Responsible Person for Good Distribution Practices
The EU GDP Guidelines require wholesale distributors to appoint a Responsible Person. M.P.C.A. International provides RP services performed by scientific degrees (preferably pharmacists) trained annually, ensuring full compliance with EU GDP guidelines and safeguarding product users.
The role of the Responsible Person
"The wholesale distributor must designate a person as Responsible Person. The RP should meet the qualifications and all conditions provided for by the legislation of the Member State concerned. A degree in pharmacy is desirable."
EU GDP Guidelines — 2013/C 343/01The European GDP Guideline of 5 November 2013 requires that wholesale distributors must appoint a RP for GDP. M.P.C.A. International provides RP services by scientific degrees (preferably pharmacists) that are fully trained on a yearly basis.
Talk to our RP specialistsTQA commitments by WDA holder
- Clear reporting line to the licence holder
- Written job description defining RP authority
- Access to all areas, sites, stores and records
- Yearly access to training facilities
- RP fulfils responsibilities personally & is continuously contactable
- RP may delegate duties but not responsibilities
What the RP is responsible for
The EU GDP Guidelines cover twelve task areas for the Responsible Person. Some must be performed personally, while others can be delegated.
Must be performed personally
- Quality management system - implementation & maintenance
- Management of authorised activities & records accuracy
- Approving any subcontracted activities impacting GDP
- Approving returns to saleable stock
- Keeping records of delegated duties
- Deciding final disposition of returned/rejected/falsified products
Can be delegated
- Initial & continuous training programmes
- Conducting self-inspections
- Recall operations for medicinal products
- Handling of customer complaints
- Ensuring supplier & customer approvals
- Compliance with national law requirements
Responsible Person & GDP
What is a Responsible Person (RP) for GDP?
What is GDP (Good Distribution Practice)?
Which GDP tasks does M.P.C.A. International handle?
Do you support companies applying for a Wholesale Distribution Authorisation?
Need a Responsible Person for GDP?
Our RP team is ready to take on the role of Responsible Person for your WDA, ensuring full EU GDP compliance, staff training and quality management system.