Pharmaceutical Vendors Approval Manual: A Comprehensive Quality Manual for API and Packaging Material...

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Erfan Syed Asif

Pharmaceutical Vendors Approval Manual

A Comprehensive Quality Manual for API and Packaging Material Approval

Erfan Syed Asif

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Paperback

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QTY:

English

CRC Press
29 January 2024

Pharmacology; Biology, life sciences; Engineering: general; Pharmaceutical technology; Environmental science, engineering & technology

This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications.

This book

provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements

covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies

provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry

provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract

Provided material can be easily tailored to incorporate changes to add in-house vendor’s qualification requirements.

Erfan Syed Asif, Ph.

D is a Senior Consultant at PharmEng Technology.

By: Erfan Syed Asif
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 234mm, Width: 156mm,
Weight: 453g
ISBN: 9781032038131
ISBN 10: 1032038136
Pages: 152
Publication Date: 29 January 2024
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.