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
 
Starting materials

14.7 The purchase of starting materials is an important operation that should involve staff who have a particular and thorough knowledge of the products and suppliers.

14.8 Starting materials should be purchased only from approved suppliers and, where possible, directly from the producer. It is also recommended that the specifications established by the manufacturer for the starting materials be discussed with the suppliers. It is of benefit that all critical aspects of the production and control of the starting material in question, including handling, labelling and packaging requirements as well as complaints and rejection procedures, are contractually agreed between the manufacturer and the supplier.

14.9 For each consignment, the containers should be checked for at least integrity of package and seal and for correspondence between the order, the delivery note, and the supplier’s labels.

14.10 All incoming materials should be checked to ensure that the consignment corresponds to the order. Containers should be cleaned where necessary and labelled, if required, with the prescribed information. Where additional labels are attached to containers, the original information should not be lost.

14.11 Damage to containers and any other problem that might adversely affect the quality of a material should be recorded and reported to the quality control department and investigated.

14.12 If one delivery of material is made up of different batches, each batch must be considered as separate for sampling, testing and release.

14.13 Starting materials in the storage area should be appropriately labelled. Labels should bear at least the following information:

(a) the designated name of the product and the internal code reference where applicable;

(b) the batch number given by the supplier and, on receipt, the control or batch number given by the manufacturer, if any, documented so as to ensure traceability;

(c) the status of the contents (e.g. on quarantine, on test, released, rejected, returned, recalled);

(d) where appropriate, an expiry date or a date beyond which retesting is necessary.


When fully validated computerized storage systems are used, not all of the above information need be in a legible form on the label.

14.14 There should be appropriate procedures or measures to ensure the identity of the contents of each container of starting material. Bulk containers from which samples have been drawn should be identified.

14.15 Only starting materials released by the quality control department and within their shelf-life should be used.

14.16 Starting materials should be dispensed only by designated persons, following a written procedure, to ensure that the correct materials are accurately weighed or measured into clean and properly labelled containers.

14.17 Each dispensed material and its weight or volume should be independently checked and the check recorded.

14.18 Materials dispensed for each batch of the final product should be kept together and conspicuously labelled as such.

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