Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

HACCP-A description of the risk system and transference in the pharmaceutical industry

Anja Lindau (Abschlußjahr: 2005)

Language : English

This piece of work will show that many elements of the Hazard Analysis of Critical Control Point system (HACCP) can be transferred into the quality system of the pharmaceutical industry. The goal of both areas is to produce safety products.

A quality assurance system that includes the identification of critical process steps and control measures exist in the pharmaceutical industry and food industry. Compliance of this is mandatory. It is very important for both areas that each step of production is under strict control and well documented.

The HACCP-Hazard Analysis of Critical Control Point system is a risk assessment system in the production of food. The Pillsbury Company pioneered the HACCP concept in the 1960s. The United States Army and the National Aeronautics Space Association (NASA) collaborated for the production of safe foods for the United States space programs that guaranteed safety of the foods that would be consumed in space. In the early 1980s, other major food companies adopted the HACCP approach.
The HACCP system describes the hazards and the risks, which can occur during the food production. The HACCP is a system, which enables the control of the risks for each step in the production process. Risk parameters can be biological (e.g. bacterias), physical (e.g. stones in salad) or chemical (e.g. residues of cleaning fluid).

The principles in the application of HACCP can be summed up as follow:

  • Assemble a team
  • Describe the product and process
  • Identify the intended use
  • Construct a flow diagram
  • On-site confirmation of flow diagram
  • List all potential hazards and any measures necessary to control identified hazards
  • Determine the critical control points (CCP)
  • Establish critical limits for each CCP
  • Establish a monitoring system for each CCP (e.g. plans for cleaning and control plans for the temperature of foods and cooling system)
  • Establish corrective actions, verification procedures and accurate record keeping respectively.


However, keep in mind that no production process can be absolutely free of risks. Many different production steps and the human factor will increase the risk every time. Thereby the target of such a system can only be the minimization of the hazard. Minimal bacterial contamination can be a hazard to the health, because micro organisms can multiply under beneficial conditions within 15-20 minutes, which means that the number has been doubled.

A lot of recommendations and directives, defined in the risk analysis of an HACCP system for the area of food are also applicable to the pharmaceutical industry. The procedures of finding the CCPs, defining control steps and definition of influence parameters are comparable. However, there are also some differences that have to be taken into account. Medicinal products influence the bodily functions much more than foods.

Pages: 50

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