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Quality Assurance Compliance

Procedures for Pharmaceutical and Biotechnology Manufacturers

Ira C. Peine (Autor)

Buch | Hardcover

288 Seiten

1994
Crc Press Inc (Verlag)
978-0-935184-51-8 (ISBN)

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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.

Typical 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.

Erscheint lt. Verlag	1.2.1994
Sprache	englisch
Maße	216 x 279 mm
Gewicht	1660 g
Themenwelt	Informatik ► Weitere Themen ► Bioinformatik
	Naturwissenschaften ► Biologie ► Genetik / Molekularbiologie
	Naturwissenschaften ► Chemie ► Technische Chemie
	Technik
ISBN-10	0-935184-51-1 / 0935184511
ISBN-13	978-0-935184-51-8 / 9780935184518
Zustand	Neuware