There were multiple partied involved in this process and MIAS Pharma played an important role:
- MIAS Pharma – Project Management and EU QP Batch Release
- A contractor for UK QP Batch Release
- A Product Owner and Clinical Trial Sponsor
- A Drug Substance Manufacturer
- A Test Lab for Drug Substance
- A Storage and Distribution Service Provider
- UK regulatory body MHRA
What happend?
- The Investigational Medicinal Product Dossier (IMPD) version 1 for clients product listed an incorrect address for one of the test labs.
- The contractor of UK QP Batch Release, certified and released a batch of owner’s product using IMPDv1.
Why is this important?
- The IMPD is the document that is filed with the regulators as the standard for how a batch will be manufactured and tested.
- The person doing batch certification and release must verify that the batch is produced and tested at the sites listed in the IMPD. This ensures that product quality and patient safety are maintained.
The test site listed in the IMPD was a specific address, while the test was actually done at a site in a different address. The Investigation and Cleanup
What was wrong this time?
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1.
Stage 1
MIAS informed the product owner and the contractor of UK QP Batch Release of the error.
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2.
Stage 2
The contractor of UK QP Batch Release contacted the Storage and Distribution Service Provider to check if the product had been shipped to patients. Fortunately, it had not been shipped and was placed in quarantine so the address mixup could be investigated.
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3.
Stage 3
The contractor for UK QP Batch Release investigation found that a small error in 1 address in the supply chain information from the Drug Substance Manufacturer had been missed through several reviews and made it into IMPD v1.
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4.
Stage 4
The contractor for UK QP Batch Release informed the MHRA of the error. Because the product was not tested at the site listed in IMPD v1, a product recall could have been required, however both the contractor for UK QP Batch Release and product owner felt that there was no threat to patient safety or product quality as the product had been tested using the correct method and complied with specification.
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5.
Stage 5
The final decision was that this was an administrative error that would be resolved at the next update of the IMPD, and this was accepted by MHRA.
Key takeaways
Verifying that information is correct is crucial to compliance.
It only takes one relatively small error missed at the start of a process to grow into a much bigger problem.
The outcome and positives
No patients were harmed as a result of the error!
MIAS Pharma, and all parties involved acted quickly to report the issue and were open and transparent with the regulators.
The mistake was investigated thoroughly and corrected without delay.
IMPD is now on v3 and contains correct addresses for all sites involved in the manufacture and testing of the product.
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