What to expect from GPvP inspections
...Our objectives on inspection revolve around getting a clear picture of the processes and data that make up your pharmacovigilance system. A successful inspection for us is one where we...
Search results for data integrity
Maintaining control: Remote working and QP certification
...QC test results, transportation records, etc), together with any relevant deviations, OOS reports or change records. In addition, they also rely on supporting information such as product trend data, the...
Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance.
Posted by:
Graeme McKilligan, Posted on:
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Categories:
Compliance matters, Good manufacturing practice
...(or critically assess existing controls) is a key use of the Health Based Exposure Limit studies. Risk Management requires a focus and a perspective as well as knowledge and data....
Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward
Posted by:
Gail Francis, Martin O'Kane, Kirsty Wydenbach and Lisa Campbell, Posted on:
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Categories:
Good clinical practice, Inside the Inspectorate
...part, we explore the challenges ahead. Remote access to EHRs is something we have addressed during the pandemic, to facilitate source data verification (SDV) and monitoring. We have attached restrictions...
Decentralised Manufacturing: emerging considerations
Posted by:
Elspeth Gray, Ian Rees and Martine Powell, Posted on:
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Categories:
Clinical Trials, Decentralised Manufacturing, Good manufacturing practice, Innovation, Med Regulations, Point of Care
...eligibility. In all instances, data or published literature should be presented to support claims around clinical benefit. The role of the MHRA in assessing product quality, safety and efficacy is...
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