New dcgi 2014 final

• 1. Welcome to Holden Medical Laboratories Your Choice for Better Health

2. A pharmaceutical formulation unit engaged in manufacturing of solid dosage forms:tablets and capsules for domestic as well as for Export. Presently we export our products to different countries like Netherlands,Nigeria,Myanmar, Bhutan,& Tazakistan.Our product range includes : 1.Antibiotics like azithromycin,erythromycin,clarithromycin,ciprofloxacin,norfloxacin ofloxacin tablets 2.Drugs used in hyper tension such as captopril,Lisinopril,diltiazem hydrochloride atenolol,metoprolol tartarate tablets. 3.Antituberculosis drugs like ethambutol hydrochloride,isoniazide,pyrazinamide tablets 4.Anthelmintic drugs like praziquantel,Albendazole,mebendazole tablets 5.Drugs into the treatment of Dyspepsia,pepticulcer like omeprazole, lansoprazol capsules,ranitidine hydrochloride tablets HOLDEN MEDICAL LABORATORIES PVT. LTD. Site Address: C-35/36/37, MIDC. Malegaon, Sinnar. Nashik-422 113. INDIA. Your Choice for Better Health 3. BRIEF INFORMATION OF THE COMPANY Your Choice for Better Health Holden Medical laboratories Pvt.Ltd.is engaged in the Manufacture of medicinal Products since 1996 for domestic and foreign markets. 1 2 3 4 5 6 7 Presently Holden Medical laboratories Pvt.Ltd. Exports most of the products to The Netherlands. From Sinnar Unit. Holden Medical laboratories Pvt.Ltd. having an exclusive set up for the manufacturing of Tablets and Capsules dosage form for local and export market. The factory Site is 25 km away from Nashik city. Holden Medical Laboratories Pvt. Ltd. has established the Quality of its products with strong support from its Formulation and Development department. A team comprised of qualified technical people from various disciplines and pharmacists are working towards the objective of continual improvement in Quality of products and adherence of cGMP norms. The regulatory affairs of the company are governed by the legal preview of Indian Drug and Cosmetics Act 1940 and the rules there under. 4. BRIEF INFORMATION OF THE COMPANY Your Choice for Better Health Holden Medical Laboratories Pvt. Ltd. has been approved by the national/ local licensing authority, The Joint commissioner, food & Drugs Administration Nasik (Nasik Division), Maharashtra state, India, for the manufacture of drugs products, under License No. NKD/34 & NKD/19 valid up to 31/12/2016. 8 9 10 11 The facility is designed for tablet and capsules dosage form. No toxic or hazardous substances are handled or manufactured at the site. All the tablets and capsules formulations manufactured at Holden medical Laboratories Pvt. Ltd. are meant for human use only. For Blister Packing: 4992 Lakh tablets/Annum For strip Packing: 1872 Lakh tablets /Annum For Bulk packing: 43.2 Crore tablets /Annum Our Production capacity is as following :12 5. Your own footer Your Logo Name and address of the administrative office: Holden Medical Laboratories Pvt. Ltd WI-FI Park, 6th Floor, Opp. App Lab, Wagle Estate,Thane (w) - 400604 Tel - 91 22 25828764 / 25828034 Fax - 022 25828034 Solid dosage form (Tablets and Capsules) Type of Formulations at the site Your Choice for Better Health 6. Your own footer Your Logo Holden Medical Laboratories Pvt. Ltd. C35/36/37, M.I.D.C. Malegaon, Sinnar. Nashik-422113, INDIA Tel.: 0091 2551 230590/ 92/ 95, Fax.:0091 2551 230593 E-mail: [email protected] Contact Person: Mr. S.W.Kolhatkar Tel.:0091 22 2172 1136/ 1474/1498, Fax: 0091 22 2172 1162 E-mail:[email protected], [email protected] Mobile +919673337139 Name and address of the site, including telephone, fax numbers. Your Choice for Better Health 7. SHORT DESCRIPTION OF THE SITE. The details of the constructed area are provided below Type of building: All concrete with reinforced Cement concrete slabs. 1697.210 sq. meters Total Administration Utility/Engineering QA/QC RM/PM stores FG Stores/BSR Packaging area Production area 70.79 sq. meters 460 sq. meters 300.00 sq. meters 298.04 sq. meters 75.00 sq. meters 161.78sq. meters 331.60 sq. meters 8. SHORT DESCRIPTION OF THE SITE. There are no polluting industries and open drains surrounding the site. Surroundings.: The site is surrounded by East: Open space. West: Bidar Engineering. South: Arona springs. North: Swami Samarth Pins. Your Choice for Better Health 9. Site Map HOLDEN MEDICAL LABORATORIES PVT. LTD. Site Address: C-35/36/37, MIDC. Malegaon, Sinnar. Nashik-422 113. INDIA. 10. The building is constructed in Reinforced Cement Concrete (RCC) frame structure and brick masonry structure with smooth finished walls from inside and finishes on exterior surface. The flooring of stores, secondary packaging, Quality Control and ancillary areas is of polished, smooth stone. Sr.no Environment Preventive measures taken 1. Air A/C/system is installed with pre filter, AHU installed in all different areas to take care of natural or industrial pollution. 2. Land The pollution due to land fill of litters and chemicalsis taken care by robust building construction, free from water seepage and infestation from insects rodents and other animals through pest control. and well drained facilities. 3. Weather By painting external walls. Dehumidifier based on cooling effect on absorption properties of a hygroscopic chemical to protect -humidity sensitive materials -production process wherever necessary 4. Flood threat Construction of building is executed above the anticipated flood level. -effective drainage system. 5. Water seepage from ground. Water resistant building foundation based on proven construction technique. -effective drainage system. 6. Infestation of insects, rodents, birds and other animals Wire mesh at appropriate places. --pest control. PRIMISES 11. Holden Medical Laboratories Pvt. Ltd. has well designed Quality policy which is authorized by the CEO. The basic principle is the commitment of the people to manufacture and supply pharmaceutical formulation with best Quality standards, to achieve Total Customer Satisfaction of the customers in India and abroad. The company will strive to meet the needs of its customers through Continual Improvement. We plan to achieve this, by strengthening Quality Assurance Concept, imparting training to all employees to carry out FAULTLESS OPERATIONS, improving housekeeping and adopting safety practices. Quality Policy Your Choice for Better Health 12. ORGANIZATION CHART 13. Sr.no. Name of person Qualification Designation Total Experience Section in which approval is obtained 1 Mr. S. W. Kolhatkar M.Pharm CEO 31 Yrs. Tablet, Capsule & Injection manufacturing 2 Mr.J.P. Kanawade B. Pharm Plant Manager. 23 Yrs. Tablet, Capsule, Ointment manufacturing 3 Mrs. A. A. Potdar M. Sc. Q.A. Manager 26 Yrs. Chemical and Instrumentation and Microbiological testing 4 Mr.N.H Chalke B.Sc. QC Manager 21 Yrs Chemical, Instrumentation , Microbiological and Sterility testing 5 Mrs. M. R. Shirsath B. Pharm Asst. Manager QC 11 Yrs. Chemical, Instrumentation & Microbiological testing 6 Mr.B.J. Gunjal B.Sc. Sr. Prod. Executive 18 Yrs. Tablets manufacturing 7 Mr. P.R. Tayade B. Pharm Prod. Executive 5 Yrs Tablets manufacturing 8 Mr.S.S. Dalu. B.Pharm Prod. Officer 2Yr. -------------- 9 Mr. V.N. Taskar B.Pharm Prod. Officer 1 Yr. -------------- 10 Mr. P Ugale 12 th Prod. Supervisor 17 Yrs -------------- 14. Sr.no. Name of person Qualification Designation Total Experience Section in which approval is obtained 11 Mr. G.Kuradhe 12 th Prod. Supervisor 15 Yrs -------------- 12 Mr. S Bhadake M.Pharm F& D Executive 7 Yr -------------- 13 Mr. A.D.Nagpure B. Com Stores Executive 15 Yrs. -------------- 14 Mr. Y.R.Pawar B.Com Stores Officer 06 Months -------------- 15 Mr. A. N. Ambekar M.Sc. QC Officer 6 Yrs. Chemical, Instrumentation analysis 16 Mr.K.Bhagat M. Sc. QC Officer 4 Yrs 2 Months -------------- 17 Mr. G.R Shirsath B.Sc QC Officer 2 Yrs -------------- 18 Mr. B Gunjal M.Sc. QC Officer 1 Months -------------- 19 Mrs. K.S Shirsath B.Sc QC Officer 2Yrs. -------------- 20 Miss. G.V.Ladhe M.Sc. QC Officer 1 Yr. 6Months -------------- 21 Mr. A Ugale M.Sc. QC Officer 1 Yr. -------------- 22 Mr.A.R.Gujrathi B.tech (Chemical) & MBA QA Executive. 8 yrs. -------------- 23 Mr. A.A.Waje M.Sc. QA Officer 2 Yrs.9 months -------------- 15. Sr.no. Name of person Qualification Designation Total Experience Section in which approval is obtained 24 Mr.K.B.Wable M.Sc QA Officer 4Yr.5 Months -------------- 25 Mr. P.T.Baste B.Pharm QA Officer 4 months -------------- 26 Miss. Sheetal Rayate B. Pharm QA Officer 1 Yr.10 Months -------------- 27 Mr.S.R.Chavan M.Pharm IPQA Officer 1Yr.4 Months -------------- 28 Mrs.S.R.Nawale B.pharm.MBA QA Officer 6 Months 29 Mr.G.Raut. B.Pharm IPQA Officer 1 Month -------------- 30 Mr.Manoj Prajapati D.E.E. MTN. Officer 3 Yrs. -------------- 31 Mr.J.Arote ITI (Electrician) MTN. Officer 7 Yrs -------------- 32 Mr.V.Kadbhane B. Com Purchase Officer 1 Yrs. -------------- 33 Mr.Datta.Dokphode Diploma in Office Automation IT/EDP Officer 6Yrs. -------------- 34. Mr. N.S. Avhad B. Pharm Reg. Officer 1 Month 35. Mr. D.N. Borade B. Pharm Reg. Officer 1 Month 24. Mr. P.S.Salunke M.Sc. QC Officer 4 Months -------------- 25. Mr . P. B.Pawar M.Sc. QC Officer 4 Months -------------- 16. Quality Motivation: Program to motivate personnel to improve quality & productivity are utilized Process Capabilities: The products are produced so that they conform to the product specifications this is achieved through utilization of validated systems, processes & equipments. Acceptance Sampling :Acceptance sampling is followed and is based on a systematic plan that prescribe how to sample raw materials / finished products, which plays a major role to bring the product up to the desired product quality level. Operating System : The operating systems are designed to have minimum variation on account of people, materials, machines through critically selected vendors of raw / packing materials, standard operating procedures (SOPs) and standard test procedures specification limits & documented for every product & the products conforming to these specification only are released for distribution / sale by the Q.A department. Quality Management System 1 2 3 4 The quality management system involves the following key aspects. Your Choice for Better Health 17. Training Records Training need identification Training calendar GMP Training record. Individual training card. TRAINING RECORDS 18. Holden Medical Laboratories Pvt. Ltd. makes a sincere endeavor to effectively train the personnel to the optimum advantage to the companys growth in terms of quality and quantity. Training is provided based on the companys goals, priorities and changes in the technologies and new induction programmers are conducted as per the current Good Manufacturing Practices . All staff i.e. staff from production, quality assurance, quality control, maintenance, servicing and cleaning - involved in various operations is imparted training at specific predetermined intervals of time. The training aspect not only covers specific tasks but also Good Manufacturing Practices. Training is imparted by able trainers who are experts in the field. Documented evidence of the relevant experience and training of personnel is maintained. 19. SValidationupporting text Supporting text Supporting text Supporting text Supporting text Supporting text THE MAJOR AREAS COVERED FOR TRAINING Handling & Dispensing of Material FDA Rules & Regulations. Prevention of Cross Contamination Basic cGMP Requirements. Importance of GMP & Safety Good Documentation Practices Out of Specifications (OOS) Corrective and Preventive Actions (CAPA) Change control and Deviation. Chemical & Instrumental analysis . Equipment/ Instrument-Operation/Cleaning Procedure. 20. Supporting text Supporting text Supporting text Supporting text Supporting text Supporting text THE MAJOR AREAS COVERED FOR TRAINING Quality Assurance Function. SOPs. Communication & time management Microbiological concepts. Training on HPLC analysis. Validation. Operational training. Sanitation & Personal Health & Hygiene Managerial Skill. The shop floor training is being provided to the workmen by the supervisor and seniors as and when required. 21. Validation Validation ValidationValidation Validation Master Plans Validation Protocols /Reports Validation Field Execution Equipment Qualification Analytical Method Validation(AMV) Cleaning Validation Process Validation Validation of Environmental norms. AHU Validation Water Validation . Your Choice for Better Health HOLDEN MEDICAL LABORATORIES PVT. LTD. Site Address: C-35/36/37, MIDC. Malegaon, Sinnar. Nashik-422 113. INDIA. 22. Documentation as per cGMP cGMP DocumentationQA Your Choice for Better Health HOLDEN MEDICAL LABORATORIES PVT. LTD. Site Address: C-35/36/37, MIDC. Malegaon, Sinnar. Nashik-422 113. INDIA. We Maintain Following documents Site Master File (SMF) Mater validation Plan Validation Records Master Formula Records Batch Manufacturing Records (BMR) Standard Operating Procedures (SOPs) Specifications Deviations & Change Control Records. Out of specification investigation Self Inspection/ internal audits. Complaints and Recalls Stability Records. Vendor Audit s Annual Product Review (APR) 23. Documentation 1 2 3 4 5 There is written procedure for documentation, preparation, approval and distribution of the documents. Documents have identification numbers, Format number, indicating the status of amendment. This helps to maintain traceability of the document throughout the process. The master documents are stored in Quality Assurance department. The master documents are the original documents having sign in blue ink. All the documents are created in a specified format. The title of the document is clearly stated. Documents are prepared by Officer/Executive,approved by department head and authorized by QA Manager. All controlled copies are photocopies of Master copies with a stamp as Distribution copy. Documentation is defined as any procedure, instruction logbook, records, raw data, manuals, and policies associated with the development, manufacture, testing, marketing and distribution of a medicinal product The copies given for Govt. authorities or other agencies are uncontrolled copies.6 Preparation and Approval 24. Documentation 1 2 3 4 5 Distribution and Retrieval: Distribution of all controlled copies of documents done by the Quality assurance department. The uncontrolled copy also stamped in blue ink on top of the first page of document as Uncontrolled Copy All distribution copies (controlled copies) are stamped in blue ink on top right hand corner of the first page of the document as ISSUED BY QA Department. with Signature . The additional copy (controlled or uncontrolled) also issued by QA department. on the request from user department. Only authorized QA person shall retrieve the old version document and ensure that only the current version of the same shall be on the place. The old version of the document shall made OBSOLETE COPY . 25. Documentation 1 2 3 4 5 All Records are stored in secure and protected manner to minimize the potential risk for damage or deterioration. Document related to manufacturing and testing include store documents are retained for 5 years from the date of manufacturing. Master copy of superseding document s are stamped with OBSOLETE COPY .stamp and retained for reference in a separate title. Access control is maintained through lock and key arrangement to the record room . After completion of defined storage period, the record should be withdrawn from document storage system for destruction. The record is destroyed by the authorized person in concern department by tearing the record within premises of company.6 Archival & Destruction: 26. Contract Manufacturing and Testing In addition to in-house expertise, following outside technical assistance has been contracted. This site has own established Quality control (QC) laboratory, but may have to avail at times analytical services from licensed & Govt. approved analytical laboratories in case of any specified test. Contracted Services Few samples are also sent to Approved Public Testing Laboratories where in G.C. & HPLC tests are involved. Following are the testing laboratories identified and qualified for the analytical support. 1. M.J. Lab Pvt. Ltd. A/702, Alica Nagar, Lokhandwala Complex , Kandivali (E), Mumbai-400101. Tel.: 0091 22 2887 5494, 5699 1931, Telefax: 0091 5699 1930 2. Manisha Analytical Laboratories Pvt. Ltd. 135/A, Govt. Industrial Estate, Charkop, Kandivali (W), Mumbai-400067 Tel.: 0091 22 2868 3666, 2869 9888, 2860 2292, Telefax: 2869 5296 3. Neha Analytical Laboratories. Ambad. Nashik-422 113. Phone. No. 0091-9890337547. Some of the Products are manufactured on Contract Manufacturing. Some of the products are manufactured at 1. Relligare Pharmaceuticals, Dindori, Nashik. 3. Sanpras Healthcare Pvt.ltd.Musalgaon, Nashik. 27. List Of Major Equipment's- Production Granulation Vibratory Sifter. Multi Mill. High shear Mixer Granulator.(RMG) Fluid Bed Dryer. Octagonal Blender. Compression/Coating Compression Machine 27 Station. IPQA Equipments Metal Detector Auto coater. Capsule Automatic capsule filling /Polishing / Inspection machine Octagonal Blender 600 Liters Vibratory sifter 30 diameter IPQA Equipments Packaging Blister Pack Machine Strip Pack Machine Alu-Alu Blister pack machine Shrink Pack machine Strapping machine Leak Test machine Conveyer Belts. 28. High Performance liquid Chromatography FTIR Dissolution Apparatus (AutoSampler ESP-124) Autoclave LAF Microscope Incubator List Of Major Equipment's- Quality Control & Quality Assurance Zone Reader Refrigerator Colony counter BOD Incubator Autoclave 21 LTRS. pH/ Conductometer. KF/Potentiometer Humidity control oven(4 nos.) Your Choice for Better Health 29. Melting Point apparatus Muffle Furnace Tablet Hardness tester Vacuum Oven Distilled water plant Vernier Calliper Dissolution test apparatus Polarimeter Spectrophotometer List Of Major Equipment's- Quality Control & Quality Assurance Bulk Density apparatus Single pan balance pH-Meter Refractometer TLC Cabinet Friability test apparatus Disintegration test apparatus Sonication bath (Sonicator) Hot Air Oven Centrifuge Machine Your Choice for Better Health 30. Compression M/C 12 Station Tray Dryer Planetary Mixer Vertical Drive Horizontal Drive Coating Pan Double cone Blender List Of Major Equipments- Steam Boiler (500 Kg/Hr) Effluent Treatment Plant (3000 Liters/Day) Air Compressor (26cfm & 34cfm) Soft Water Plant 300 (Liters/Hr) D.M Water Plant 250 (Liters/Hr) AHU Ventilation system Your Choice for Better Health F&D Maintenance Department 31. DISPENSING OF MATERIAL SIFTING DRY MIXING GRANULATION DRYING IN FBD LUBRICATION COMPRESSION INSPECTION PACKING B. S. R. (FINISHED GOODS STORES) DESPATCH Q. A. CHECK SIZING Q. A. CHECK COATING Q. A. CHECK For Uncoated Tablets Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK 32. DISPENSING OF MATERIAL SIFTING BLENDING CAPSULE FILLING INSPECTION PACKING B. S. R. (FINISHED GOODS STORES) DESPATCH Q. A. CHECK CAPSULE POLISHING Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK Q. A. CHECK 33. Personal hygiene plays an important role in the health of the company. The Head of administration department is responsible to ensure that all the employees undergo a Medical checkup once in a year. There is a system for reporting especially contagious diseases to the department head by the employee, there is also a system of reporting back illness. Adequate facilities are being provided for first aid and medical treatment of workmen and staff. The production personnel wear the approved uniforms only, which include head, face, hand, arm covering and foot covers & secondary gowning & to minimize the potential of cross contamination of the products. The uniforms are regularly laundered and changed. Personnel Hygiene requirements & Clothing 34. THANK YOU! Fresh uniforms are issued to the personnel at the specified periods of time. Facilities including toilets, change rooms, separate lockers are available, for the personnel and these facilities are separated from the production block. . Personnel Hygiene requirements & Clothing Your Choice for Better Health 35. Source of water: Potable water provided by MIDC. Storage facility for: Potable Water: Underground storage Tank: RCC tank with 10,000 liters storage capacity. D. M. Water : Storage Tank: SS 316 tank with 500 liters storage capacity Treatment of potable water: Make : Komal Industries Description : It consists of sand bed, charcoal bed, cation, anion, mixed bed and Ultra filtration facility with UV Tube and circulating loop (SS 316) Capacity : 250 Ltr. /hour. The treated water : The treated water is collected in stainless steel (SS 316) tank with circulating loop and distributed through a piping system. The material of construction of tank and pipelines is SS 316 internally electro polished. Orbital welded pipe joints with triclover fitting and silicon rubber gaskets are used in purified water system 36. text HVAC : Heating Ventilation and Air conditioning system. HVAC system is provided for Granulation , Blending, Compression, Coating, Inspection, Capsule filling. Primary Packing Areas. Fresh air is absorbed through 20 followed by 10 pre inlet filter and then 3 pre out let filter(Fine filter). & Finally it pass through 0.3 HEPA filter Return Air first pass through 10 riser filter and followed by 10 and 3 and finally through 0.3 HEPA filter. For Humidity control provision is made by incorporating suitable heaters. Ventilation system : Ventilation system is provided for all passage and secondary gowning area.Fresh air is absorbed through 10 filter followed by 3 filter and & Finally it pass through plenum 0.3 HEPA filter Where as outlet air is passed through 10 Filter. Reverse Laminar Air Flow System : (RLAF) Reverse Laminar Air Flow System is provided for Sampling & Dispensing area And for Microbial Lab. Reverse air is filtered by 10 filter, followed by 3 filter finally pass through 0.3 . Area like quarantines Split AC is provided, where temperature is maintained below 25 C. At every inlet at the material & Man entry from outside AIR CURTAIN is provided. For Primary packing material storage area and for empty Capsule Storage area separate Split AC is provided. 37. Effluent Treatment Plant is used for the treatment of waste water which is finally used for the garden Effluent Treatment Plant First all the incoming waste water is collected in the screen oil chamber. After that waste water is collected and stored in the equalization tank. By using transfer pump waste water is transferred in the chemical dosing tank. Here adjustment of pH can be done by using Alum solution, Lime solution. And after that it is stored in the conical bottom sludge settling tank. Then drop wise addition of the polyelectrolyte solution is done . Further it is kept for 4-6hour for settling of the sludge. After satisfactions of the settling of sludge open the drain valve & store the sludge in dry bed chamber & upper treated water is transferred to the garden with the help of transfer pump motor. 38. Thank you