EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (IP Value 2.40) , Web of Science Group (Under Process) , Directory of Research Journals Indexing , Scholar Article Journal Index (SAJI) , International Scientific Indexing ( ISI ) , Scope Database , Academia ,

ISSN 2394-3211

Impact Factor: 7.065

ICV - 79.57

Abstract

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.

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