The RP responsibilities within a wholesaler operation, involve ensuring compliance with the conditions of the license and safeguarding the quality of the medicinal products handled. They will carry out the 12 primary responsibilities as mandated by the EU GDP (2013) Guidelines.
These responsibilities are as follows:
The Responsible Person is responsible for ensuring that there are adequate procedures, processes, personnel, equipment and premises for the safe distribution of medicinal products.
The Responsible Person must ensure that the company is operating within the scope of its WDA which includes the types of activities they are licensed to carry out, and the types of medicines they are allowed to distribute. The responsible person also has a focus on good quality record keeping for all transactions.
It is the responsible person responsibility to ensure that all personal are trained prior to carry out their duties and that training is kept up to date with regular retraining.
The responsible person must ensure that all notifications of recalls are received and acted upon when necessary.
It is the responsible persons responsibility to ensure all customer complaints are recorded and investigated. The responsible person also makes the final decision in regards to the complaints.
It is the responsible person responsibility to qualify all suppliers and customers prior to carrying out any transactions and ensuring their continued approval.
The responsible person will approve all third-parties that carry out any activity which may impact on GDP such as transport, temperature mapping, pest control, etc.
A responsible person is responsible for ensuring that a self-inspection is carried out annually against the GDP guidelines and all non-compliances undergo corrective measures.
The responsible person must keep records of any duties carried out by personnel on their behalf.
The responsible person is the final arbitrator of decisions involving returned products, rejected products to be sent back to suppliers, products subject to recall and any products suspected to be falsified.
The responsible person decides if a returned item is to be destroyed or returned to saleable stocks.
The responsible person must ensure that all applicable national laws and legislation is followed. These 12 primary responsibilities are at the heart of the RP's function within the licensed premises, with the Deputy RP also in observation of these disciplines.
The role of the RP carries great responsibility in and of itself, with many things to consider and oversee during the execution of those duties. With many experienced RPs, consultants and specialists on hand, we are well acquainted with the responsibilities expected of you.
We offer consultancy advice over the phone and practical assistance - particularly if you are a new startup company.
Contact us on 0330 133 0920 for more details.
Below is a short list of blog posts associated with the work of an RP.
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