Product Description
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 Citations: This book cites 54 books | 9 books that cite this book Explore: Citations | Books on Related Topics | Concordance | Text Stats Key Phrases - SIPs: storage stability studies, master batch record, status tag, documentation sheet, accelerated stability studies (more) Key Phrases - CAPs: Application Applies, Material Review Board, Test Request Form, Emergency Deviation Report, Planned Deviation Report (more) Browse Sample Pages: Front Cover | Copyright | Table of Contents | Excerpt | Back Cover | Surprise Me! |
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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 | Copyright | Table of Contents | Excerpt | Back Cover |
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 | Copyright | Table of Contents | Excerpt | Back Cover |