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

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.

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