How to Sell Validatable Equipment to Pharmaceutical Manufacturers
Seiten
1999
Crc Press Inc (Verlag)
978-1-57491-097-1 (ISBN)
Crc Press Inc (Verlag)
978-1-57491-097-1 (ISBN)
Suppliers of pharmaceutical manufacturing equipment must ensure that their equipment is provided to their customers in a validatable state. Written in simple, clear, and concise language that gets past all the regulationese, this book covers the basics of validation, planning process equipment design and construction, documentation requirements, avoiding validation pitfalls, and the types of services the supplier should provide. The book provides insights on how to avoid the costly and time-consuming problem of reworking the equipment to develop the information that is needed to successfully complete their validation package - after the equipment has been delivered and installed. Here in one volume is all the information suppliers and manufacturers need to be able to effectively conduct business in a cost- and time-effective manner.
Key areas of discussion include:
o Validation and GMP issues
o Why validation is so important to pharmaceutical manufacturers
o The role of equipment suppliers in supporting validation
o How validation affects the quality of drugs
o A discussion of the importance of each phase of validation
o Examples of pre-validation work
o Pharmaceutical industry conventions for equipment design
& construction
o Questions to ask about validation, including a checklist
o Regulations in plain language, including the terms and vocabulary
o Computer validation
o Business & cost issues
Key areas of discussion include:
o Validation and GMP issues
o Why validation is so important to pharmaceutical manufacturers
o The role of equipment suppliers in supporting validation
o How validation affects the quality of drugs
o A discussion of the importance of each phase of validation
o Examples of pre-validation work
o Pharmaceutical industry conventions for equipment design
& construction
o Questions to ask about validation, including a checklist
o Regulations in plain language, including the terms and vocabulary
o Computer validation
o Business & cost issues
Erik Kopp (Flemington, New Jersey, USA)
Introduction, 1 The Basics: The Regulations in Plain Language, 2 A (Very) Simple Validation Example, 3 Why Is Validation So Confusing? 4 What to Be Aware of Before Working on a Job for the Pharmaceutical Industry 5 Providing Validatable Equipment: The Role of the Equipment Supplier 6 Pharmaceutical Industry Requirements for Process Equipment Design and Construction 7 Validatable Computer Systems 8 Documentation: The Foundation of Good Manufacturing Practices 9 The Turnover Package 10 Providing Added Value Without a Lot of Extra Work 11 Validation Hang-Ups: What to Watch Out for and How To Avoid Them 12 Validation Services Performed by Equipment Suppliers 13 Conclusion
| Erscheint lt. Verlag | 30.9.1999 |
|---|---|
| Verlagsort | Bosa Roca |
| Sprache | englisch |
| Maße | 210 x 280 mm |
| Gewicht | 840 g |
| Themenwelt | Medizin / Pharmazie ► Allgemeines / Lexika |
| Medizin / Pharmazie ► Pflege | |
| Medizin / Pharmazie ► Pharmazie ► PTA / PKA | |
| Naturwissenschaften ► Biologie | |
| Technik | |
| Wirtschaft | |
| ISBN-10 | 1-57491-097-3 / 1574910973 |
| ISBN-13 | 978-1-57491-097-1 / 9781574910971 |
| Zustand | Neuware |
| Haben Sie eine Frage zum Produkt? |
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