GMP Industry-wide requirements

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GMP - Same requirements in other hygiene sectors

Even though in some cases very different institutions exist in the three areas of pharmaceuticals, foodstuffs and cosmetics, and thus also different rules apply, there are various similar, even identical, requirements that need to be met. These are for example:

  • traceability,
  • clear product identification,
  • Quality requirements for end products, but also for raw materials and auxiliary materials,
  • qualified personnel (training and education),
  • suitable production facilities and rooms as well
  • Determine, implement and comply with hygiene requirements.

In addition, there are numerous technologies that apply equally to all three product areas. Whether this concerns closed apparatus or machine forms, predominantly in high-quality stainless steel design, or "well-cleanable" systems, which are executed in Hygienic Design, or even clean-room versions in areas with open product handling - there are numerous parallels and overlaps. The example of hygiene can explain this connection quite well. If, for example, the definitions of hygiene from central regulations in the three areas of pharmaceuticals, food and cosmetics are considered, there are fundamental parallels.
The following basic features of one - let's call it "good hygiene practice" - must be consistently considered in all critical areas of pharmaceutical, food and cosmetic productions alike. This includes

  • not eating, drinking, smoking in the production area;
  • avoid direct contact with the product;
  • Avoid personal items (jewelry or similar);
  • maintain personal hygiene (hand washing);
  • do not introduce pathogens into the product;
  • regular cleaning of production areas;
  • Protection against vermin.

Despite the sometimes very different products pharmaceuticals, foodstuffs and cosmetics, all three areas have one thing in common, the basic idea of ​​GMP, namely the greatest possible consumer protection.

decision-makers-facts

  • In Germany, the production of pharmaceuticals is regulated by the German Medicines Act (AMG).
  • Further implementation can be found in the legally binding Drug and Active Ingredient Production Regulation (AMWHV), which has been in force since 6 September 2006 and supersedes the previous Operating Regulation for Pharmaceutical Entrepreneurs (PharmBetrV).
  • At European level, Directive 91/356 / EEC derives the so-called EC GMP Guide, the EU's GMP Foundations.

Central innovations from the "food hygiene" package of the EC are (national law since 1 January 2006)

  • Merging food and feed,
  • Introduction of a central food control,
  • Stricter labeling and traceability requirements and
  • increased demands on primary production (starting and auxiliary materials),
  • in force in Germany since mid-2007: AVV Lebensmittelhygiene and the "Implementing Regulation" on food hygiene law.

In the cosmetics sector, consumer protection has been further strengthened in line with the trend in pharmaceutical and food products. The supplements essentially concern

  • Identification information (contents and shelf life) and
  • Prohibition of certain components (for example carcinogenic).