Traditionally, GDP (Good Distribution Practice) inspectors visit sites to confirm that holders of Wholesale Dealer’s Authorisations (WDA) are compliant with the requirements of legislation.
Over recent years the volume of applicants for WDA’s has increased significantly which has necessitated the introduction of risk based systems to ensure GDP Inspectorate resources are used to maximum effect.
As part of this project, work began last year on developing a model for Office Based Risk Assessment (OBRA); this was intended to allow inspectors to remotely assess applications for and variations to WDA’s. Having been worked up and validated the model was introduced and is now being used for pharmacy collection sites.
Launch of the scheme
The scheme was officially launched in at the start of 2016 and is now fully bedded in. In the first six months over 200 sites were assessed, covering nine companies. Had these assessments been undertaken in the ‘conventional’ way they would have required nearly 200 GDP inspector days on site. Additionally, by assessing applications in this way the regulatory costs to applicants have been significantly reduced.
Site selection process
Assessments are initially being carried out on retail pharmacy sites that undertake the ordering and collection of medicines which are sent onto a central hub within the same organisation for onward supply to another wholesaler. In this model stock is ordered from a small number of wholesalers in excess of the pharmacy need, holding these products for a short while on the pharmacy premises and then selling on. The intention is not to use this type of assessment process to replace an actual inspection but to more adequately assess and understand the risks associated with pharmacy wholesaling sites of this type. The following criteria are used to judge suitable sites for inclusion in the programme:
- The site is undertaking limited activity: its purpose is the procurement of stock, with the stock being transferred to the company’s warehouse or head office and not directly to another customer outside the company’s ownership
- The company is known to have a good level of compliance with no major deficiencies in the last inspection cycle
- The company uses a common Quality Management System across the group and this has been assessed at inspection at the head office or central warehouse site which continues to be inspected on a normal risk based frequency.
- A GDP certificate for the site is not required – the lack of a GDP certificate does not prevent the wholesaler from trading at this site as the site is supplying the hub only
Assessment is based on three inputs, the company’s answers to questions about the size and value of its wholesaling business, the quality of the company’s procedures together with the control and conditions of the site’s holding areas. An overall risk score is derived from these scores and the next risk review assessment set, based on the risk rating achieved.
Outcomes and benefits to both stakeholders and the MHRA
This new approach helps Inspectors focus their physical site visits on higher risk activities and operations, increase coverage of the inspection universe and helps to increase trust with stakeholders whilst at the same time reducing their inspection costs. It therefore clearly demonstrates how the Inspectorate continues to find innovative ways to address challenges and thereby continue to protect public health by effectively maintaining regulatory standards.