E-DRUG: New WHO publication: Quality Assurance of Pharmaceuticals
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Dear colleagues,
WHO is happy to announce the publication of
Quality Assurance of Pharmaceuticals. Second Edition
A Compendium of Guidelines and Related Materials.
Volume 2: Good Manufacturing Practices and Inspection
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 WHO good
manufacturing practices (GMP) and inspection in one single publication.
This compendium brings it all 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.
Table of contents:
Introduction
1. WHO good manufacturing practices: main principles for pharmaceutical products
Quality management in the drug industry: philosophy and essential elements (update on sampling) (new)
Heating Ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (new)
Validation (new)
Water for pharmaceutical use (new)
2. WHO good manufacturing practices: starting materials
Active pharmaceutical ingredients (bulk drug substances)
Pharmaceutical excipients
3. WHO good manufacturing practices: specific pharmaceutical products
Sterile pharmaceutical products
Biological products
Investigational pharmaceutical products for clinical trials in humans
The manufacture of herbal medicines (updated)
Radiopharmaceutical products
4. Inspection
Pre-approval inspections
Inspection of pharmaceutical manufacturers
Inspection of drug distribution channels
Quality systems requirements for national good manufacturingbpractice inspectorates
Guidance on good manufacturing practices: inspection report
Model certificate of good manufacturing practices
5. Hazard and risk analysis in pharmaceutical products
Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals
6. Sampling operations (new)
Sampling of pharmaceutical products and related materials (new)
Index
ISBN-13 9789241547086
ISBN-10 9241547081
Order Number 11500686
Price CHF 100.00 / US$ 90.00 Developing countries: CHF
70.00
English 2006 453 pages
web-link: Quality Assurance of Pharmaceuticals. Second Edition
<http://www.who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1&co
dcol=15&codcch=686>
With best regards,
Sabine Kopp
Dr Sabine Kopp
Quality Assurance & Safety: Medicines
World Health Organization
20, av. Appia
CH-1211 Geneva 27
Fax: +41 22 791 4730
WHO Medicines Quality Assurance website:
http://www.who.int/medicines/areas/quality_safety/quality_assurance
"Kopp, Sabine" <kopps@who.int>