BEST OF THE WEB V.8
For the pharmaceutical technologist
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/cber/guidelines.htm
Guidance for Industry. Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. U.S. Dpt of Health and Human Services – Food and Drug Administration -
Table of contents: I. Introduction. II. Quality Management. III. Personnel. IV. Building and Facilities. V. Process Equipments. VI. Documentation and records. VII. Material Management. VIII. Production and in-process controls. IX. Packaging and identification labelling of APIs and Intermediates. X. Storage and distribution. XI. Laboratory Controls. XII. Validation. XIII. Change control. XIV. Rejection and re-use of materials. XV. Complaints and recalls. XVI. Contract manufacturers. XVII. Agents, brokers, traders, distributors, Re-packers and re-labellers. XVIII. Specific guidance for APIs manufactured by cell culture / fermentation. XIX. APIs for use in clinical trials. X. Glossary.
Note: Q7A means the Expert Working Group of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
For the scientist
Where to find information about the Nobel prizes.
For the medical doctor
News from the world of International Federation of Clinical Chemistry and Laboratory Medicine.
News from the European Federation of Clinical Chemistry and Laboratory Medicine.
