Quality Management System in the Pharmaceutical Industry: A Review

Authors

  • Mr. Anupam Gulabdhar Pandey

Keywords:

Quality Manuals, Directives, SOP, Guideline, Regulatory

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.

References

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3. These two parts were subsequently supplemented by further guidelines which are integral parts of these
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Published

2018-10-26

How to Cite

Pandey, M. A. G. (2018). Quality Management System in the Pharmaceutical Industry: A Review. Journal of Drug Discovery and Development ( ISSN:2581-6861), 1(1), 40-47. Retrieved from https://medicaljournalshouse.com/index.php/JDrug-Discovery-Development/article/view/53