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Annexes
Annex 1 Manufacture of sterile medicinal products Annex 2 Manufacture of biological medicinal products for human use Annex 3 Manufacture of radiopharmaceuticals Annex 4 Manufacture of veterinary medicinal products other than immunologicals Annex 5 Manufacture of immunological veterinary medical products Annex 6 Manufacture of medicinal gases Annex 7 Manufacture of herbal medicinal products Annex 8 Sampling of staring and packaging materials Annex 9 Manufacture of liquids, creams and ointments
Annexes
Annex 10 Manufacture of pressurised metered dose aerosol preparations for inhalation Annex 11 Computerised systems Annex 12 Use of ionising radiation in the manufacture of medicinal products Annex 13 Manufacture of investigational medicinal products Annex 14 Manufacture of products derived from human blood or human plasma Annex 15 Oualification and validaiton Annex 16 (Quaified person and batch release) Annex 17 Parametric release Annex 18 GMP Guide for active pharmaceutical ingredients
CHAPTER 2 PERSONNEL
The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded.
CHAPTER 2 PERSONNEL
All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs
CHAPTER 4 DOCUMENTATION
Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instruction, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance.
CHAPTER 5 PRODUCTION
Production operations must follow clearly defined procedures; they must comply with the principles of Good Manufacturing Practice in order to obtain products of the requisite quality and be in accordance with the relevant manufacturing and marketing authorizations.
Introduction General considerations Glossary Quality management in the drug industry: philosophy and essential elements 1. Quality assurance 2. Good manufacturing practices for pharmaceutical products (GMP) 3. Sanitation and hygiene