2 options
Quality assurance of pharmaceuticals : a compendium of guidelines and related materials. Volume 2, Good manufacturing practices and inspection.
- Format:
- Book
- Government document
- Language:
- English
- Subjects (All):
- Pharmaceutical industry--Quality control.
- Pharmaceutical industry.
- Drugs--Inspection.
- Drugs.
- Physical Description:
- 1 online resource (413 p.)
- Edition:
- 2nd updated ed.
- Other Title:
- Good manufacturing practices and inspection
- Place of Publication:
- Geneva : World Health Organization, c2007.
- Language Note:
- English
- Summary:
- Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control, and in the pharmaceutical industry.
- Contents:
- Introduction
- 1. WHO good manufacturing practices : main principles for pharmaceutical products
- 2. WHO good manufacturing practices : starting materials
- 3. WHO good manufacturing practices : specific pharmaceutical products
- 4. Inspection
- 5. Hazard and risk analysis in pharmaceutical products
- 6. Sampling operations.
- Notes:
- Description based upon print version of record.
- Includes bibliographical references and index.
- ISBN:
- 1-281-30738-6
- 9786611307387
- 92-4-068248-1
- OCLC:
- 476127815
The Penn Libraries is committed to describing library materials using current, accurate, and responsible language. If you discover outdated or inaccurate language, please fill out this feedback form to report it and suggest alternative language.