A practical approach to RP oversight
WinnPharma provides contract Responsible Person services and GDP support tailored to the organisation, its authorisation and operational needs.
- GDP governance, quality systems and self-inspection
- Supplier and customer qualification
- Storage, transport and outsourced activity oversight
- Returns, complaints, recalls and suspected falsified medicines
Agree the role properly from the outset
Before a contract RP arrangement is agreed, the licence scope, suitability, responsibilities, availability and required appointment process need to be assessed.
- Review of the existing authorisation and operating model
- Clearly defined responsibilities and working arrangements
- Training, escalation and management review support
- Inspection preparation and evidence review
Contract RP services are subject to suitability, formal appointment, licence-holder assessment and applicable MHRA requirements. Consultancy does not replace the licence holder’s responsibilities.
