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Sunday, December 12, 2021 5:34:41 PM
"The certificate is issued based on a remote inspection of GMP compliance during COVID-19 travel restrictions. A risk-based site inspection programme remains in force."
We know from the press release issued on the subject of HTA certification, that the physical site inspection was already conducted:
"The original inspection timing was delayed by MHRA due to their caseload; however, the week-long onsite review by two MHRA inspectors was recently completed. The final phase of the process involves receiving an official MHRA inspection report and taking any responsive actions that may be required. The Company currently anticipates that this process will be completed before year-end."
Based on the likelihood of gaps being procedural & documentation based, I believe they will still meet the anticipated timeline.
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