AuditReportAarti_Tarapur[1]

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Supplier / Sub-contractor / Service Provider

Audit Report

Page 1 of 12

Company / Site Aarti Drugs Ltd Tarapur

Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004

PART 1 – SUMMARY

1. COMPANY AUDITED

Man

uf actur ingAddr ess

Plot E-9/3-4 MIDC Tarapur Tal.Palghar Dist. Thane 401506 Maharashtra India

Typeof Audit

GMPQuality System

For Cause Non GMP

Prospective

Subcontractor: Y N

Supplier: Y N API Excipient Packaging Materials Clinical/R&D Information System Equipment

Oth R M t i l



Others : Raw Material


Audit Report

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Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004

4. NATURE OF BUSINESS

MANUFACTURE OF PARACHLOROBENZENESULFOCHLORURE




Audit Report

Page 3 of 12


Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004

5. PARTICIPANTS

Jean Saint-Germain IQC Process Development Director

Nasir Y Shaikh QA/QC manager

Sanjay Patil Works manager Gala Sales manager

6. PURPOSE / SCOPE OF AUDIT

Products/servi

cereviewed

PCBSC

Site(s)requesting

the

Single Site Multi-site(specify):




Audit Report

Page 4 of 12


Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004

8. RECOMMENDATION / DECISION OF THE AUDITORS

The site was found clean and well ordered. Material management was found satisfactory.

The major issues result in poor management of change control on site and subsequent information of

customers and monitoring of EDC content ( IPC and final release ) in industrial batches.Change Control management should be improve to clearly assess date of implementation of new

PCBSC process and validation of EDC method is mandatory before any order of PCBSC material.

Use of class 1 solvent should be avoided in manufacturing of reagent and/or starting materials.

Lead Auditor:




Audit Report

Page 5 of 12


Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004

PART 2 - REPORT

8. GENERAL ORGANISATIONAarti Drugs Ltd is part of global group Aarti Industries

Aarti has started its operations in the year 1975 in the name of alchemie labs in a small of way with asingle product namely Dimentyl sulphate.( DMS )Today Aarti is one of the leading supplier to global manufacturers of Dyes, Pigments,Agrochemicals, Pharmaceuticals & rubber chemicals. Aarti is one of the largest producers of Benzene based basic and intermediate chemicals in India. It has corporate office in Mumbai &representatives in U.S.A & Europe .Aarti has 16 manufacturing units spread across Gujarat & Maharashtra and a Research &Development unit based in Dombivli.Aarti has customers spread across the globe in 60 countries with major presence in USA, Europe,

Japan & India.AartiI has attained a group turnover of US $ 515 million in the year April 2009 – March 2010.The site located in Tarapur is dedicated to manufacture of reagents and intermediates. It employs 76people and certified ISO 9001/2008. it plans to apply for ISO 14001 which is a good initiative.The organisational chart clearly shows independence of QA/QC from production manager which is inaccordance with ICH Q7. The people breakdown is 62 for production, 7 for QA/QC and 1 for HSE.The major products manufactured are benzene sulfonyl chloride ( around 100T/year ) andparachlorobenzene sulfonyl chloride ( around 100T/year ).3 people are dedicated to Process Development for this unit ( 25 people are working in Process

D l t t t th 8 l t l t d i th )




Audit Report

Page 6 of 12


Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004

10. SITE TOURDue to time constraints the site tour was focused on critical areas.The room dedicated to the “flaker” system was inspected and found adequate. The system wasacquired in October 2010 and specially designed for this operation. The feeding rate is around 200to 250 Kg/hour and the operation is performed under nitrogen to avoid potential hydrolysis of theproduct. The room is regularly cleaned and the “flaker” cleaned during maintenance shut down( twice a year ).

Observation ( minor ) : SOPs designed to cleaning should be available in the room for potential check ( these procedures were not check during documentation review ).Raw Material warehouse : all the raw materials used are mainly liquids and stored in dedicated andproperly labelled tanks. All the goods are delivered by trucks and analyses performed on a samplefrom the truck and from the tank itself which is a good practice. The remaining stock is checked on aregular basis. The flexibles are dedicated to each product and protected with plastic covers which isa good practice too.Only accepted solid raw materials are stored in the plant because trucks are unloaded only if productis found within specifications. Labelling was found adequate.

Finished products warehouse : it was found clean and well organized with identified zones. All theproducts were clearly labelled. PE bags and liners are stored in a specific area and identified with abatch number which is a good practice ( batches N° PM/11/147 and PM/11/141 ).QC tour : main instruments used are 2GC, 1GC/HS and 1 LC, they are quite new.GC calibration are performed in house twice a year using a mixture of benzene, toluene and xyleneto test accuracy and linearity.Observation ( minor ) : use of benzene should be limited ( even at lab scale ) for personnelsafety.Maintenance is subcontracted and performed once a year, main parameters checked are oven,

i j t d t t i t f d d t




Audit Report

Page 7 of 12


Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004

In the case of the preceding changes no date of closure ( approval or rejection ) were indicatedneither of formal implementation on site.Management of deviations ( QAP/51 ) and OOS ( QCP/10 ) reviewed and found adequate.

12. APPENDICES

12.1. Appendix 1: Agenda

Audit Team: Auditor 1 J Saint-Germain Lead

Aarti Tarapur site

Opening presentation from Site Management

• Presentation of the companyo Presentation of the plant

o Org charts, headcounto Layout of facilities

o Flow of material and personnel

o Products and their manufacture – flow charts




Audit Report

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Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004

Aarti Tarapur site

Auditor 1 Auditor 2

Systems Review• Site Master Plan ( if any )• Documentation (SOP System,

Master Records control andapproval, Document retention andarchiving)

• Management of deviations

• Supplier audits (plan, certification,approved suppliers list)

• Self-inspection program (plan,responsibilities, follow-up)

• Training System Overview(GMP,on the job, specialist training,Training records, Job descriptions)and selected records

• Management of complaints

• Qualification/Validation Program(Overview, and selected equipmentand documentation selected

li )

Systems Review• Annual product review ( if any )• Management of ChangeControl

• Batch records review• Site Quality Management (Roles

and Responsibilities, processflow, release of materials )

• Environmental Monitoring Datafor selected areas (requested

during lab tour)• Cleaning Validation

• Technical Agreements betweensite and suppliers/customers

• Preventive Maintenance andCalibration

• Review of process and processvalidation




Audit Report

Page 9 of 12


Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004




Audit Report

Page 10 of 12


Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004




Audit Report

Page 11 of 12


Audit dates:

12/08/11

Report issue date:

02/01/12

Report Reference :

JSG-11Audit-004




Audit Report

Page 12 of 12


Audit dates:12/08/11

Report issue date:02/01/12

Report Reference :JSG-11Audit-004

13. ADDENDUM

OBSERVATIONS NOTED

No Observations Observation Level Corrective action proposed ProposedCompletion date

acceptance fromlead auditor

acceptanceDate

1. ok

2. ok

3. ok

4. ok

5. ok

6. ok

7. ok

8. ok

9. ok

This report is confidential to sanofi-aventis

Page 12 of 12

Audit Report for : Report Ref: JSG-11Audit-004 Date of Audit: 12/08/11

AuditReportAarti_Tarapur[1]

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