Covering key areas of GMP compliance and QA, this text provides sample documentation and systems in use in pharmaceutical, biotechnology, and active pharmaceutical ingredient companies worldwide. Sixty-eight procedures with forms are grouped into eight critical areas: documentation, raw material control, in-process material control, corrective action, deviations and complaints, production cleaning, processing and documentation, QC lab documentation, product quality, and training and health. Fifty-eight forms, reports, and label formats enhance the practicality of the text. Most of the forms presented in the book are included on a diskette in ASCII format.
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Inside This Book
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First Sentence:
All companies that must comply with the FDA regulations are familiar with the phrase "documentation and traceability." Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
storage stability studies, master batch record, status tag, documentation sheet, accelerated stability studies, batch records, retain samples, nonconforming materials, quarantine area, pink copy, receiving department, yellow copy, calibration program, complaint report, complaint system Key Phrases - Capitalized Phrases (CAPs): (learn more)
Application Applies, Material Review Board, Test Request Form, Emergency Deviation Report, Planned Deviation Report, Corrective Action Report, Production Department, Production Director, Nonconforming Material Report, Packaging Department, Equipment Status Tag, Label Control Form, Purchasing Department, Raw Material Inventory Control Card, Production Supervisor, Stability Program, Temperature Recording Control Log, Instrument Use Logbook, Review Committee, Customer Complaint Report Log, Final Product Complaint Report, Material Receiving Form, Production Equipment Cleaning Log, Receiving Log, Associated Materials New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Back Cover | Surprise Me!
All companies that must comply with the FDA regulations are familiar with the phrase "documentation and traceability." Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
storage stability studies, master batch record, status tag, documentation sheet, accelerated stability studies, batch records, retain samples, nonconforming materials, quarantine area, pink copy, receiving department, yellow copy, calibration program, complaint report, complaint system Key Phrases - Capitalized Phrases (CAPs): (learn more)
Application Applies, Material Review Board, Test Request Form, Emergency Deviation Report, Planned Deviation Report, Corrective Action Report, Production Department, Production Director, Nonconforming Material Report, Packaging Department, Equipment Status Tag, Label Control Form, Purchasing Department, Raw Material Inventory Control Card, Production Supervisor, Stability Program, Temperature Recording Control Log, Instrument Use Logbook, Review Committee, Customer Complaint Report Log, Final Product Complaint Report, Material Receiving Form, Production Equipment Cleaning Log, Receiving Log, Associated Materials New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Back Cover | Surprise Me!
Citations (learn more)
This book cites 54
books:
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9
books
cite this book:
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- Public Finance by J. Richard Aronson on page 261, and page 270
- Quality Control (Open Learning for Supervisory Management) by National Examinations Board for Supervisory Studies on page 239, and page 240
- Quality Rules in Active Pharmaceutical Ingredients Manufacture: American Edition (5-pack) by John Sharp in Back Matter
- Good Computer Validation Practices: Common Sense Implementation by Teri Stokes in Back Matter
- Computer Validation Compliance: A Quality Assurance Perspective by Mary Ellen Double in Back Matter
See all 54 books this book cites
- Development and Manufacture of Protein Pharmaceuticals (Pharmaceutical Biotechnology) (Pharmaceutical Biotechnology (closed)) by Steve L. Nail on page 402
- Audit by Mail: Time and Cost Effective GMP Audit Tool by John Lyall in Back Matter
- International Clinical Trials: A Guidebook and Compendium of National Drug Laws, Two-Volume Set by Dominique Brunier in Back Matter
- Computer Validation Compliance: A Quality Assurance Perspective by Mary Ellen Double in Back Matter
- Validation Compliance Biannual by International Validation Forum in Back Matter
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