WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related activities
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Close this folder6. Good manufacturing practices for pharmaceutical products
View the document6.1. Biological products
View the document6.2. Herbal medicinal products
View the document6.3. Process validation
View the document6.4. Further developments
View the document7. Development of globally acceptable standards for excipients
Open this folder and view contents8. Stability of dosage forms
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Open this folder and view contents11. Pharmaceutical production in developing countries
View the document12. Training
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good manufacturing practices for biological products1
View the documentBack Cover

6.1. Biological products

Further to the publication of the revised general text on good manufacturing practices in Annex 1 of the Committee’s previous report (3), it endorsed the guidelines on good manufacturing practices for biological products prepared jointly with the WHO Expert Committee on Biological Standardization (Annex 3). As emphasized in sections 1 and 2 of these additional guidelines, they are to be used only as a supplement to the main text.

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