HAZARD ANALYSIS & CRTICAL CONTROL POINTS:
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:
[COLOR=“royalblue”]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 [/color]
*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.
The HACCP methodology aims to prevent known hazards and reduce the risk that they will occur at specific points in the pharmaceutical manufacturing processes. It covers both the Good Manufacturing Practices (GMP) and the safety of the personnel engaged in the manufacturing processes. The problems associated with the implementation of HACCP may be overcome by training and education in the HACCP system for the personnel engaged in pharmaceutical industry. The HACCP system benefits all, the consumers, industry and the government as it focuses on prevention rather than relying mainly on end product testing.