During this period where MHRA has been conducting predominantly remote inspections, we have reflected on some of the common factors in critical deficiencies we have been seeing in control strategies for cross contamination between products in shared facilities.
Leading Senior GMP Inspector
Q&As clarifying expectations for implementation of the HBEL guide and cross-contamination control requirements were published in April 2018
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This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.
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- A fresh look at an old topic: Investigations in the GMDP environment
- Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance.
- GCP Serious Breaches update
- MHRA planning for return to on-site Good Practice (GxP) inspections
- A Practical example of applying Quality Risk Management in GDP – Transportation Risks