GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS

PRINCIPLE

The Good Manufacturing Practices for pharmaceutical products is aimed to ensure that products are consistently manufactured to meet specified quality appropriate to their intended use. It is concerned with all aspects of production and quality control.

GENERAL

In the manufacture of pharmaceutical products, overall control is essential to ensure that consumers receive products of high quality. Haphazard operations cannot be tolerated in the manufacture of products intended to save life or to restore or to preserve health.

It is not sufficient that the finished product passes testing protocols, but quality must be built into the product. The quality of pharmaceutical products depends on the quality of starting materials and packaging materials, production and quality control processes, building, equipment and personnel involved.

Sole reliance should not be placed on any test for assurance of quality. All products should be manufactured under carefully controlled and monitored conditions.

The good practices given hereunder should be considered as guidelines with the objective of ensuring that the products are of the nature and quality intended; wherever necessary, they may be adapted to meet individual needs, provided that established standards of product quality are still achieved.

Administrative measures of Drug Regulatory Authority (DRA) should be directed towards the application of these standards in practice, and any new or amended national regulations for good manufacturing practice should at least meet their level.

These standards are also intended to serve manufacturers as basis for elaboration of specific rules adapted to their individual needs.

In addition to general matters of Good Manufacturing Practices outlined in the chapters of this Guide, supplementary guidelines have been incorporated. The purpose of the supplementary guidelines on other subjects is to provide details about specific areas of activity which may not necessary apply to all manufacturers.

Herein apply to medicines and similar the standards set out products intended for human use.

It is recognized that there are acceptable methods, other than those describes in this Guide, which are capable of achieving the principle of the Guide. This Guide is not intended to place any restraint upon the development of new concepts or new technologies, which have been validated and provide a level of Quality Assurance at least equivalent to those set out in this Guide.

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