Responsible Person (RP) Services
A Responsible Person (RP) will oversee your QMS, ensuring compliance with Good Distribution Practice (GDP) guidelines and legislation. Our services include training, regulatory support and managing MHRA/EMA inspections in line with the WDA requirements.
It is the responsibility of the RP to:
- Implement and uphold Wholesale Distribution Authorisation, registering with Health Authorities for pharmaceutical product storage and distribution.
- Liaise with regulatory authorities such as MHRA, EMA and FDA.
- Ensure compliance with GDP requirements, including documentation control and storage/distribution oversight.
- Adhere to EU GDP guidelines and EU/UK Legislation.
- Provide inspection readiness and GDP auditing for competent authority assessments.
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FAQs
At Apotech, we offer full transparency on our Quality Assurance services. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Yes, we have an amazing team of consultants who work with us to perform local activities such as batch release or authoring SOPs in local languages.
As we understand each country's specificities, we can supply you with the right qualified person, according to the local regulations required.
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