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
Close this folder12. Premises
View the documentGeneral
View the documentAncillary areas
View the documentStorage areas
View the documentWeighing areas
View the documentProduction areas
View the documentQuality control areas
View the document13. Equipment
Open this folder and view contents14. Materials
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
 
Production areas

12.24 In order to minimize the risk of a serious medical hazard due to cross-contamination, dedicated and self-contained facilities must be available for the production of particular pharmaceutical products, such as highly sensitizing materials (e.g. penicillins) or biological preparations (e.g. live microorganisms). The production of certain other highly active products, such as some antibiotics, hormones, cytotoxic substances and certain non-pharmaceutical products, should not be conducted in the same facilities. In exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary validations (including cleaning validation) are made. The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in premises used for the manufacture of pharmaceutical products.

12.25 Premises should preferably be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels.

12.26 The adequacy of the working and in-process storage space should permit the orderly and logical positioning of equipment and materials so as to minimize the risk of confusion between different pharmaceutical products or their components, to avoid cross-contamination, and to minimize the risk of omission or wrong application of any of the manufacturing or control steps.

12.27 Where starting and primary packaging materials and intermediate or bulk products are exposed to the environment, interior surfaces (walls, floors and ceilings) should be smooth and free from cracks and open joints, should not shed particulate matter, and should permit easy and effective cleaning and, if necessary, disinfection.

12.28 Pipework, light fittings, ventilation points and other services should be designed and sited to avoid the creation of recesses that are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the manufacturing areas.

12.29 Drains should be of adequate size and designed and equipped to prevent back-flow. Open channels should be avoided where possible, but if they are necessary they should be shallow to facilitate cleaning and disinfection.

12.30 Production areas should be effectively ventilated, with air-control facilities (including filtration of air to a sufficient level to prevent contamination and cross-contamination, as well as control of temperature and, where necessary, humidity) appropriate to the products handled, to the operations undertaken and to the external environment. These areas should be regularly monitored during both production and non-production periods to ensure compliance with their design specifications.

12.31 Premises for the packaging of pharmaceutical products should be specifically designed and laid out so as to avoid mix-ups or cross-contamination.

12.32 Production areas should be well lit, particularly where visual on-line controls are carried out.

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