GMP News - Quality Assurance

30.03.22

USP collects Data for global Medicine Supply Map

The U.S. Pharmacopeia (USP) operates a so-called global Medicine Supply Map as an early warning system to counteract risks of drug shortages.

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30.03.22

France Legalizes Medical Cannabis Cultivation

France is moving forward regarding medical cannabis cultivation and production. As of March 1, it is legal to cultivate cannabis for medical purposes in France.

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23.03.22

ECA comments on FDA Guideline on Visual Inspection

In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.

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23.03.22

Version 19 of the Q&As on Safety Features

The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Do the UIs of reference and retention samples taken from stock have to be decommissioned?

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16.03.22

Revision of the PIC/S GMP Guide

The PIC/S (Pharmaceutical Inspection Co-operation Scheme) already published a new version of its GMP Guide PE016 in February. This is due to the revision of the EU regulation on clinical trials. There is also a new annex on certification by a Qualified Person and batch release.

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09.03.22

Herbal Drugs: Concept Paper on GACP Revision Published

EMA´s HMPC published the concept paper on the revision of the guideline on good agricultural and collection practice for starting materials of herbal origin. Amongst others, the revision will address the need for clarification regarding GMP vs GACP.

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09.03.22

Swissmedic specifies Requirements for GMP Certificates

The Swissmedic specified its requirements for the validity of GMP certificates in the pandemic.

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02.03.22

New WHO Guidance on Data Integrity

Last year, the WHO replaced the previous Guidance on good data and record management practices with a new Guideline on data integrity. What has changed?

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02.03.22

Turning Nasal Drops into Eye Drops - not a good Idea from the FDA's Point of View

In a Warning Letter, the FDA criticises eye drops from a Chinese manufacturer for not being manufactured under sterile conditions. The manufacturer argues that it made the eye drops under non-sterile conditions as nasal drops. Of course, the FDA did not accept this argumentation. Citing the FDA Aseptic Guide, the Warning Letter shows what the FDA considers to be the state of the art in aseptic manufacturing.

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02.03.22

Plastic Components Used in Manufacturing: USP extends Official Date for <665>

To address inquires and to give USP more time to engage with stakeholders regarding the suitability of making <665> an applicable general chapter, the USP intends to extend the official date for <665> to May 1, 2026.

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02.03.22

FDA Warning Letter: Key Aspects of the ICH Q7 Guideline disregarded

In February 2022, the U.S. FDA issued a Warning Letter (WL) to an Indian drug manufacturing site called "Indiana Chem-Port" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

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23.02.22

How do you control multiple nitrosamine contaminants in a product?

Nitrosamines can originate from a wide variety of sources and therefore can sometimes be detected as multiple impurities in finished drug products. Learn here about the control options available to marketing authorization holders in the event of multiple nitrosamine impurities in a product.

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23.02.22

Final Annex 21 published

The final version of Annex 21 to the EU GMP Guidelines ("Importation of medicinal products") was published in EudraLex Vol. 4. There were a few important additions and clarifications to the draft.

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23.02.22

How to keep up to date with GMP

How can you stay up to date with the ongoing changes in the GMP world? This question is frequently addressed during ECA courses and conferences. ECA´s weekly GMP Newsletter informs you about all relevant updates in the GxP arena.

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23.02.22

Draft revision of ICH Q9 Quality Risk Management Guideline published

Since 2005 at the latest, the topic of quality risk management has dominated almost the entire GMP sector. At that time, the corresponding ICH Q9 guideline was published as "Step 4". Now the draft of a planned revision has been published. What could be in store?

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