Responsible Person (RP)
The role of the Responsible Person (RP) was first mentioned in the Human Medicines Regulations 2012:
Requirement as to responsible person
45.—(1) The licence holder must ensure that there is available at all times at least one person (referred to in this regulation as the “responsible person”) who in the opinion of the licensing authority—
(a)has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate to carry out the functions mentioned in paragraph (2); and
(b) has adequate experience relating to those activities and procedures.
Further guidance on the Responsible Person (RP) roles and responsibilities was published in 2013 Chapter 2 the EU Good Distribution Practice guidelines:
The wholesale distributor must designate a person as responsible person. The responsible person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned (1). A degree in pharmacy is desirable. The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP.
A Responsible Person (RP) with a pharmacy degree is desirable, however anyone with a minimum of 1 years experience within a GDP environment may be eligible depending on their level of experience and knowledge.
The role of the Responsible Person (RP) for GDP is significant and requires excellent leadership and communication skills to ensure a smooth operation within medium and large sized enterprises.
The RP should have a direct line to the CEO, MD and other Directors and a level of authority to ensure GDP practice is adhered across the organisation.
Contract Responsible Person (RP)
Employing a Responsible Person (RP) for GDP can be financial prohibitive, especially for low turnover organisations or new startups.
A cost effective solution would be to have a Contract Responsible Person (RP).
Why not consider a Contract Responsible Person (RP) for GDP in your organisation?
Read more here.
Are you up to scratch as an RP
Have you attended any GDP / RP training?
Do you maintain your regulatory and industry knowledge by attending GDP refreshers annually?
Is your CPD up to date?
Are you comfortable with auditing for Self-inspection?
Do you have any authority within the organisation you work for?
As far as RP responsibilities are concerned this is just the tip of the iceberg!
How Pharma Experts can help
Within our team we have several experienced senior RPs with the right level of skills and knowledge to provide the following services:
- Responsible Person (RP) Training
- GDP and RP Training
- Bespoke Training (contact us to discuss your requirements)
- Audit Training (coming soon)
- Contract RP
- RP Mentoring
Training events are listed on the right hand or you can head straight to the Training Calendar.
If you prefer to have a training event at own chosen place you will find more details on the benefits of our In-house Training offer.
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial telephone consultation.