REGULATORY GUIDELINES OF HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) IN USA, AUSTRALIA AND INDIA IN RELEVANCE TO PHARMA INDUSTRY

Parul J. Juneja*, Dr. Ronak Dedania and Dr. Vineet Jain

ABSTRACT

HACCP is a systematic method for the identification, assessment and control of safety hazards which are common in the manufacturing process of APIs. Being a new and innovative concept in the pharmaceutical industry, training of personnel in industry, government and universities in HACCP principles and applications is essential for its effective implementation. This paper details the seven principles for HACCP that have been mentioned in Codex Alimentarius Commission (CAC) guidelines. This paper also addresses the Certification procedures that shall be carried out as per ISO/IEC 17021 and ISO/TS 22003 requirements in India, Australia and USA. There are different Standards to comply with HACCP in India, Australia and USA. Regulatory requirements for HACCP in these 3 countries have also been included in this paper.

Keywords: HACCP, Pharma industry, Regulatory requirements, Standards, Certification procedures.