EMA Details Requirements for Finished Dosage Forms Manufacture

The European Medicines Agency has issued draft guidance on the manufacture of finished dosage forms, clarifying what information drugmakers should include in the quality section of the common technical document that is part of a premarket application.

For each stage of the manufacturing process — including assembly and testing — applicants should provide details on all sites involved. The descriptions should be comprehensive and include batch sizes, equipment type used and when release testing is performed. Any technical adaptations a drugmaker employs — such as using different pieces of equipment for the same manufacturing step at different sites — need to be specified as well, the EMA says.

Drugmakers should specify the batch formula for the intended batch size, and in cases where a range of batch sizes are proposed, the formula for the highest and lowest should be provided, the agency adds.

The EMA also wants drugmakers to identify the points in the manufacturing process where controls, intermediate tests or final product controls are conducted. In complex cases — such as applications for biotech products or the use of continuous manufacturing processes — the CTD should explain how the applicant manages accidental deviations from the approved process to ensure the product’s quality is maintained.

Comments on the guideline are due Jan. 9, 2016. Read it at www.fdanews.com/07-10-15-EMADraft.pdf. — Kellen Owings