Importance of Self - Inspection in Pharmaceutical Industry as Per Various Regulatory Guidelines
Chagi Venkatesh and S. B. Puranik

Prist University, Thanjavur, Tamilnadu, India.

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Abstract: The purpose of this study is to compare the various regulatory guidelines and consign the self inspection requirements on a single platform and evaluate the requirements to make a common prerequisite. The Importance of self-inspection in pharmaceutical industry is to identify the non-compliance with respect to Manufacturing Practices of production, Quality Control systems, quality assurance procedures, engineering practices, environmental conditions etc., the self-inspection programme is intended to detect and analyze the observations and suggest the necessary corrective actions. Such inspections should be planned with technical persons, having knowledge with respect to the regulatory requirements in that particular field. The inspection shall be conducted for all the departments in the manufacturing facility as per regulatory requirements at least once in year, based on the organization requirements it can be carried out once in quarter or biannually to make sure that all the systems and procedures are under control. Self inspection can be initiated  in case of emergencies where the product needs to be withdrawn from the market or recurrence of product failure in the facility or frequent breakdown of the machines or repetitive nature of the packaging components  or in case of pre notified regulatory/Customer inspection to the facility etc., The identified observations during audit needs to be discussed during the closure meeting  and same shall be updated and  linked through CAPA system and follow-up till the  closure of these observations.

Keywords: WHO; Schedule M; USFDA; TGA; MHRA; PICS Regulatory Requirements

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