It is common in today’s rapidly evolving pharmaceutical sector that companies need to outsource key activities. This can be for a number of reasons including specialist expertise, specialist storage facilities, capacity of both facilities and people, cost to your organisation and time.
It is not unusual for companies to outsource storage and transportation of medicines to specialist outsource providers whilst they retain the ‘virtual’ wholesaling activities.
But what is virtual wholesaling? The MHRA define virtual wholesaling as companies who only procure (buy) or supply (sell) medicines and do not physically handle the product. The virtual wholesaler must maintain their quality management system around these activities (e.g. customer bona fides or supplier qualification and outsourced activities via written contracts).
So how does the RP ensure oversight when WDA activities are subcontracted?
“The RP must demonstrate they have at least 1 year’s practical experience of the activities authorised on the licence” – Notes for applicants and holders of a Wholesale Dealer’s Licence (WDA(H)) or Broker Registration (2023) (Guidance Note 6)
As a nominated or named RP, you must demonstrate you have suitable experience in the activities you are to be responsible for. For virtual wholesaling this would be procurement and supply but also the activities in the management of GDP subcontractors you need to utilise.
The RP for virtual wholesalers will be required to demonstrate:
- Oversight, usually via some form of audit, of GDP subcontractors such as external storage sites, transport providers and consultants
- Approval of GDP Quality Agreements paying particular attention to clauses related to outsourced activities
- Review external quality records received from the GDP subcontractor (e.g. deviation reports or complaint reports)
Therefore, an understanding of other aspects of GDP which may be subcontracted is still an expectation so that the RP can adequately oversee and manage these outsourced activities.
What should an RP consider when assessing a new or existing subcontractor?
- Quality Agreements. As mentioned in earlier blogs the agreement between the contract giver and contract acceptor is criticality important to ensure compliance and consistency in services and products. Hints and tips can be found here.
- Inventory management, especially if stock needs to be reconciled/balanced between the virtual wholesaler and the subcontractor should be reviewed regularly and ensure that unusual sales patterns, inventory discrepancies and stock adjustments have clear processes (Note: UK storage sites must also be listed on the virtual wholesalers WDA as a Third-Party Site)
- Computer system validation. It is more and more common that subcontractors may use an electronic system to manage their QMS (eQMS system) or inventory so ensure how the subcontractor has documented the systems qualification is compliant for your business and EU GDP Chapter 3.3.1 is critical to your business.
- Transportation. It is the supplier’s responsibility to ensure that products are transported according to their labelled storage requirements. If transportation is being subcontracted, then the virtual wholesaler must demonstrate how their chosen provider is managing the transport of the virtual wholesaler’s product.
Plus, many other considerations!
Outsourcing doesn’t necessarily make wholesaling easier!
If you are a RP for a virtual wholesaler, take a look at one of our upcoming RP Forums topics to keep up to date with the latest topics https://pharmacyconsulting.co.uk/rp-forum/ Alternative if you are considering starting a virtual wholesale business then contact us to see how we can help.