[indices] new WHO publication: Quality Assurance of Pharmaceuticals

["Kopp, Sabine" <kopps@who.int>]

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 manufacturing
practice 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&;
> codcol=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