The MHRA has presented their 2016 inspectorate deficiency trend data for 2016. MHRA publishes the assessment with the hope that industry will perform their own assessment against the deficiency findings, as part of self-inspection and continuous improvement. A complete version of the MHRA presentation can be found here.
In comparison to 2015, the MHRA increased the number of inspections from 303 to 324, with overseas inspections increasing from 79 to 82. The deficiencies are categorized into 10 groups with Quality Systems having the highest number of observations (38 critical and 449 major) for 2016, which was also the case for 2015.
Deficiencies relating to Data Integrity and Documentation were cited within the 2016 MHRA Inspectorate Trend Analysis (for laboratory and non-laboratory areas). The following are some examples:
- Non-contemporaneous recording was noted during placebo manufacture, as the date completed for the process step on the batch production record had already been entered before that process step had completed.
- A photocopy of a batch sheet seen in the trash container was indication of an unacceptable practice of uncontrolled photocopying of pages of the batch record during use.
- The investigation relating to a data integrity failure, whereby fictitious utility monitoring data was recorded, lacked sufficient detail to demonstrate whether willful intent was suspected.
- Printouts of particle count data from HEPA filter testing were not transferred from thermal paper to non-volatile media to ensure the integrity of the record throughout the retention period.
- The sample receipt logbook in the QC laboratory was completed when a test request was received and not when the sample was received into the laboratory, which could occur several days later, therefore, sample traceability was not maintained and the data entry was not contemporaneous.
- Complaint investigations were not always documented contemporaneously.
For further information on how Lachman Consultants can assist your firm in preparation for a MHRA (or other agency) inspection, please contact Paul Mason, Ph.D. at p.mason@LachmanConsultants.com or James Davidson, Ph.D. at j.davidson@LachmanConsultants.com.