1 – Define the Supply Chain
By defining the supply chain you are defining the physical and financial flow of the product. This is done by determining both the customers and suppliers of the organisation. The customers must be entitled to receive medicinal product and the suppliers must be possess the appropriate bona-fides to supply the medicinal product. These control measures are some of the tools used to ensure the quality and integrity of the medicinal product is maintained through the supply chain. The conventional supply of medicines was: Manufacturer – Wholesaling – Pharmacy – Patient However now the supply chain can be much more complex Manufacturer – Wholesaler 1 – Wholesaler 2 – Wholesaler 3 – Wholesaler 4 – Wholesaler 5 – Pharmacy – Patient Also, many organisation are now engaging in the process of ‘Virtual Wholesaling’ where there is a change from the convention way we might regard wholesaling of: supply – procurement – storage- export When these 4 components of wholesaling are not all performed, that is, if the wholesaler is not storing or physically holding the product, then this may be considered as virtual wholesaling. As the financial and physical flows of the product must be controlled it is essential that Quality/Finance/Supply chain to work together to ensure compliance to the GDP guidelines.2 – Implement a QMS
A Quality Management System (QMS) is used to provide documented evidence that the organisation complies to Good Distribution Practice (GDP) guidelines. The level of complexity of the QMS is directly proportional to the complexity of the organisation. However there are several processes that are a mandatory part of any GDP QMS, irrespective of the complexity such as change control, risk management, recall of medicinal product(s), falsified medicines, complaints and returns. A process approach can be utilised to implement a QMS, where the organisation is divided into a set of processes. Each process is governed by one or several procedures (SOP’s). Each procedure provides instruction on how the process is performed and a record provides documented evidence that the organisation ‘does what it says it’s doing’. From a quality perspective unless it is recorded then it didn’t happen! Verbal assurances of actions completed are not adequate.3 – Get an RP
According to Article 79 -EC Directive 2001/83 the organisation must determine a Responsible Person (RP) where the RP will be listed on the application.Key responsibilities of an RP are:
- Ensure the QMS is implemented & maintained
- Management of authorised activities & accuracy & quality of records
- Ensure initial & continuous training programs are implemented & maintained
- Coordinate & perform any recall operation
- Ensure customer complaints are dealt with effectively
- Ensure suppliers &customers are approved
- Approve any subcontracted activities that impact on GDP
- Ensure self inspection are performed and corrective actions put in place
- Keep appropriate records of any delegated duties
- Decide on final disposition of returned, rejected, recalled or falsified products
- Approve returns to saleable stock
- Ensure adherence to additional requirements imposed on certain products by national law
4 – Submit the WDA Application
A Wholesale Distribution Authorisation form AUT-F0199-15 is submitted to the HPRA. The application will be assessed and if the application is validated an on-site inspection by the HPRA will be scheduled at the wholesaling site detailed on the application form.Mandatory elements which must be submitted as part of the WDA application include:
- Letter of application
- Certificate of incorporation
- Business document from Companies Registration Office if using a trading style
- Completed application form AUT-F0199-15
- Statement on premises and equipment (may not be applicable for virtual wholesalers)
- Overview of documents and records
- Recall procedure
- Statement on quality system (including a list of procedures)
- Details relating to Responsible Person(s)
- Classification of facility size (not applicable for virtual wholesalers)
- Fee application form
- Relevant fee
- Signed declaration
5 – HPRA Inspection Prior To A Wholesale Distribution Authorisation
Prior to awarding a WDA licence to the organisation the HPRA will inspect the wholesale site for compliance to Good Distribution Practices EU Guidelines 2013/C 343/01. If a WDA is awarded following the initial inspection the organisation is subject to follow-up inspections by the HPRA also. In the past, the inspection programme consisted of routine inspections performed at a 3 year frequency. Now the HPRA has introduced a risk based approach to scheduling inspections. This can result in the inspection frequency for a wholesaling site decreasing to 5 years but it could increase to an inspection as every 6 months. The frequency of inspection by the HPRA may be reduced or increased depending on the following factors:- Good compliance history
- Changes to operations
- Post inspection follow up
