Hazard Analysis and Critical Control Point HACCP System

Abstract

HACCP is a systematic method for the identification, assessment and control of safety hazards. Such hazards are defined as biological, chemical, or physical agents or operations that are reasonably likely to cause illness or injury if not controlled. In the manufacture of  manufacture of certain antibiotics, hormones, cytotoxic substances or other highly active pharmaceuticals, together with operations such as fluid-bed drying and granulation, which are examples of hazard unit operations. HACCP plans are focused on hazards, the overall objective being to ensure that pharmaceuticals are safe for use.(1)
The use of inflammable solvents (solutions) and certain laboratory operations may constitute hazards.The following elements of the HACCP methodology are integral parts of the validation master file:
— development of a flow diagram of the process;
— verification of the flow diagram on site.

In addition, HACCP will extend this concept to include an analysis of the critical quality variables as well as the assessment of hazards affecting the safety of workers and environmental pollution hazards directly related to the concerned.(2)