WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report: Annex 3 - Good manufacturing practices for biological products 1 : 6. Production

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages)

Table of Contents

	WHO Expert Committee on Specifications for Pharmaceutical Preparations
	1. Introduction
	2. The international pharmacopoeia and related activities
		2.1. Quality specifications for drug substances and dosage forms
		2.2. Dissolution test for solid oral dosage forms: paddle method
		2.3. Therapeutic equivalence of multisource products
		2.4. International nonproprietary names for pharmaceutical substances
	3. International Chemical Reference Substances and International Infrared Reference Spectra
		3.1. Establishment of reference substances
		3.2. Infrared reference spectra
	4. Quality control methods for medicinal plant materials
	5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
	6. Good manufacturing practices for pharmaceutical products
		6.1. Biological products
		6.2. Herbal medicinal products
		6.3. Process validation
		6.4. Further developments
	7. Development of globally acceptable standards for excipients
	8. Stability of dosage forms
		8.1. Survey
		8.2. Guidelines on stability testing of pharmaceutical products containing established drug substances
	9. Simple test methodology
	10. Quality assurance in pharmaceutical supply systems
	11. Pharmaceutical production in developing countries
		11.1. Small-scale preparation of ophthalmic (eye) drops
		11.2. Production of hormonal contraceptives
	12. Training
	Acknowledgements
	References
	Annex 1 - List of available International Chemical Reference Substances¹
	Annex 2 - List of available International Infrared Reference Spectra
	Annex 3 - Good manufacturing practices for biological products¹
		1. Scope of these guidelines
		2. Principles
		3. Personnel
		4. Premises and equipment
		5. Animal quarters and care¹
		6. Production
		7. Labelling
		8. Lot processing records (protocols) and distribution records
		9. Quality assurance and quality control
		Authors
		Acknowledgements
		References
	Back Cover

6. Production

6.1 Standard operating procedures shall be available and maintained up to date for all manufacturing operations.

6.2 Specifications for starting materials should include details of their source, origin and method of manufacture and of the controls applied, in particular microbiological controls, to ensure their suitability for use. Release of a finished product is conditional on satisfactory results being obtained in the tests on starting materials.

6.3 Media and cultures shall be added to fermenters and other vessels under carefully controlled conditions to avoid contamination. Care shall be taken to ensure that vessels are correctly connected when cultures are added.

6.4 If possible, media should be sterilized in situ. In-line sterilizing filters for routine addition of gases, media, acids, alkalis, defoaming agents, etc. to fermenters should be used where possible.

6.5 Careful consideration should be given to the validation of sterilization methods.

6.6 When an inactivation process is performed during manufacture, measures should be taken to avoid the risk of cross-contamination between treated and untreated products.

6.7 A wide variety of equipment is used for chromatography; in general such equipment should be dedicated to the purification of one product and should be sterilized or sanitized between batches. Problems of decontamination and purification may arise through repeated use of the same equipment at the same or different stages of processing. The life span of columns and the sterilization method shall be defined. Particular care should be given to monitoring microbial loads and endotoxins.