Good manufacturing practices : medicinal products for human and veterinary use

Bibliographic Information

Good manufacturing practices : medicinal products for human and veterinary use

European Commission, Directorate General III - Industry Pharmaceuticals and Cosmetics

(The Rules governing medicinal products in the European Union, v. 4)

Office for Official Publications of the European Communities, 1998

1997 ed

Other Title

Eudralex

Pharmaceutical legislation

Available at  / 9 libraries

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Description and Table of Contents

Description

This guide to medicinal products features chapters headed by a principle of GMP, outlining the Quality Assurance objectives of that chapter and a text which aims to provide sufficient detail for manufacturers to be made aware of essential matters to be considered when implementing the principle.

Table of Contents

  • Directives. Good manufacturing practices. Basic requirements: quality management
  • personnnel
  • premises and equipment
  • documentation
  • production
  • quality control
  • contract manufacture and analysis
  • complaints and product recall
  • self inspection.

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Details

  • NCID
    BA35115352
  • ISBN
    • 9282820297
  • Country Code
    lu
  • Title Language Code
    eng
  • Text Language Code
    eng
  • Place of Publication
    Luxembourg
  • Pages/Volumes
    x, 143 p.
  • Size
    30 cm
  • Parent Bibliography ID
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