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
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
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
Close this folderAnnex 3 - Good manufacturing practices for biological products1
View the document1. Scope of these guidelines
View the document2. Principles
View the document3. Personnel
View the document4. Premises and equipment
View the document5. Animal quarters and care1
View the document6. Production
View the document7. Labelling
View the document8. Lot processing records (protocols) and distribution records
View the document9. Quality assurance and quality control
View the documentAuthors
View the documentAcknowledgements
View the documentReferences
View the documentBack Cover
 

2. Principles

The manufacture of biological products shall be undertaken in accordance with the basic principles of good manufacturing practices (GMP). The points covered by these guidelines should therefore be considered supplementary to the general requirements set out in “Good manufacturing practices for pharmaceutical products” (1), and relate specifically to the production and control of biological products. In drawing up these guidelines, due consideration was given to the draft “Guidelines for national authorities on quality assurance for biological products”, the final version of which appears as Annex 2 to the forty-second report of the WHO Expert Committee on Biological Standardization (2).

The way in which biological products are produced, controlled and administered makes some particular precautions necessary. Unlike conventional pharmaceutical products, which are normally produced and controlled using reproducible chemical and physical techniques, biological products are manufactured by methods involving biological processes and materials, such as cultivation of cells or extraction of material from living organisms. These processes display inherent variability, so that the range and nature of by-products are variable. For this reason, in the manufacture of biological products full adherence to GMP is necessary for all production steps, beginning with those from which the active ingredients are produced.

Control of biological products nearly always involves biological techniques that have a greater variability than physicochemical determinations. In-process controls take on a great importance in the manufacture of biological products because certain deficiencies may not be revealed by testing the finished product.

The present guidelines do not lay down detailed requirements for specific classes of biological products, and attention is therefore directed to other guidance issued by WHO, and in particular to the Requirements for Biological Substances, which include requirements for vaccines (2, Annex 7).

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