It's a frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP-compliant equipment design.
MHRA´s GCP inspectors have recently seen various types of Electronic Health Records (eHRs) during their investigator site inspections and in several cases they have given major findings.
The European Commission published version 15 of the Q&A´s on Safety features for medicinal products for human use. The new version includes a revision of the Q&A on safety features relating to IMPs.
With an additional program to support manufacturers of cells, tissues and cell-based products, the FDA is trying to accelerate its promotion of the development of regenerative therapies.
The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 5: Are regulations necessary for the handling and management of data generated by small systems (e.g. pH meters, filter integrity testers, etc.)?
The WHO has reacted to the changes in the European Pharmacopoeia by issuing a draft guideline on the production of WFI (Water for Injection). The commentary phase is open to the public, comments can be submitted until 20 September 2019.
The EMA points out that - independent from the Brexit postponement - MAHs should use the remaining time to complete all necessary preparations.
The US FDA issued a Warning Letter to a US company with aseptic production due to serious deficiencies in room zoning, personnel, environment monitoring and disinfection.
The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs). What does the draft contain?
In a previous news it was pointed out that one EU Member State (Slovakia) was still missing for the complete implementation of the MRA agreement between the EU and the USA. The goal was for all EU Member States to be recognised by 15 July 2019. Now, this goal has been achieved.