HACCP - getting closer and closer

GMP News No 106

GMP News
6 April 2001

HACCP – getting closer and closer

We already reported on HACCP in GMP News on May 27, 1999. Since the developments in this area are making such rapid progress we would like to take this opportunity to inform you about the current developments.

At the end of 2000 PDA (Parenteral and Drug Association) held a seminar on the topic of Hazard Analysis and Critical Control Points (HACCP) in order to familiarize the pharmaceutical industry with this concept.

Historically HACCP is a management tool for the food-processing industry for the identification, evaluation and control of hazards.

Since 1973 FDA has made the HACCP concept a firm requirement for its canners. In 1997 the seafood-processing industry and in 1998 large meat- and poultry-processing plants were also required by FDA to implement an HACCP concept.
Food-processing plants in Europe must also prove that they employ an HACCP concept.

What is behind HACCP?

The HACCP concept comprises seven stages:

  • Analysis and identification of potential hazards (hazard analysis)
  • Determination of the critical control points*
  • Definition of limits
  • Establishment of a monitoring system
  • Definition of corrective action
  • Ongoing checking of the system (verification)
  • Definition of the type and extent of the documentation
  • *Whereby critical control points are understood as local conditions, activities or procedures subject to regulating intervention in order to reduced or prevent a hazard.

    Every (part) process stage is to be evaluated against the background of each of the seven stages.

    The HACCP concept is not yet compulsory for the manufacture of medicinal products or medical devices.

    Nevertheless FDA, and in particular CDER (Center for Drug Evaluation and Research) and CDRH (Center for Devices and Radiological Health), the two large organizations supervising the manufacture of medicinal products and medical devices, are considering expanding the HACCP concept to include their areas of supervision.

    Since 1998 a pilot study together with CDRH on the application of the HACCP concept among US medical products manufacturers has even been taking place.

    Since early in 2000 already (The Gold Sheet, F-D-C-Reports, May 2000) Field Director Gary Dykstra (CDER) expressed FDA's interest in adopting the HACCP concept in the pharmaceutical industry. Starting with an intensive discussion within FDA one can expect in the near future that the concept will be externalized. Consequently the critical control points and the steering of the manufacturing process will become more the focus of activities in future.

    From the point of view of FDA the HACCP concept provides the inspectors with the opportunity to be able to concentrate on really critical manufacturing activities. For this reason FDA is planning on strengthening its activities in this area.

    Annex 15 of the EC-GMP Guide on validation/ qualification which is to be published this summer will make hazard analysis a standard requirement. One of the possible methods of hazard analysis is the HACCP concept.


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