Quality Management System in the Pharmaceutical Industry: A Review

Anupam Gulabdhar Pandey


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.


Quality Manuals, Directives, SOP, Guideline, Regulatory

Full Text:



BS EN ISO 9004:2009. Managing for the Sustained

Success of an Organization. A Quality Management


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

Sultanate of Oman – Ministry of Health, Guidance.

International Council for Harmonisation (ICH) Guidance:

Quality Guidance Documents.

GCC Guideline - Gulf Co-operation Council (GCC) States

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.

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).

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


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


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.

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



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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