Dubininskaya str. 57, bld.1, 115054, Moscow, Russia
info@regapharm.com

+7(499)517-95-23

Main  >  News  >  EEC adopted a new edition of the annex to GMP rules

EEC adopted a new edition of the annex to GMP rules

The Council of the Eurasian Economic Commission adopted a new edition of Appendix No. 15 to the rules of good manufacturing practice (GMP), the press service of the EEC reports.

The new revision of the application allows the manufacturer to confirm that the system or production process is well understood, properly configured and operated, has a reliable product quality control system and ensures that products are produced with specified quality parameters.

“The application establishes new, significantly expanded approaches to validation and qualification of manufacturing processes. For the first time, indications are introduced on the possibility of replacing validation with continuous verification of the production process, ongoing verification of the production process or verification (validation) of individual stages. Manufacturers will also be able to use a hybrid approach to validate the production process, ”the statement says.

As a result of the changes, the GMP rules will be synchronized with the current European edition, the EEC notes.

In June, the EEC Board approved the recommendations “On guidelines for the transfer of technologies and (or) analytical methods in the production of medicines”. The document provides instructions for pharmaceutical manufacturers, accredited testing laboratories, pharmaceutical inspectorates and expert organizations on the actions necessary for a successful transfer of technologies and analytical methods between structural units within one or more production sites, as well as between accredited testing laboratories.

Make request

Your name

Your phone

Your email (required)

Choose the topic of your message

Your message