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
Open this folder and view contents14. Materials
Open this folder and view contents15. Documentation
Close this folder16. Good practices in production
View the documentGeneral
View the documentPrevention of cross-contamination and bacterial contamination during production
View the documentProcessing operations
View the documentPackaging operations
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
Processing operations

16.15 Before any processing operation is started, steps should be taken to ensure that the work area and equipment are clean and free from any starting materials, products, product residues, labels or documents not required for the current operation.

16.16 Any necessary in-process controls and environmental controls should be carried out and recorded.

16.17 Means should be instituted of indicating failures of equipment or of services (e.g. water, gas) to equipment. Defective equipment should be withdrawn from use until the defect has been rectified. After use, production equipment should be cleaned without delay according to detailed written procedures and stored under clean and dry conditions in a separate area or in a manner that will prevent contamination.

16.18 Time limits for storage of equipment after cleaning and before use should be stated and based on data.

16.19 Containers for filling should be cleaned before filling. Attention should be given to avoiding and removing any contaminants such as glass fragments and metal particles.

16.20 Any significant deviation from the expected yield should be recorded and investigated.

16.21 Checks should be carried out to ensure that pipelines and other pieces of equipment used for the transportation of products from one area to another are connected in a correct manner.

16.22 Pipes used for conveying distilled or deionized water and, where appropriate, other water pipes should be sanitized and stored according to written procedures that detail the action limits for microbiological contamination and the measures to be taken.

16.23 Measuring, weighing, recording, and control equipment and instruments should be serviced and calibrated at prespecified intervals and records maintained. To ensure satisfactory functioning, instruments should be checked daily or prior to use for performing analytical tests. The date of calibration and servicing and the date when recalibration is due should be clearly indicated, preferably on a label attached to the instrument.

16.24 Repair and maintenance operations should not present any hazard to the quality of the products.

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