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

1. BS EN ISO 9004:2009. Managing for the Sustained Success of an Organization. A Quality Management
Approach
2. Pharmaceutical Inspection Co-operation Scheme - Leading the international development, implementation
and maintenance of harmonized GMP standards and quality systems of Inspectorates in the field of
medicinal products.
3. Sultanate of Oman – Ministry of Health, Guidance.
4. International Council for Harmonisation (ICH) Guidance: Quality Guidance Documents.
5. GCC Guideline - Gulf Co-operation Council (GCC) States
6. Saudi Food & Drug Authority - Guide to Good Manufacturing Practice for Medicinal Products -
The basic concepts of Quality Assurance, Good Manufacturing Practice, Quality Control and Quality
Risk Management are inter-related. They are described here in order to emphasize their relationships and
their fundamental importance to the production and control of medicinal products.
7. L. X. Yu, A. Raw, R. Lionberger, R. Rajagopalan, L. Lee, F. Holcombe, R. Patel, F. Fang, V. Sayeed, P. Schwartz,
R. Adams, and G. Buehler. U.S. FDA question-based review for generic drugs: A new pharmaceutical quality
assessment system. J. Generic Med 4:239–248 (2007).
8. Title 21--Food and Drugs Chapter I--Food and Drug Administration Department of Health and Human
services subchapter c--drugs: General - Part 211 current Good Manufacturing Practice for Finished Pharmaceuticals
9. EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines - Volume 4 of “The rules governing
medicinal products in the European Union” contains guidance for the interpretation of the principles
and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.
10. World Health Organization (WHO) good manufacturing practices for pharmaceutical products: “Good practices in production and quality control”, provides guidance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of QA.
3. These two parts were subsequently supplemented by further guidelines which are integral parts of these
GMP for pharmaceutical products. All these texts are available on the Medicines web page
4. (http.www.who.int/medicines/organization/qsm/ activities/qualityassurance/gmp/gmpcover.html).
11. Medicines & Healthcare products Regulatory Agency regulates medicines, medical devices and blood
components for transfusion in the UK. Recognized globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.

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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 http://www.medicaljournalshouse.com/index.php/JDrug-Discovery-Development/article/view/53

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Vol. 1 No. 1 (2017): Journal of Drug Discovery and Development

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