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
 
Packaging materials

14.19 The purchase, handling and control of primary and printed packaging materials should be as for starting materials.

14.20 Particular attention should be paid to printed packaging materials. They should be stored in secure conditions so as to exclude the possibility of unauthorized access. Roll feed labels should be used wherever possible. Cut labels and other loose printed materials should be stored and transported in separate closed containers so as to avoid mix-ups. Packaging materials should be issued for use only by designated personnel following an approved and documented procedure.

14.21 Each delivery or batch of printed or primary packaging material should be given a specific reference number or identification mark.

14.22 Outdated or obsolete primary packaging material or printed packaging material should be destroyed and its disposal recorded.

14.23 All products and packaging materials to be used should be checked on delivery to the packaging department for quantity, identity and conformity with the packaging instructions.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: August 29, 2014