Variations: How to submit Results of Confirmatory Stability Studies

New Drug Approvals

Variations: How to submit Results of Confirmatory Stability Studies

The Co-ordination Group for Mutual Recognition and Decentralised Procedures has revised the Q/A-List for the Submission of Variations adding a question and answer regarding the submission of the results of confirmatory stability studies on production-scale batches. Read more.

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http://www.gmp-compliance.org/enews_4313_Variations%3A%20How%20to%20submit%20Results%20of%20Confirmatory%20Stability%20Studies_8358,Z-RAM_n.html

Variations: How to submit Results of Confirmatory Stability Studies

As a part of the Heads of Medicines Agencies, the CMD(h) (Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human) is publishing a number of interesting documents. Best Practice Guides questions-and-answer documents give valuable information regarding the point of view of the European registration and supervisory authorities. Now, the Q/A-List for the Submission of Variations has been updated. Question 2.13 is dealing with the submission of the results of confirmatory stability studies on production-scale batches where stability data for pilot-scale batches have already been accepted during application for a…

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