Indian pharmaceutical industry is becoming global at high pace. This resulted in high pressure on the industry for quality products and practices. Thus cGMP has acclaimed Key position.Practicing cGMP requires clear understanding at conceptual and implementation level and that too at shop floor and middle management level. This book is written in simple and easy to implement manner.
Salient features
All current issues of cGMP demanded by regulatory authorities like W.H.O. M.H.R.A., T.G.A., U.S.F.D.A, and also Indian F.D.A. are fully discussed, profusely referenced and thoroughly illustrated in simple and easy to understand language.Covers other important topics like, plant, site security, environmental issues, distribution of products, and preparing for the regulatory audits etc.
Contents:1. Personnel2. Surroundings, Buildings and Facilities3.
Equipment4. Materials Management5. Quality Management6.
Manufacturing Operations and Control7.
Documentation and Records8.
Pharmaceutical Validation9.
Outsourcing10. Post-Operational Activities11. Sterile Pharmaceutical Products12. Site and Plant Security13. Safety and Environmental Protection14. Good Pharmaceutical Wholesaling Practice15. Pharmaceutical Audits16. An Overview of Quality by Design
About the Authors:
Manohar A. Potdar, M. Pharm, PhD (Production Management) USA is Professor Emeritus of Pharmaceutical Sciences at Poona College of Pharmacy, Bharati Vidyapeeth University, Pune. He teaches undergraduates and postgraduate courses on Pharmaceutical Technology, Plant design and Operation and Quality Assurance Techniques. Guides research students in the field of Pharmaceutical Validation, Quality Assurance, Plant Design etc.He has more than 35 years of Industrial experience gained from Indian and Multinational firms like, Hoechst, Boehringer-Knoll, Burroughs Wellcome, Ranbaxy, Lupin, Wockhardt, Plethico, Cadila and Alkem, He has handled various responsibilities in the area of Q.C./Q.A., Production, Project Management besides executing International Regulatory Audits of WHO, TGA, MHRA, MCC and USFDA. With his Postgraduate Diploma in Training and Development from I.S.T.D. (India) background, he has actively participated in many industrial training programmes.He is a Member and Chairperson for many International Seminars on R.F.I.D applications in Pharmaceutical Industry. Please browse his website: www.cgmp.co.in for complete particulars.
Ramkumar Dubey is a young pharmacist, working in Formulation Analytical R&D at Sun Pharmaceutical Industries Ltd., Vadodara. He holds M. Pharm. Degree (QAT, Poona College of Pharmacy) and Ph.D. (Pharmaceutical Sciences, Birla Institute of Technology, Mesra). He is having more than 5 Years of experience in Q.A., Analytical R&D and DMPK research. He did quality improvement and cost reduction projects for Pharmaceutical Industries under the supervision of Moanohar A. Potdar. He has published 12 International Research articles in the field of Analytical R&D and DMPK research. He is also guiding students for competitive exam like GATE / GPAT / NET.
Salient features
All current issues of cGMP demanded by regulatory authorities like W.H.O. M.H.R.A., T.G.A., U.S.F.D.A, and also Indian F.D.A. are fully discussed, profusely referenced and thoroughly illustrated in simple and easy to understand language.Covers other important topics like, plant, site security, environmental issues, distribution of products, and preparing for the regulatory audits etc.
Contents:1. Personnel2. Surroundings, Buildings and Facilities3.
Equipment4. Materials Management5. Quality Management6.
Manufacturing Operations and Control7.
Documentation and Records8.
Pharmaceutical Validation9.
Outsourcing10. Post-Operational Activities11. Sterile Pharmaceutical Products12. Site and Plant Security13. Safety and Environmental Protection14. Good Pharmaceutical Wholesaling Practice15. Pharmaceutical Audits16. An Overview of Quality by Design
About the Authors:
Manohar A. Potdar, M. Pharm, PhD (Production Management) USA is Professor Emeritus of Pharmaceutical Sciences at Poona College of Pharmacy, Bharati Vidyapeeth University, Pune. He teaches undergraduates and postgraduate courses on Pharmaceutical Technology, Plant design and Operation and Quality Assurance Techniques. Guides research students in the field of Pharmaceutical Validation, Quality Assurance, Plant Design etc.He has more than 35 years of Industrial experience gained from Indian and Multinational firms like, Hoechst, Boehringer-Knoll, Burroughs Wellcome, Ranbaxy, Lupin, Wockhardt, Plethico, Cadila and Alkem, He has handled various responsibilities in the area of Q.C./Q.A., Production, Project Management besides executing International Regulatory Audits of WHO, TGA, MHRA, MCC and USFDA. With his Postgraduate Diploma in Training and Development from I.S.T.D. (India) background, he has actively participated in many industrial training programmes.He is a Member and Chairperson for many International Seminars on R.F.I.D applications in Pharmaceutical Industry. Please browse his website: www.cgmp.co.in for complete particulars.
Ramkumar Dubey is a young pharmacist, working in Formulation Analytical R&D at Sun Pharmaceutical Industries Ltd., Vadodara. He holds M. Pharm. Degree (QAT, Poona College of Pharmacy) and Ph.D. (Pharmaceutical Sciences, Birla Institute of Technology, Mesra). He is having more than 5 Years of experience in Q.A., Analytical R&D and DMPK research. He did quality improvement and cost reduction projects for Pharmaceutical Industries under the supervision of Moanohar A. Potdar. He has published 12 International Research articles in the field of Analytical R&D and DMPK research. He is also guiding students for competitive exam like GATE / GPAT / NET.
