GMP News - Quality Assurance

It seems that there are some misinterpretations with Chapter 1.10 of the EU-GMP Guidelines, according to a blog entry of the British MHRA.

The Co-ordination group for Mutual Recognition and Decentralised Procedures - human (CMDh) of the Heads of Medicines Agencies has revised its Question and Answers Document on the QP Declaration.

The IMP Working Group within the European QP Association sent in their comments to the EU Commission on the Commission Delegated Regulation on GMP for IMPs, incuding some recommendations.

To remain 'regulatory compliant' and to ensure the continuity of product supply, systems and processes must be evaluated and the respective processes simplified and controlled. Important tools in this context are accurate Quality Metrics and Performance Indicators.

FDA's CDER has published a Guidance Agenda with planned new and revised Draft Guidances for 2017. Some of the planned FDA Guidances could be interesting for the GMP area.

There are many new developments and change notifications in the GMP area keeping the pharmaceutical industry busy, not least because many of the new requirements must be implemented soon. Read moe in our GMP Update Part 2.

The FDA published two draft gidelines on their current thinking on Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies as well as by outsourcing facilities.