GMP NEWS 2017

The recently published ICH question/answer document on starting materials specifies the regulations of the guideline ICH Q11. Read more about what is important in terms of the selection of starting materials and their justification and what data needs to be supplied in the marketing authorisation dossier.

Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Here is what you need to know about becoming a Qualified Person.

The EMA published its new Guideline on Manufacture of the finished dosage form. The new EU guidance will help applicants in preparing marketing authorization dossiers and in what to include in Module 3 of their common technical document.

There is a new commitment between EC, EMA and FDA allowing to share full inspection reports between agencies.

Recently, the FDA published a new Guidance for Industry draft document. It is intended to help medical gas manufacturers introduce and implement GMP regulations. Read more about GMP requirements for medical gases.

The ECA Validation Group was established with the goal to gather knowledge on validation, for example by continuously developing a Process Validation Good Practice Guide. Find out more about what is new in the ECA Validation Group.

After the change to the European Pharmacopoeia, it is possible to produce water for injection by other methods than distillation since April 1st 2017. The European Medicines Agency (EMA) published a Q&A draft document in 2016 as an additional guideline. These Questions & Answers on WFI have now been published in its final version.

The European Medicines Agency (EMA) recently published a collaborative clinical trials approach together with the FDA for rare paediatric diseases. Read more about the joint proposal "Paediatric Gaucher disease - A strategic collaborative approch from EMA and FDA".

In the manufacturing and release of IMPs, not all requirements of Annex 16 can be transferred one to one. MHRA is now trying to clarify the most important questions.