GMP News

In October and November, the European Medicines Agency (EMA) once more published on its website the updated and revised version of the "Questions & Answers (Q&A)" document related to questions prior to and during the submission of a centralised procedure.

As international travel restrictions remain in place, the TGA's GMP remote inspection programme will continue. This means remote inspections remain the only available option for certification applications during the pandemic.

With Dr Robert Califf, President Biden has now nominated an expert in clinical trials who has previously served as an FDA Commissioner.

The Commission Implementing Regulation (EU) 2021/1280 lays down the good distribution practices for active substances used as starting materials in veterinary medicinal products. It applies to importers, distributors, and manufacturers. The Regulation has been binding since August 2021 and is directly applicable in all Member States. We have summarised the most important requirements of the new Regulation.

Do you know that many supporting documents are available free of charge in the member's area of the European GDP Association? To get an idea, take a look here.

In the current Pharmacopeial Forum, PF 47(6), a stimuli article entitled The Case for Apex Vessels was published.

An interesting case of two fires occurred at an API manufacturer in the USA. This is described in a Warning Letter from the FDA that was recently published.

Recently the FDA issued a Warning Letter due to lack of control over computer systems and violation of data integrity. During the inspection the use of multi user access to raw data files and falsification of records were observed.

A few but fundamental GMP requirements for pharmaceutical quality control laboratories are a frequent focus of regulatory inspections. During a visit to a U.S. contract laboratory, FDA inspectors found serious deficiencies in these requirements, resulting in a Warning Letter due to inadequate handling of OOS results, lack of electronic system security and data manipulation.

The FDA issued a warning letter for not complying with regulations during the clinical investigation of a COVID-19- IMP. In particular, the sponsor failed to submit an investigational new drug application.

Due to the Covid-19 pandemic personal presence of pharmaceutical customers at the supplier site has generally been reduced or even become impossible - especially for FAT. So “remote-FATs” came up more and more in the last year and are still used. But how successful are such remote FATs? What are the problems showing up? This was something we wanted to find out from you, to get an overview - and therefore a survey was set up. Find out what the survey results were.

The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.