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Good distribution practice

Annex 16 QP certification and batch release – frequently asked questions – part 1

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In this post you’ll find the first in a series of ‘frequently asked questions’ related to the updated EU GMP Annex 16 on QP Certification and Batch Release.

Overview of compliance management escalation processes used by the GMP Inspectorate

Iceberg on the horizon

At the GMDP Symposium 2016, Andrew Hopkins and I gave a presentation about the Inspection Action Group (IAG) and Compliance Management Team (CMT), to highlight the systems and processes in place for when compliance issues are identified at manufacturing and …

Around the world in 80 ways (part 1 of 2)

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Hot air balloon

The supply chain for Active Pharmaceutical Ingredients (APIs) has been increasing in complexity for a number of years with the potential for a number of players to be involved, with multiple possible routes around the world available (significantly more than …

Who inspects the Inspectors? (Part II)

Diagram demonstrating that factors such as policy. standards, control, regulations and laws are all building blocks for compliance

In the October blog post we told you about the successful audit of the GMP Inspectorate under the JAP programme.  Later that month the entire Inspectorate was assessed as part of the BEMA programme.

Joining and working for the Inspectorate

Reaching for the sky

When I applied to join the Inspectorate I was working as a Qualified Person. I’d been on the receiving end of many inspections and thought that the role looked to be a hugely interesting one with a great amount of …