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Quality management
Quality Management
1 Principles
Among GMP other aspects, such as environmental controls, and safety, are necessary to be taken into account in order to be in compliance with regulations. Business ...
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About the project
About the project
This site was created for:
- combining the efforts of specialists in the pharmaceutical industry of various countries to achieve high quality drugs;
In the news section you can...
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General requirements for personnel
General requirements for personnel
Staff must understand how they can influence quality, GMP compliance and contribute to improvement. Staff at all levels must be competent and be effectively managed....
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Active Pharmaceutical Ingredients
Active Pharmaceutical Ingredients
Historical Background
When the initiative was taken by PIC/S at the Canberra meeting in September 1996 to draft a globally harmonised Good Manufacturing Practices ...
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Outsourced Activities
Outsourced Activities
Principle
Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid misunderstandings which could res...
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Documentation
Documentation
Proper documentation is an integral part of the quality assurance system and is a key element of the work in accordance with these Rules. In the manufacturer's quality management system,...