What is a Marketing Authorization?
A marketing authorization (MA) is the authorization from the European Medicines Agency (EMA) which permits a medicine to be sold in one, several, or all the European Union’s member states, depending on the type of application that has been submitted and to which agency.
What is a Qualified Person?
Under the European Law of Annex 16, a Qualified Person (QP) must be appointed to certify batches of Medicinal Product prior to use in clinical trials or prior to being released for sale or supply in the EU or for export.
The QP must be able to demonstrate that they are continuously trained on the product type, production procedures, technological advancements, and modifications to GMP as well as that they meet the requirements and conditions outlined in the legislation of the member state in which they operate. They are named on the manufacturer’s authorization, MIA, as being responsible at the authorized site (manufacturing and/or certification premises) for the authorized operations set out in the authorization. The QP(s) involved in the certification of the batch must be easily identified in the case of a quality issue or batch recall.
Responsibilities of a Qualified Person
A QPs primary responsibility is to certify batches of Medicinal products prior to use in clinical trials or prior to being released for sales of supply in the EU or for export.
Other responsibilities include
- All activities and materials comply with the MA and the principles and guidelines of GMP.
- A QMS is in place and the self-inspection program is current and active.
- The entire supply chain up to certification is documented and available and products are distributed according to GDP.
- All sites involved have been audited, comply with MA and QTA’s are in place with all records complete and endorsed by appropriate personnel, including in-process controls.
- The impact of any change to manufacture or testing has been evaluated and any additional checks completed.
- All investigations pertaining to the batch have been sufficiently completed and any ongoing complaints, investigations, or recalls do not negate the conditions for certification of the current batch.
What is a Responsible Person?
The European GDP Guideline of 5 November 2013 requires that wholesale distributors must appoint a Responsible Person (RP) for GDP. The Responsible Person oversees protecting patients from any risks brought on by subpar distribution procedures.
The RP should meet the qualifications and conditions as defined in the legislation of the member state granting the Wholesale Distribution Authorization, WDA, and must be familiar with the GDP guidelines and have knowledge of the company’s licensed activities and procedures. They must have prior expertise in managing, controlling, and overseeing the wholesale distribution of medicinal products. They must have knowledge of the product, its authorization status, serialization requirements, storage requirements, the entire supply chain, agreements with third parties, and the Quality Management System (policies and procedures). An RP is required to maintain regular GDP training.
Responsibilities of a Responsible Person
An RPs primary responsibility is to ensure compliance with the GDP regulations, which protect patients from any risks brought on by subpar distribution procedures.
Other responsibilities include:
- Ensuring compliance with the WDA and GDP requirements and regulations including the generation of accurate and complete quality records.
- Implementation and maintenance of the quality system (procedure and forms) including approving and signing applicable SOPs.
- Overseeing personnel WDA and GDP training programs.
- Coordinating recalls at the site and dealing with customer complaints effectively.
- Ensuring self-inspections are conducted and deciding the fate of returned, rejected, recalled, or falsified medicinal products.
DISCLAIMER:
The information presented within this blog is for illustration purposes only and is not to be considered professional advice. Any information related to health contained within this article is not a substitute for appropriate medical advice from licensed healthcare professionals
References
Responsible person for GDP – European GDP Association (good-distribution-practice-group.org)
aut-g0080-guide-to-attainment-of-qualified-person-status-in-ireland-v3.pdf (hpra.ie)
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