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Quality Assurance Compliance: Procedures for Pharmaceutical and Biotechnology Manufacturers, by Ira C. Peine
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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.
- Sales Rank: #10931487 in Books
- Brand: Brand: CRC Press
- Published on: 1994-02-01
- Original language: English
- Number of items: 1
- Dimensions: 2.19" h x 10.60" w x 11.70" l, 3.70 pounds
- Binding: Hardcover
- 288 pages
- Used Book in Good Condition
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