FDA Warning Letters in Fiscal Year 2021: Deficient Stability Tests Reason for most frequent Complaints
During an FDA inspection, the area of quality control is always closely investigated. This is reflected in the citations in the Warning Letters of the past fiscal year. Find out where the most frequent GMP violations occurred and what the FDA inspectors had to complain about with regard to stability tests on active ingredients and finished medicinal products.
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.
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?
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.
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.
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.
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.
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).
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.
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.