Quality Management System in the Pharmaceutical Industry: A Review

Anupam Gulabdhar Pandey

Abstract


Quality Manuals provide the overall information about the working of the department. Issues concerning regulatory requirements and quality are further interpreted by means of Directives or Guidelines. Directives are reserved for those cases where regulations do not allow any freedom with regard to their implementation. Finally SOPs define the actual systems in place on the shop floor. The Policy is a high level overall plan embracing the general goals and acceptable procedures. The purpose is the establishment of general conditions regarding the product quality and conformity with official standards. The Directive is a document that serves to direct, guide, and usually impel toward an action or goal; especially an authoritative instrument issued by a high-level body or official. It supplies instructions concerning the quality system of the Unit. It leaves only a small margin due to legal constraints. In Pharmaceutical Industry the Guideline is an indication or outline of policy or conduct. It has the same scope as the Directive. Describes general procedures of a defined activity or operation, leaves more freedom of action than the Directive. The SOP is an authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material, but of a more general nature (equipment operation; maintenance and cleaning; cleaning of premises and environmental control; sampling and inspection). SOPs must be developed to define the work of operators and addressed to standardize the approach during operations.


Keywords


Quality Manuals, Directives, SOP, Guideline, Regulatory

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References


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