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Soft cover. Zustand: New. Contents Preface I Guidelines in Pharmaceuticals 1 Introduction to Clinical Pharmacy 2 Audit Guide Line formats for pharmaceutical excipients 3 Good Laboratory practices 4 Good clinical practice guidelines 5 Hazard and risk analysis in pharmaceutical products 6 Validation Protocols 7 Pharmaceutical Inspections II Regulations in Pharmaceuticals 8 The Consumer Protection Act 1986 9 The Environment Protection Act 1986 10 Scale up and Post Approval Changes III Quality Management in Pharmaceuticals 11 Quality Management System for API?s GMP and ISO 12 Process Analytical Technology 13 Quality Risk Management 14 Quality Management of Cosmetics Bibliography IndexThe global market associated with pharmaceuticals has progressed enormously since last few decades The quality and economy of a pharmaceutical product became an essential aspect for its existence and fulfillment of global requirements It is also a concern for various regulatory agencies all over the world Pharmaceutical manufacturer has to produce the products that meet the prescribed standards of certain international regulatory agencies and local government These agencies provide guidelines and set various regulations for the pharmaceutical manufacturers to get quality products In concern with all these facts quality assurance and quality management became a specialized area of study that deals with the practices to be adopted during the manufacturing of pharmaceuticals This book deals with all the elements of quality assurance and managementSalient Features Presented the information in condensed cohesive form Covers different validation protocols for various processes methods and equipments involved in the manufacturing Involved pharmaceutical inspections various regulatory acts Explained the quality management system and its role 562 pp.

Hardbound. Zustand: As New. New. Contents Preface. 1. Pharmaceutical packaging and design. 2. Packaging materials. 3. Polymers and plastics in packaging. 4. Glass as a packaging material. 5. Metals in packaging. 6. Blister and strip packages. 7. Quality control in packaging. 8. Defects in packaging. 9. Stability of packages. 10. Ancillary materials used in packaging. 11. Sterilization of packaging. 12. Packaging of parenterals ophthalmic and aerosols. 13. Corrugated Fiberboard and cartons. 14. Labelling of pharmaceutical packages. 15. Regulatory aspect of pharmaceutical packaging. Appendix. Index. Packaging technology has become a separate subject in pharmaceutical sciences due to its vital applications in preserving therapeutic efficacy of drugs. The subject was less understood earlier due to non availability of complete information. This book presents detailed account in the form of a specialized book on the subject. Blisters and strips packaging are of growing importance and so a chapter is included on this topic. Parenteral and ophthalmic products need sterilized packaging therefore a chapter covering unique features for sterilizing packaging materials has been included. A new chapter on regulatory aspects of pharmaceutical packaging has also been added. Salient features Each chapter is arranged to facilitate the effortless flow of information in simple motivating and commonsensical approach. Detailed physico chemical information on raw material e.g. glass plastic polymers metals etc. used in pharmaceutical packaging is presented. More informative emphasize has been made on pharmaceutical packaging design based on characteristic properties of materials used in packaging. A chapter on quality control and stability testing of packages explains the shelf life concern aspects of the Active Pharmaceutical Ingredient (API). 280 pp.

Zustand: New. In.