Skip to main content
SpringerLink
Log in

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

  • Wetenschappelijke Mededelingen
  • Published:
Pharmaceutisch weekblad Aims and scope Submit manuscript

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.

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  • 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).

Download references

Author information

Authors and Affiliations

  1. Pharmaceutische Ontwikkelings Afdeling, Philips-Duphar bv, C. J. van Houtenlaan 36, Weesp, The Netherlands

    A. A. van Dooren

Authors
  1. A. A. van Dooren
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

van Dooren, A.A. The adaptation of a small-scale production unit to current GMP-rules. Pharmaceutisch Weekblad Scientific Edition 1, 273–281 (1979). https://doi.org/10.1007/BF02293204

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF02293204

Keywords

Search

Navigation