GMP NEWS 2018

Drug manufacturer IDT Australia Ltd. received an FDA warning letter in May 2018. It was criticised during the FDA inspection that OOS results of assay determinations had not been investigated and that a batch had been released even though three consecutive identity tests had failed. Read more about the IDT Australia FDA warning letter here.

New suggestions by the USP on chapter <659> have been published in the Pharmacopeial Forum (PF) 44 (4). It addresses plastic packaging as well as the regulations and requirements for child-resistant packaging. Read more about chapter <659> - Packaging and Storage Requirements in this article.

ICH Q12, currently in draft form for public consultation, provides an opportunity to save time and money associated with regulatory submissions. Read more about "new" lifecycle tools and enablers for global post-approval change management provided in the proposed guideline on "Life Cycle Management".

Quite a few supervising authorities in the health care sector come for GMP inspections also to foreign countries. Read what the Brazilian ANVISA and the Mexican COFEPRIS will expect.

The FDA published two new draft guidelines on Risk Evaluation and Mitigation Strategy (REMS) for sponsors of clinical trials. Read more about the draft documents on developing a shared system REMS, and waivers associated with the single, shared system REMS requirement.

EU inspectorates already accept inspections of the FDA at US sites. But there will still be auditors coming from the EU to the US.

Ireland’s Health Products Regulatory Authority (HPRA) recently shared an advice for Academic Sponsors and has updated its guide to clinical trial applications.

The revised Annex 17 of the EU GMP Guide has been publised and will come into operation on 26 December 2018. Read more about the guideline on Real Time Release Testing and Parametric Release.

Chinese manufacturer of active pharmaceutical ingredients Jilin Shulan Synthetic Pharmaceutical received an FDA warning letter in May 2018. It was criticised in particular that the Company did not record, investigate and solve laboratory OOS results. It was also criticised that the Audit Trails of the electronic laboratory instruments (HPLC, GC, IR) were not enabled. Find out more about the Jilin Shulan Synthetic Pharmaceutical Warning Letter.