Firstly… what is an RP?
In terms of wholesale and GDP (Good Distribution Practice, NOT Gross Domestic Product!) the letters RP stand for “Responsible Person.”
So… what is a Contract RP?
Not all holders of a WDA(H) (Wholesale Dealers Authorisation for medicines of human use) will either be capable, or desire, to be the Responsible Person for their operation, so a Contract RP is often sought.
The duties of the Contract RP are the same as a licence holding RP;
- Ensure that orders for all medicinal products are made from bona fide suppliers, and that regular, documented checks are made to ensure the supply is safe and legitimate
- Wherever possible ensure that stock levels are maintained to meet current and anticipated demands, and when a pharmacy wholesaler always prioritise the patients of the pharmacy business ahead of any wholesale activities/dealing
- See that equipment is maintained in satisfactory working order and that calibration and monitoring checks are carried out annually
- Ensure that GDP records are kept of equipment servicing, and is carried out at specified intervals to approved specified requirements
- Ensure compliance with approved procedures by all staff
- Review and as appropriate update existing master documents
- Maintain suitable premises and equipment for the handling, storage and distribution of medicinal products
- Ensure that medicinal products are supplied only to persons in possession of the appropriate authorisation for sale/supply to the public
- Maintain an identifiable trail of the movement of all medicinal products ordered /supplied for wholesale distribution
- Institute the recall procedure where a recall is advised
- Ensure that the employees are adequately trained to pursue the duties required of them and documented evidence of training is demonstrated, in advance of commencement of working within the wholesale department
- Ensure that self-inspection and audit is carried out every 6-12 months and documented, including a review of recalls, and if no recall has occurred to carry out a dummy recall procedure.
- Ensure that all records are retained for a minimum period of 5 years, either on paper or electronically, ensuring a backup is made in the latter case
- Ensure that a suitable change control system is in place, incorporating risk management principles, and be both proportionate and effective
- Arrange quality meetings that should be held at least every other month, ideally monthly, or ad hoc in the case of identified deviation or serious complaint regarding product quality. Minutes should be made and any remedial actions made as swiftly as is reasonable.
- Maintain and approve standard operating procedures (SOP) to ensure that they are current, updated regularly as necessary and are paginated (Page x of y), version controlled, dated, signed and indexed.
- Any procedures or changes in the organisation or improvements in the operation found to require change are communicated to the RP for amendment or update or addition to the Standard Operating Procedures (SOP).
As you can see the role of the RP is critical in Good Distribution Practice, and without one, you cannot operate.
How will you pick your Contract Responsible Person?
Contact us for more information on our cost effective Contract RP, Contract Deputy RP and Regulatory Consultant services. We also offer compliance support memberships to help with GDP compliance.
Consultancy need not be a dirty word.
Welcome to a new Paradigm!
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