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Good laboratory practice

EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase

Handshake in front of Usa and Eu flags

Today marks the start of the operational phase of the EU-FDA mutual recognition agreement

PIC/S - Press release and news of TFDA hosted meetings and seminar, September 2017

PIC/S walking stick

From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)

Too much pressure: a behavioural approach to Data Integrity (Part 2)

Chemist wearing safety glasses and using a tablet

The first post in this series described the importance of organisational behaviour on the success of data integrity control measures.  Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.

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.

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.