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Too much pressure: a behavioural approach to Data Integrity (Part 1)

Burst water pipe, leaking water

Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners.

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

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice

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)

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
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 …