WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 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. General policy
Open this folder and view contents3. Quality control - specifications and tests
View the document4. Quality control - international reference materials
Open this folder and view contents5. Quality control - national laboratories
Open this folder and view contents6. Quality assurance - good manufacturing practices
Open this folder and view contents7. Quality assurance - inspection
Open this folder and view contents8. Quality assurance - distribution and trade-related
Open this folder and view contents9. Quality assurance - risk analysis
Open this folder and view contents10. Quality assurance - drug supply
Open this folder and view contents11. Quality assurance - storage
View the document12. International Nonproprietary Names (INNs) programme
Open this folder and view contents13. Miscellaneous
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
View the documentAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Open this folder and view contentsAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
Close this folderAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
View the documentIntroduction
View the documentGeneral considerations
View the documentGlossary
Close this folderQuality management in the drug industry: philosophy and essential elements1
View the document1. Quality assurance
View the document2. Good manufacturing practices for pharmaceutical products (GMP)
View the document3. Sanitation and hygiene
View the document4. Qualification and validation
View the document5. Complaints
View the document6. Product recalls
Open this folder and view contents7. Contract production and analysis
Open this folder and view contents8. Self-inspection and quality audits
Open this folder and view contents9. Personnel
View the document10. Training
View the document11. Personal hygiene
Open this folder and view contents12. Premises
View the document13. Equipment
Close this folder14. Materials
View the documentGeneral
View the documentStarting materials
View the documentPackaging materials
View the documentIntermediate and bulk products
View the documentFinished products
View the documentRejected, recovered, reprocessed and reworked materials
View the documentRecalled products
View the documentReturned goods
View the documentReagents and culture media
View the documentReference standards
View the documentWaste materials
View the documentMiscellaneous
Open this folder and view contents15. Documentation
Open this folder and view contents16. Good practices in production
Open this folder and view contents17. Good practices in quality control
View the documentReferences
View the documentAnnex 5 Model certificate of Good Manufacturing Practices
View the documentAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
View the documentAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Open this folder and view contentsAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Open this folder and view contentsAnnex 9 Guide to good storage practices for pharmaceuticals1
View the documentBack cover
 
General

14.3 No materials used for operations such as cleaning, lubrication of equipment and pest control, should come into direct contact with the product. Where possible, such materials should be of a suitable grade (e.g. food grade) to minimize health risks.

14.4 All incoming materials and finished products should be quarantined immediately after receipt or processing, until they are released for use or distribution.

14.5 All materials and products should be stored under the appropriate conditions established by the manufacturer and in an orderly fashion to permit batch segregation and stock rotation by a first-expire, first-out rule.

14.6. Water used in the manufacture of pharmaceutical products should be suitable for its intended use.

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