Quality Assurance Compliance: Procedures for Pharmaceutical and Biotechnology Manufacturers
Author:   Ira C. Peine (Magid-Hassner Associates, Alexandria, Virginia, USA)
Publisher:   Taylor & Francis Inc
ISBN:  

9780935184518


Pages:   288
Publication Date:   01 February 1994
Format:   Hardback
Availability:   Awaiting stock   Availability explained


Our Price $605.33 Quantity:  
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Quality Assurance Compliance: Procedures for Pharmaceutical and Biotechnology Manufacturers


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Overview

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.

Full Product Details

Author:   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:  

9780935184518


ISBN 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   Availability explained

Table of Contents

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.

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