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Search results with tag "Manufacture of the finished"

active substance, excipient and primary container ...

www.ema.europa.eu

All filters used in the manufacture of the finished product that come in contact with the finished product, or with any component (substance or intermediate product) incorporated in the finished product should be described and the information stated in Table3, section 4.1.5 should be provided in the quality dossier.

  Active, Primary, Finished, Excipients, Container, Manufacture, Substance, Active substances, Excipient and primary container, Manufacture of the finished

Guideline on stability testing for applications for ...

www.ema.europa.eu

6.11. (B.II.b.3.b) Change in the manufacturing process of the finished product, including an intermediate used in the manufacture of the finished product: Substantial changes to a manufacturing process that may have a significant impact on the quality, safety and efficacy

  Finished, Manufacture, Of the finished, Manufacture of the finished

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