“While the company or organisation has always had legal responsibility for compliance, the notice of inspection has for some been a trigger for compliance assessment instead of a continuous compliance programme being in place,” the MHRA (Medicines and Healthcare products Regulatory Agency) said in a recent notice.
The MHRA said it proceeded to conduct a detailed review of risk-based inspection models and then designed a draft model to cover all inspections. However, implementation of this model will allow the agency to place a “different emphasis within the individual elements as appropriate to the different GxPs (Good Manufacturing Practices).”
Risk assessments will be ranked and inspections prioritised for the companies with the highest risk assessment scores, the agency said. Inspections will be planned according to how much inspection resource is available in 2014.
But the MHRA also notes that the completion of a Compliance Report by MAHs (marketing authorization holders) is not mandatory, though they “should be aware that failure to submit a completed report will be assessed as a high-risk answer to all questions.”
Key factors for such reports include: Only one report should be completed for each pharmacovigilance system, products not marketed in the UK should still use a compliance report, and any time-specific data requested should cover the period 1 January 2013 to 31 December 2013.
The inspection process itself, however, “will be largely indistinguishable from that operated in recent years.” Once the risk assessment has been determined and an inspection scheduled, MAHs will be contacted and requested to complete the Summary of Pharmacovigilance Systems (SPS).
The SPS contains detailed information about how the organisation operates, which is used for inspection preparation rather than planning. “The inspection will then be undertaken as previously and will conclude as usual with a closing meeting where findings are verbally reported to MAH contacts,” according to the MHRA.
TGA Moves
The MHRA isn’t the only regulator looking to make changes to the way it inspects manufacturers. Australia’s TGA (Therapeutic Goods Administration) is now inviting medical software vendors to participate in a pilot project to facilitate reporting of adverse events by health professionals.
The project is to develop a web service to assist software vendors who wish to include access to adverse event reporting for health professionals in medical software. The project is expected to run until April 2014, after which the TGA web service will be available to software vendors at no cost.
Any company providing software to health professionals - such as general practitioners, hospital and community pharmacists, specialists and nurses - who submit reports of adverse events to medicines is welcome to participate.
Involvement in the pilot will require vendors to develop a reporting interface in the software program and to test transmission of reports using the web service from their software to the TGA in XML format.