Well it’s been nearly 9 months since my blog post introducing the Agency’s Operational Transformation project, and so it seemed a good time to provide an update as the first of a number of projects is nearing delivery - just in case you had not heard via one of our stakeholder meetings or symposia events.
The Operational Transformation project is leading the Agency to redesign, realign and improve our functions and operations to maximise the public health impact. From January 2019 onwards, the Inspectorate intends to levy the existing office-based assessment (OBA) (also known as office-based inspection) fee for inspectors’ time used to review Inspection Action Group (IAG) and Compliance Management Team (CMT) follow-up activities associated with monitoring compliance.
Daily Rate fees
The daily rate inspection fee was intended to cover the cost of inspector time involved in the planning, conduct and reporting of an inspection. Since its introduction, various changes have occurred which have had an impact on inspection compliance levels:
- supply chains have become more global
- economic pressures have driven companies to seek to reduce costs
- pharmacovigilance and electronic systems have become more complex
- changes to legislation have introduced new requirements to the regulated supply chain and clinical trials sector
This combination of factors has resulted in more complex inspection cases being referred to IAG and CMT. Such cases often require a considerable amount of inspector time to review the various Corrective and Preventative Actions (CAPA), risk assessments, investigation reports, interim update responses, and so on, to confirm the suitability of the response and the proposed actions to help bring the company back to a satisfactory level of compliance.
The Inspectorate has previously applied an additional OBA fee to charge for inspector time in completing the follow-up review work associated with an IAG or CMT referral case on an ad-hoc basis. Its use has been at the discretion of Inspectorate management and has typically been applied to the very serious IAG cases, where the company has submitted a significant amount of new documentation for review in response to inspection deficiencies.
Positive benefits for compliance
In a bid to drive improved compliance and to cover the cost of managing more resource-intensive cases, we intend to apply the existing OBA fee more broadly to ensure a transparent and consistent approach. The levy does not replace the existing arrangements for using office-based inspections for:
- pre-inspection (Day 1 of inspection)
- planned post on-site inspection work
- standalone office-based due diligence inspections
The additional fee will apply to new referrals to IAG and CMT and will be charged at the existing OBA daily rate fee using the following guideline:
- first 7 hours (or 3.5 hours for GDP inspections) of inspector time taken for reviewing inspection responses = no additional OBA fee as cost already included in daily rate inspection fee
- second and subsequent 7 hours (or 3.5 hours for GDP inspections) reviewing information = charged at existing OBA daily rate fee
By adopting this approach, we aim to encourage companies to submit high quality and well thought-through responses to avoid incurring additional fees. This in turn will reduce the amount of time inspectors need to spend on their review.
This is how we have been applying risk-based inspection principles in the past - with those sites that are able to demonstrate a good understanding of the issue and effective CAPA plans not paying additional fees, and sites demonstrating poor control with inadequate responses and actions being charged additional re-inspection and/or OBA fees.
So, the change is just formalising aspects of our existing Risk Based Inspection process and is being introduced in a bid to drive improved compliance and cover the cost of managing more resource-intensive cases.
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