Hola Y Chau

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© World Health Organization
WHO Technical Report Series, No. 961, 2011

Annex 3 WHO good manufacturing practices for pharmaceutical products: main principles
Introduction General considerations Glossary Quality management in the medicines industry: philosophy and essential elements 1. 2. 3. 4. 5. 6. 7. Quality assurance Product quality review Good manufacturing practices for pharmaceuticalproducts Sanitation and hygiene Qualification and validation Complaints Product recalls Contract production and analysis General The contract giver The contract accepter The contract Self-inspection, quality audits and supplier’s audits and approval Items for self-inspection Self-inspection team Frequency of self-inspection Self-inspection report Follow-up action Quality audit Suppliers’ audits andapproval Personnel General Key personnel

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10. Training 11. Personal hygiene
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12. Premises General Ancillary areas Storage areas Weighing areas Production areas Quality control areas 13. Equipment 14. Materials General Starting materials Packaging materials Intermediate and bulk products Finished products Rejected, recovered, reprocessed and reworked materials Recalled productsReturned goods Reagents and culture media Reference standards Waste materials Miscellaneous 15. Documentation General Documents required 16. Good practices in production General Prevention of cross-contamination and bacterial contamination during production Processing operations Packaging operations 17. Good practices in quality control Control of starting materials and intermediate, bulk andfinished products Test requirements Batch record review Stability studies References

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Introduction
The first WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth World Health Assembly (resolution WHA20.34). It was subsequently submitted to the Twenty-first World Health Assembly under the title “Draft requirements forgood manufacturing practice in the manufacture and quality control of medicines and pharmaceutical specialities” and was accepted. The revised text was discussed by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in 1968 and published as an annex to its twenty-second report. The text was then reproduced (with some revisions) in 1971 in the Supplement to the second editionof The International Pharmacopoeia. In 1969, when the World Health Assembly recommended the first version of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce in resolution WHA22.50, it accepted at the same time the GMP text as an integral part of the Scheme. Revised versions of both the Certification Scheme and the GMP text were adopted in 1975by resolution WHA28.65. Since then, the Certification Scheme has been extended to include the certification of: — veterinary products administered to food-producing animals; — starting materials for use in dosage forms, when they are subject to control by legislation in both the exporting Member State and the importing Member State; — information on safety and efficacy (resolution WHA41.18, 1988). In1992, the revised draft requirements for GMP were presented in three parts, of which only Parts One and Two are reproduced in this document (1). “Quality management in the medicines industry: philosophy and essential elements”, outlines the general concepts of quality assurance (QA) as well as the principal components or subsystems of GMP, which are joint responsibilities of top management and ofproduction and quality control management. These include hygiene, validation, self-inspection, personnel, premises, equipment, materials and documentation. “Good practices in production and quality control”, provides guidance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of QA. These two parts were subsequently...
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