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OverviewCovering 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. Full Product DetailsAuthor: Ira C. Peine (Magid-Hassner Associates, Alexandria, Virginia, USA)Publisher: Taylor & Francis Inc Imprint: CRC Press Inc Dimensions: Width: 21.60cm , Height: 4.40cm , Length: 27.90cm Weight: 1.660kg ISBN: 9780935184518ISBN 10: 0935184511 Pages: 288 Publication Date: 01 February 1994 Audience: Professional and scholarly , College/higher education , General/trade , Professional & Vocational , Postgraduate, Research & Scholarly Format: Hardback Publisher's Status: Out of Stock Indefinitely Availability: Awaiting stock  Table of ContentsTypical procedures include: documentation system, documentation control, vendor approval, raw material bulk sampling, QA label control, in-process sampling, final inspection, testing and acceptance, final product shipping, nonconforming material control, medical device reporting, approval of the production area for use, production batch record issuance control, QC maintenance & calibration, final product review, and training program and documentation.ReviewsAuthor InformationTab Content 6Author Website:Countries AvailableAll regions |
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