A global healthcare company is voluntarily recalling 1,468 product samples from the U.S. market because they were stored at temperatures below storage requirements. The products affected are used to lower blood glucose levels in people with diabetes. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 4 deals with questions related to documentation.
The latest version of the "REPORT ON THE RISK OF POTENTIAL PRESENCE OF NITROSAMINE IMPURITIES" has been available on the APIC website since April 2021. The questionnaire is to be seen as a summary report and can be used to document the results of the risk assessments with regard to contamination by nitrosamines in APIs.
The FDA adopted the ICH Q12 Guideline for post-approval change management. The guideline is intended to complement the existing ICH Q8 to Q11 Guidelines. It is composed of a Core Guideline and two Annexes with practical examples for ECs and PACMPs.
After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry" with some further clarifications.
The ICH has published a draft version of the updated principles that are currently under development by the ICH E6(R3) EWG. Amongst others, the updated version includes revised and expanded principles regarding GMP for IMPs.
The UK MHRA has established a new GMDP database with information issued by the MHRA and from EudraGMDP relating to manufacturing, wholesale authorisations and certificates and non-compliance statements.
An inspection by the Dutch authority in February revealed a number of deficiencies at a manufacturer of advanced therapy medicinal products (ATMPs). The Non Compliance Report that was published shows which of these were critical.