Application of HACCP to IVD Manufacturers

In December, 1995, the Food and Drug Administration (FDA) issued seafood regulations based on the principles of Hazard Analysis and Critical Control Points (HACCP). The FDA issued these regulations to ensure safe processing and importing of fish and fish products. FDA will soon be requiring the rest of the food industry to implement HACCP programs, and more recently FDA has initiated pilot HACCP programs within the medical device industry.

The intent of the HACCP program is to assist manufacturers in defining very clearly the critical control points (CCP) during product manufacturing and distribution. Once defined, the CCPs are to be assigned operating limits and monitored in order to prevent product failures. FDA has made it clear that HACCP is not a replacement of GMPs, but can be used as a management tool to protect the product supply against biological, chemical, and physical hazards. The program is intended to be preventive, not reactive.

Ideally, if a HACCP plan works as intended, FDA claims that it will prevent product failures and recalls. Also, FDA believes that their GMP inspection time at a firm can be dramatically reduced from a 10-14 day period to a 2-3 day period.

The HACCP program requires a company to develop a plan based on a narrative and flow chart of its processes from raw material acceptance to final product distribution. This exercise is best accomplished by review and input from various key individuals throughout the company. Once this has been established, the HACCP plan can move forward by carefully reviewing each step of the process and identifying the critical control points in the process that can prevent hazards (biological, chemical, and physical) that could cause illness or injury to the public or patient.

There are 7 principles of a HACCP plan: