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There is a strong urgency to synchronize the laboratory practices so that a common standard of quality can be achieved. Two guidelines namely, the ISO 17025 and WHO Good practices for pharmaceutical quality control laboratories are especially helpful and being practiced in the pharmaceutical quality control laboratories around the world. The ISO/IEC 17025: 2005 released in May of 2005 as a second and the latest edition provides specific guidance on the application of the ISO 9001 principles to laboratories. These guidelines are consistent with the requirements of the WHO guidelines for good manufacturing practices, and with the requirements of the International Standard ISO/IEC 17025:2005, and provide detailed guidance for laboratories performing quality control of medicines. Compliance with this standard provides a globally accepted basis for laboratory accreditation. WHO Good practices for pharmaceutical quality control laboratories provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products should be performed to demonstrate that reliable results are obtained. Both of these standards aim in acquiring international harmonization in Laboratory practices and services
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There is a strong urgency to synchronize the laboratory practices so that a common standard of quality can be achieved. Two guidelines namely, the ISO 17025 and WHO Good practices for pharmaceutical quality control laboratories are especially helpful and being practiced in the pharmaceutical quality control laboratories around the world. The ISO/IEC 17025: 2005 released in May of 2005 as a second and the latest edition provides specific guidance on the application of the ISO 9001 principles to laboratories. These guidelines are consistent with the requirements of the WHO guidelines for good manufacturing practices, and with the requirements of the International Standard ISO/IEC 17025:2005, and provide detailed guidance for laboratories performing quality control of medicines. Compliance with this standard provides a globally accepted basis for laboratory accreditation. WHO Good practices for pharmaceutical quality control laboratories provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products should be performed to demonstrate that reliable results are obtained. Both of these standards aim in acquiring international harmonization in Laboratory practices and services
To view the article please copy and paste the following link on the web browser:
https://drive.google.com/file/d/0B-ge_xm5MFzXR056OWxra3NGRW8/view?usp=sharing
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