GMP News - Quality Assurance

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 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.

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

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.

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).

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.

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?