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

5. Animal quarters and care1

1 General requirements for animal quarters, care and quarantine are given in reference 4.

5.1 Animals are used for the manufacture and control of a number of biological products. Animals shall be accommodated in separate buildings with self-contained ventilation systems. The buildings’ design and construction materials shall permit maintenance in a clean and sanitary condition free from insects and vermin. Facilities for animal care shall include isolation units for quarantine of incoming animals and provision for vermin-free food storage. Provision shall also be made for animal inoculation rooms, which shall be separate from the postmortem rooms. There shall be facilities for the disinfection of cages, if possible by steam, and an incinerator for disposing of waste and of dead animals.

5.2 The health status of animals from which starting materials are derived and of those used for quality control and safety testing should be monitored and recorded. Staff employed in animal quarters must be provided with special clothing, changing facilities and showers. Where monkeys are used for the production or quality control of biological products, special consideration is required, as laid down in the revised Requirements for Biological Substances No. 7 (Requirements for Polio myelitis Vaccine (Oral)) (5).

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