technology and BAT (Best Available Technology).

Communication. We will maintain good relations with the local community and local industry in relation to all Environmental Health and Safety issues.

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D I 3

Dermot Hanrahan

( Page 18 of 34 Previous Revision 1


. Suppliers and Contractors. We will work with our suppliers and contractors to enhance Environmental Health and Safety performance.

. Availability. Our Environmental Health and Safety policy is available to all our employees & contractors in designated areas of the plant. We will make the policy available to the public on request.

The General Manager is responsible for the effective implementation of the Environmental, Health and Safety policy throughout the sites. Policy implementation is achieved through the Departmental Managers and company line management structure, with the Safety and Environment Department playing a specialist role in providing advice, direction and support to assist management and employees fulfil the policy objectives. All employees and users of the site are responsible for environmental protection and for ensuring they work and contribute to a healthy and safe workplace.

Dr. Bernie Harten General vanager

Date Date

Rev. No. I Dated: 22/07/2003

.

John O’Donoghue Safety & Environment Manager

Prev. Rev.: 0 Dated: 1611 O/2001

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4.3 Planning

Planning is an integral part of the Environmental Health & Safety Management System as it ensures that

the ongoing programs within the company are consistent with the companies Environmental Health &

Safety Policy. The Facilities Manager holds all existing planning applications, planning appeals, planning

a permissions and associated studies in the Engineering Offices.

4.3.1 Environmental Aspects.

SCHWARZ PHARMA Limited has established a methodology for assessing and rating

the significance of the environmental aspects of its activities. This approach involves an

identification and quantification of the environmental aspects of SCHWARZ

IkARMA’s activities, services and products. The method of evaluation is described in

SOP 610.004. “Identification and Evaluation of Environmental Aspects and

impacts“The Environmental impacts of the activities, products and services are

numerically rated for both environmental and business concerns under the following

headings.

Environmental Concerns include: Scale of the Impact

Severity of the Impact

Frequency of Occurrence

Business Concerns include: - Potential Regulatory and Legal

Exposure Effect on companies Public Image

Cost of changing the impact

The aspects with the highest ratings are classed as SCHWARZ PHARMA’s most

significant Environmental Aspects and hence effort is focused on the reduction of the

environmental impacts of these aspects. All of the identified are maintained in a Register,

which is updated on a continuous basis.

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1 Environmental Offrcer Systems

4.3.2 Hazard Identification and Risk Assessment

To secure the safety and health of all personnel within SCHWARZ PHARMA it is

necessary to identify the hazards on site, analyse the consequences of these hazards, and

make an assessment of the risks involved.

The method of hazard identification within SCHWARZ PHARMA can essentially be

divided into two areas, Process Hazard Studies and Occupational Hazards.

Figure I: Hazard Identification

The evaluation of process hazards is concerned with identifying the major

environmental, health and safety hazards associated with the storage, manufacture and

handling of raw materials, intermediates and waste streams on site.

The components for conducting process hazard studies is shown in Figure 2 and outlined

through the following SOPS:

HAZOP Procedure and Follow-up

Preliminary Hazard Analysis

Equipment Design Evaluation

Basis of Environment Health and Safety Report

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Section D Revision No 3 I Prepared by Dermot Hanrahan

( Page21 of34 Previous Revision )

) Environmental Offker Systems

Chemical Reaction Hazards

Figure 2: Protocol for Conducting Process Hazard Studies

CRH SOP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +

L--- - - - - - - - - - - r---- -------I

I Environmental Protection Reports

HAZOP SOP

,.. .,....,..........,,,..............................,.. . . +

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4.3.2.2 Occuoational Hazards

The evaluation of occupational hazards is concerned with the assessment of hazards

associated with individual work activities carried out by all personnel on site. These

include chemical, biological, ergonomic, physical hazards and work practices that may

lead to a high risk of injury or ill health.

In consideration of our production activities particular emphasis is put on evaluating the

safe handling of hazardous materials.

Occupational hazard evaluation overlaps with and complements the process hazard

studies carried out on site.

The process of conducting an Occupational hazard studies is outlined in SOP 601.028

“Occupational Risk Assessments”

4.3.2.3 Registers of Environmental AsDects and Hazard Studies

SCHWARZ PHARMA maintains a register which documents all of the Environmental

Aspects and impacts associated with its activities, products and services. Registers are

also kept of all Process Hazard and Occupational Hazard studies which have been

undertaken. These registers are live documents and are updated as necessary to reflect the

introduction new Environmental or Safety Hazards as they occur.

The Safety and Environmental Officer Systems is responsible for maintaining these

Registers.

4.3.3 Management of Change

SCHWARZ PHARMA monitors and evaluates all change at the facility as per SOP

610.014 “Environmental Health and Safety Change Control”. Any change which has

either an associated environmental, or health and safety aspect must be reviewed and

approved by the Safety and Environmental Manager before it can be proceeded with. If

the change is of a significant nature an evaluation of the aspect and (or) an assessment of

the associated risk must take place.

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1 Environmental Oficer Svstems

4.3.4 Legal and Other Requirements.

The company maintains a Register of Environmental Health and Safety Legislation

relevant to SCHWARZ PHARMA’s operations. The Register identifies all relevant

environmental health and safety legislation and regulations, and provides clarification

with regard to the application of the law to the issues associated with its operations. An

external contracted source provides SCHWARZ PHARMA with this Register and it is

updated annually. The Legal Register is ultimately the responsibility of the Safety and

Environment Manager; who is also responsible for ensuring that the register is applicable

to all Environmental Health and Safety aspects of SCHWARZ PHARMA’s activities,

products and services and also for ensuring that SCHWARZ PHARMA Limited is ,* compliant with its legislative requirements.

Updating of new and pending environmental legislation is provided as per SOP 610.012

“Legal Register”.

Legal and other requirements are considered during the setting and monitoring of

SCHWARZ PHARMA’s Objectives and Targets so that applicable new legislation may

be incorporated into the Environmental Health & Safety Management System as

appropriate. The Register of Environmental Health and Safety Legislation as well as hard

copies of the applicable licenses are held in the Safety and Environment Managers

Office.

Amendments and updates to Legal requirements are communicated to the relevant

personnel by the Safety and Environment Manager via emails, meetings and training

sessions.

4.3.5 Monitoring Performance - Objectives and Targets

The setting and completion of Environmental Health and Safety Objectives and Targets is

an integral part of the continued development of an Environmental Health & Safety

Management System. SCHWARZ PHARMA’s Objectives and Targets are set and

updated annually by senior management and are based on a review of the management

system components. The objective and targets are also consistent with the company’s

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“Environmenlal Health and Safety Policy Statement”. Environmental Targets are set which are specific, measurable, attainable, realistic and set

within a given time frame. SCHWARZ PHARMA’s Environmental Objectives and

Targets are identified, managed and controlled as per SOP 610.011 “Setting and

Monitoring of Environmental Objectives and Targets”. Progress reports on the

Environmental Objectives and Targets are reported to the management team on a

quarterly basis as per “SOP 610.0 15 Internal and External communications”. Safety and

Health Objectives and Targets are managed on a less formal basis however a

system is being developed to manage Safety and Health Objectives and Targets

on a formal basis within the scope of the management system.

4.3.6 Environmental Health and Safety Management Program

SCHWARZ PHARMA has established an Environmental Management Programme

(EMP) for implementing its Environmental Policy and achieving its objectives and

targets. The programme specifies the objectives to be achieved, the persons responsible

and the means and timeframe by which they are to be achieved. Environmental

Objectives and targets are prepared and tracked as per SOP 610.011 Setting and

Monitoring of Environmental Objectives and Targets. Work is in progress to formalise

the management of Safety and Health objectives within the scope of a Health and Safety

management programme.

4.4 Implementation and Operation

4.4.1 Structure and Responsibilitv

SCHWARZ PHARMA’s Organisation chart is presented in Section 4.1 of the “Quality

Assurance Manual”. The Quality Manual lists responsibilities for each relevant position

pertaining to Quality and Production.

In addition to the Statutory Environmental Health and Safety responsibilities of

Management and Employees specific Environmental Health and Safety responsibilities

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Section D 1 Page 25 of 34 Revision No 3 Previous Revision 1

, Prepared by Dermot Ham&an 1 Environmental Offker Systems

are defined within individual standard operating procedures. These responsibilities are

reinforced within SCHWARZ PHARMA through detailed job descriptions, clear

measures of job performance and annual reviews of individual performance. Annual

reviews include the setting of individual environmental health and safety objectives and

appraisal of performance against these objectives at year-end. The Human Resources

Manager provides the means for co-ordinating and implementing this practice.

Environmental health and safety responsibility and accountability are an integral part of

each employee’s job. The communication of individual environmental responsibilities is

achieved through training and standard operating procedures. Individual managers are

responsible for achieving environmental health and safety performance targets as outlined .t in the Environmental Health and Safety Management Programme. They are also

responsible for the operational control of specific environmental health and safety aspects

within their area of responsibility, the identification, arrangement and completion of

training and for the control and update of environmental health and safety documentation

and records.

4.4.2 TraininP. Awareness and Competence.

Company training is completed as outlined in SOP750.002 “Training Needs

Analysis and Planning”. The implementation, recording and evaluation of

identified training is subsequently completed as outlined in the procedures

750.001

750.002

750.003

750.004

750.005

750.006

Training

Training Needs Analysis and Planning

Training Records

Implementation of Training

Evaluation and Review of Training Effectiveness

Provision of an external Employee Assistance Programme (EAP) for SCHWARZ PHARMA Limited.

outlined above. Each individual manager is responsible for identifying the

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) Page 26 of 34 Previous Revision )

( Environmental Officer Systems

training requirements of personnel within their departments and for ensuring

that departmental personnel receive the necessary environmental, health and

safety training to ensure conformance with the companies’ environmental health

and safety policy. It is the individual managers’ responsibility to determine the

level of experience, competence and training necessary to ensure the capability of

personnel; especially those carrying out specialised environmental, health and

safety management functions. Records of Environmental Health and Safety

Training are kept by the Human Resources Co-ordinator.

4.4.3 Communication. e

Receipt of documentation and response to all Internal and External

communications is carried out as per SOP 610.015 “Internal and External

Communications. External communications include such issues as environmental

complaints, queries regarding environmental health and safety issues,

environmental health and safety records and communications with External

Regulatory bodies such as the EPA, HSA, County Council, Shannon

Development and other interested parties. Internal communications refer to the

transfer of Environmental Health and Safety information between the various

levels and functions within SCHWARZ PHARMA. Communications take place

through a variety of methods including electronic mail, memos, training and

meetings.

4.4.4 Environmental Health and Safetv Manapement System Documentation.

The core elements of SCHWARZ PHARMA’s environmental health and safety

management system and their interaction are described within this Manual, are

provided within the main body of the Manual which provide direction to all

related documentation.

The Environmental Health & Safety Management System Manual is distributed

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as outlined on page 6 of the Manual. The management team will be informed of

any changes or revisions to this manual as they occur. All revisions will be

described on a revision record as per “SOP 100.005 Distribution of Standard

Operating Procedures”. Document Control of this manual will also be controlled

as per this procedure.

4.4.5 Document Control.

All documents generated for the system will be controlled under

SCHWARZ PHARMA’s existing IS09002 documentation control system

while local control of documentation within each department is covered

under SOP 100.022 “Localised Document Control”. All operating

procedures are reviewed as per SOP 100.007 “Annual Review of Standard

Operating Procedures” and a listing of SOP’s generated by the EHS

Department will be maintained by the S&E Secretary / Receptionist as per

SOP 100.017 “Update of SOP Lists “

The listing contains details of:

I. SOP Number

II. SOP Title

III. Effective Date LV. Revision Number

IV. Revision Number

Listings of all SOP’s covered under SCHWARZ PHAFUGA’s documentation

system are maintained by the QA Administrator, the listings are also available on

the Q Drive of the plants computer system.

4.4.6 Operational Control

Documented procedures have been established by SCHWARZ PHARMA which,

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cover all of the identified environmental aspects of its activities products and

services. Procedures are also in place which provide instructions for safe

operation including maintenance of plant, processes and equipment. All

procedures are designed to ensure compliance with Environmental Health and

Safety Policy. A master list of all procedures is located on the Q Drive of the

facilities computer system and the listings are found under their department of

origin. A general listing of all procedures with environmental health and safety

implications is maintained by the Environmental Officer Systems on the N drive

of the facility computer system under ISO14001- “Index of Environmental

Health and Safety Significant Procedures “.

Maintenance programs are carried out as per documented procedures and

schedules, which are held within the Engineering Department.

Purchasing procedures for the control of purchased materials and services are

described in SOP 40 1.003 “Purchasing Order Processing and Review “and SOP

401.004” Raw Material Purchase Order Processing” and other associated

procedures. All suppliers are evaluated and raw materials qualification is

documented in SOP 108.005 “Vendor Approval, audits of the vendors are

carried out on a periodic basis. All Raw materials and chemicals on site are

controlled as per SOP 403.00 1 “Material Code Numbers”

4.4.7 Emergency Preparedness and Response.

SCHWARZ PHARMA has adopted and implemented procedures to identify

foreseeable emergencies through the systematic analysis of its on site operations.

An Emergency Plan has been developed to provide an organised response to such

emergencies and procedures are also in place which test and review the

emergency plan.

As part of SCHWARZ PHARMA’s Emergency

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J

D 1 Page 29 of 34 3 Previous Revision 1

Dermot Hanrahan ) Environmental Officer Systems

Preparedness drills and exercises are carried out on a routine basis as per SOP

620.007 Emergency Systems Test Procedure. All accidents/incidents on site are

documented via the Accident/Incident reporting system, which is, covered under

SOP 601 .O 14 “Internal Accident/Incident/Near Miss Reporting” and potential

accidents and emergency situations are identified using methodologies outlined

in:

l SOP 60 1.03 1”Preliminary Hazard Assessment” for the identification

and assessment of major hazard scenarios.

,. l SOP 601.006” HAZOP Procedure and follow-up”.

l SOP 610.014 “Environmental Health and Safety Change Control.”

which is used to determine the Safety and Environmental

implications of change before it is introduced onto the site. This

procedure is the primary method used to monitor and control change.

An Emergency Plan which is outlined in SOP 620.004 has been developed

which details SCHWARZ PHARMA’s planned responses in the event of an

emergency situations such as fire, accidental releases, explosions and other

situations which have the potential to cause damage to personnel, buildings,

equipment and the environmental damage. An Accidental Release Procedure

(SOP 601 .015) is in place which, details the steps to be taken following the

occurrence of a Chemical Spill or release.

A specialist Emergency Response service is also in place on site. This service

consists of teams trained in advanced emergency techniques such as fire fighting,

spillage clean up and search /rescue. The ERT has comprehensive site knowledge

and is trained in the steps required to shutdown specific site buildings required in

the event of an emergency. The ERT( Emergency Response Team) provide

cover for the facility 24 hrs a day and specific procedures are in place which

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1 Page 30 of 34 Previous Revision )

) Environmental Offker Systems

cover the operation of the ERT i.e. SOP 620.003 Emergency Response Team

duties, a documented list of all Fire equipment on site is maintained as per SOP

620.005 Emergency Equipment Inventory.

4.5 Checking and Corrective Action

4.5.1 Monitoring Performance -Health & Safetv

SCHWARZ PHARMA’s overall objective as stated in Section 4.2 is to conduct

operations on site in a manner which strives to protect the health and safety of all

personnel and protect the environment. However, when incidents and injuries do occur

the results and information provided need to be continuously monitored and assessed as

they give valuable information on the effectiveness of the environmental health and .*

safety management system.

Statistics on accident and incident information are compiled and reviewed by the Safety

& Environment Department. These results are used to assist in making decisions on

improving the environmental health and safety management system. Accident and

incident analysis is specifically addressed under SOP 60 1 .O 14” Internal

Accident/Incident Near Miss Reporting”.

It should be noted that while these statistics help identify Accident and Incident trends

they:

1. Are not predictive measurements of incident and injury control (i.e. they do not

predict if incidents will occur).

2. Should only be considered as a guide to assessing environmental health and safety

management system performance.

4.5.2 Monitoring Performance - Environmental Protection

Documented procedures are in place which cover the monitoring and measuring

of all on site activities and processes which, significantly affect or have the

potential to significantly affect the environment. Monitoring and measurement

activities on site are specifically covered under SOP 610.003” Monitoring and

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Environmental Health & Safety Management I System Manual

Section D Revision No 3 I Prepared by Dermot Han&an

1 Page31 of34 Previous Revision )

( Environmental Offker Systems

Analysis Requirements”.

SCHWARZ PHARMA has in place an electronic system known as PEMAC

which is used to track the maintenance histories of all plant items. The up-to-date

maintenance history any plant item can thereby by accessed and reviewed at any

time. The system is controlled under SOP 30 1.127 PEMAC Maintenance System.

Safety Critical Equipment is identified at the validation stage of all new

equipment installations. The inspection frequency and spares requirements are

defined as this point.

4.5.3 Non-conformance, corrective and preventive action. .*

It is the dual responsibility of the Safety and Environmental Manager and the

Environmental Officer Systems to handle and investigate all environmental

health and safety non-conformances as per SOP 6 10.018 Enviromnental Health

& Safety Corrective Actions. The relevant functional and departmental heads are

responsible for ensuring that all Corrective Actions within their areas are

completed as per the agreed schedules.

Corrective Actions are tracked on a continuous basis and the records are

maintained on the N drive of the facilities computer system under IS014001 and

Safety Systems. These lists are circulated to all departments on a fortnightly

basis. The Safety and Health Officer (Operations) is responsible for the

maintenance of the Safety and Health Corrective Action follow up and close out

while the Safety and Environment Officer Systems maintains the Environmental

Corrective Action System.

The Corrective Action System is one of the main vehicles used for the

continuous improvement of the SCHWARZ PHARMA Limited Environmental

Health & Safety Management System.

4.5.4 Records.

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I ~~_____ Environmental Health & Safety Management I System Manual

Section D Revision No 3 I Prepared by Dermot Hanrahan



If is the responsibility of the Environmental Officer Systems to ensure that all

relevant environmental health and safety records are maintained in compliance

with the requirements of:

l 15014001(1996) standard.




l Environmental Protection Agency - IPC License.

. Identification, collection, indexing, filing, storage, maintenance and disposal of

environmental health and safety records is carried out as per SOP 610.002

Control of Safetv and Environmental Records.

Environmental health and safety records are retained in order to:

. Demonstrate compliance with the requirements of 1 SO1400 1.

. Demonstrate compliance with the requirements of the IPC licence.

. Demonstrate compliance with all Health and Safety legislation.

. Provide a data record of facility operations for an Environmental Health and

Safety perspective.

Records pertinent to environmental health and safety issues onsite include but are

not limited to:

l Process and Occupational hazard studies.

l Environmental Monitoring and Analysis Results

l Accident/Incident Records.

l Calibration Records

l Waste Disposal Records

l Auditing Records

l Corrective Actions

l Objectives and Targets

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l Preventative Maintenance.

4.5.5 Environment Health and Safetv Management &stem Audit.

SCHWARZ PHARMA routinely conducts audits of its Environmental Health &

Safety Management System in accordance with SOP 610.001 “Internal

Environmental Auditing & SOP 601.026 “Internal Safety Auditing.” The purpose

of these audits is to determine whether or not the system is operating within the

parameters defined under the terms of the Environmental Health and Safety

Policy. ,* The Safety & Environment Department has overall responsibility for internal

Environmental Health and Safety Audits, with specific responsibility for

assigning Audit frequencies, responsibilities, audit scope and methodologies

where necessary. The Department is also responsible for ensuring that corrective

actions raised during the Audits are followed up as per SOP 114.002 “Non-

Conformance and Corrective Action”.

Schedules of all pending Environmental Health and Safety Audits are held on the

N drive of the facilities computer system under IS014001/Audit

Schedule/Current Audit Schedule and these are updated as necessary.

A team of trained Environmental and Health & Safety Auditors carry out onsite

Audits as per the agreed schedules. Regular auditing of the Environmental Health

& Safety Management System ensures its continuous improvement.

4.6 Management Review

The Management Review Process for the environmental elements of the

Environmental Health & Safety Management System is described in SOP

610.005. “Environmental Management Review”. At a minimum, quarterly

reports on the status of the Environmental Management issues -are presented to

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Section D Revision No 3 I Prepared by Dermot Haruahan


) Environmental Officer Systems

r*

senior management by the Safety and Environment Manager. An annual review

is also carried out in which all available data pertaining to SCHWARZ

PHARMA’s environmental performance is reviewed by SCHWARZ

PHARMA’s senior management. The review which is documented and carried

out in accordance with SOP 610.005, addresses the possible need for change in

SCHWARZ PHARMA’s Environmental Health and Safety Policy, its objectives

and targets and any other elements of the Environmental Health and Safety

Management System which may need to be modified based on available

Environmental data, audit findings and changing circumstances. The

management review of Health and Safety issues is covered in a less formal basis

however work is in progress to develop a system which provides for a more

formal review of Health and Safety issues.

The aim of the Environment or Health and Safety reviews is to

l Ensure the continued improvement of SCHWARZ PHARMA’s EHS

performance

l Minimise the risk of accidents and incidents occurring on site

l Ensure the protection of the environment

l Ensure the effectiveness of SCHWARZ PHARMA’s Environmental Health

and Safety Management System.

The Safety & Environment Manager holds records of all Environmental

Reviews.

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REVISION RECORD

TITLE : ENVIRONMENT HEALTH AND SAFETY MANAGEMENT SYSTEM MANUAL

Revision Requested By Reason for alteration Effective Date

Number

0 D. Ham&an Original 28 Ott 1999

1 D. Hanrahan Update to reflect changes in plant. Status and addition 06 Nov 2000

of new documentation

2 D.Hanrahan Update SOP references to reflect changes in titles and 12June2002

department of origin.

3 D.Hanrahan Integration of Health and Safety Policy with the 23 Ott 2002

existing Environmental Policy and updating of manual

to corporate the requirements of the SEVESO II EC

Directive Major Hazard Regulations 2000 applicable

to SCHWARZ PHARMA.

4 D,;Hanrahan Updates to completed to reflect: 8 Sept 2003 1. Change in company name to SCHWARZ PHARMA

Limited

2. Revised EHS Policy Document

3. WWTP Odour issue

4. Changed Organisation structure

5. Reference to all Training Procedures

6. Reference to PEMAC System

7. Reference to Safety Critical Equipment

8. Reference to Emergency Shutdown of the site.

. ..?.

3: 1.“’ ,:. .

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Site Management and Control Schwarz Pharma Ltd. Pharma Ltd ...

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