GMP NEWS 2018

Revision of USP chapter on NIR

Besides IR and Raman, NIR is frequently used in the inspection of incoming active ingredients and excipients. New suggestions for updating the two NIR chapters were issued in the USP's Pharmacopeial Forum. Please find more information on the changes to the USP chapters <856> and <1119> on near-infrared spectroscopy.

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PSURs: EMA revises Post-Authorization Procedural Advice

The EMA recently revised its post-authorization procedural advice for users of the centralized procedure. Read more about new and revised Q&A´s concerning Periodic Safety Update Reports (PSURs).  

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Bizarre Warning Letter to Chinese Drug Manufacturer

Over the past months, the ECA reported about the growing number of Warning Letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products.

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New Annex 1: Consequences for the QP

The new  draft of Annex 1 (Manufacture of Sterile Medicinal Products) will be much more extensive and contain some new rules and additions. There are also some things in the Annex 1 draft QPs need to consider.

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EMA revises Post-Authorization procedural Advice

The European Medicines Agency (EMA) recently revised its post-authorization procedural advice for users of the centralized procedure.

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What Will Change with the New GMP Directive?

The GMP directive is dead - long live the GMP directive. It was with this phrase that new kings were announced in France in order to demonstrate the monarchy's continuity. But what about content consistency between the old and the new directive? What are the differences between both GMP directives? What will change in the new GMP directive, what will stay the same?

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Ph. Eur. Monograph on Rubber Closures revised

The revised Ph. Eur. Monograph 3.2.9. on rubber closures will become official on July 1, 2018 (Supplement 9.5). Read more about Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders.

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Switzerland: important Amendments to the MRA

Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.

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Effects of the Annex 1 draft on 100% inspection of Parenterals

After many postponements, the long awaited Annex 1 draft of the EU GMP Guideline has finally been published on 20 December, 2017. While the chapters on integrity testing and visual inspection of injectables used to be rather short, the draft now contains several updates.

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Missing Tests for Identity lead to FDA Warning Letter

A Canadian manufacturer of medicinal products received an FDA Warning Letter due to the fact that not all batches of manufactured drug products and the active materials used therein had been tested for compliance with the specifications before their release. Get information on the Cellex-C FDA Warning Letter.

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European GMP Inspector discovers Cleaning and Process Validation Deficiencies

It's a well-known fact that the US FDA publishes GMP deficiencies in their Warning Letters. For some years now, there has also been a European portal, where non-compliance results are published. In August 2017, an Upper Bavarian supervisory agency has issued such a statement of non-compliance with GMP to an Indian manufacturer of medicinal products. Which deficiencies were found?

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GMP Update - what's new in the EU?

The GMP world was turning a bit slower in 2016 - now, it's picking up speed again. Currently, several crucial changes are being made with consequences even for national legislation.

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