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Pharmaceutisch weekblad

, Volume 1, Issue 1, pp 273–281 | Cite as

The adaptation of a small-scale production unit to current GMP-rules

  • A. A. van Dooren
Wetenschappelijke Mededelingen
  • 28 Downloads

Abstract

The reconstruction of a small-scale production facility was designed and carried out in order to:
  1. a.

    conform to current requirements of Good Manufacturing Practices, especially to prevent contamination and mix-ups;

     
  2. b.

    make optimal use of the available area;

     
  3. c.

    provide for the possibility to carry out productions and development work at the same time.

     

The standards for the design and construction of the production rooms are described, and the features of the reconstructed areas are considered in detail.

Keywords

Good Manufacture Practice Solid Dosage Coarse Filter Liquid Dosage Form Production Room 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Samenvatting

Beschreven wordt de verbouwing van een kleinschalige produktie-eenheid welke ten doel had om:
  1. a.

    te voldoen aan de huidige vereisten van Good Manufacturing Practices, speciaal waar het de preventie van contaminatie en verwisseling betreff;

     
  2. b.

    optimaal gebruik te maken van het beschikbare vloeroppervlak;

     
  3. c.

    de mogelijkheid te scheppen om tegelijkertijd produktie-en ontwikkelingsactiviteiten te verrichten.

     

De normen worden beschreven waarvan voor deze verbouwing is uitgegaan. De kenmerken van de diverse ruimten en luchtbehandelingssystemen worden gedetailleerd besproken.

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References

  1. U.S. Food and Drug Administration (1976) Dept. of Health, Education and Welfare, 21 cfr parts 201, 207, 210, 211, 229.Federal Register 41, 6878–6894. U.S. Federal Standard no. 209 B (1973).Google Scholar

Copyright information

© Bohn, Scheltema & Holkema 1979

Authors and Affiliations

  • A. A. van Dooren
    • 1
  1. 1.Pharmaceutische Ontwikkelings AfdelingPhilips-Duphar bvWeespThe Netherlands

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