EEC expands approaches to validation, qualification of GMP drug manufacture
MINSK, Jul 15 - PrimePress. The Council of the Eurasian Economic Commission (EEC) has adopted a new version of the Good Manufacturing Practice (GMP) rules, which sets out a greatly expanded approach to the validation and qualification of drug manufacturing, the EEC says.<br> <br> The possibility to replace validation by continuous verification of manufacturing process, ongoing verification of manufacturing process or verification (validation) of individual stages is introduced for the first time. Manufacturers will also be able to use a hybrid approach to process validation.<br> <br> The GMP rules will be synchronized with the current European version.<br> <br> The new version of the annex to the GMP rules allows manufacturers to confirm that the system or process of production is well studied, properly set up and operated, has a reliable system of product quality control, and ensures compliance with quality parameters.<br> <br>
2021-07-15
Primepress
EEC expands approaches to validation, qualification of GMP drug manufacture
The possibility to replace validation by continuous verification of manufacturing process, ongoing verification of manufacturing process or verification (validation) of individual stages is introduced for the first time. Manufacturers will also be able to use a hybrid approach to process validation.
The GMP rules will be synchronized with the current European version.
The new version of the annex to the GMP rules allows manufacturers to confirm that the system or process of production is well studied, properly set up and operated, has a reliable system of product quality control, and ensures compliance with quality parameters.