Good Manufacturing Practice (GMP) describes the standards that a pharmaceutical Marketing Authorisation Holder/Manufacturer must meet to ensure that the quality and integrity of the medicinal products is maintained at the release of the products, to the supply chain and through the product’s lifetime. According to EU law, the Marketing Authorisation Holder must permanently and continuously have at his disposal the services of at least one qualified person.

 

QUALIFIED PERSON (QP) QUALIFICATIONS

The Qualified Person (QP) must fulfill the demands set forth in the European Pharmaceutical Directive 2001/83, article 48, and must have appropriate competence and experience as well as knowledge of and training in Good Manufacturing Practice. The Qualified Person (QP) must also be appropriately trained before he/she takes on the role as a Qualified Person (QP). Registration and approval by Norwegian Medicines Agency is mandatory before any QP tasks can be performed.

 

DUTIES AND RESPONSIBILITIES OF THE QP

The duties and the responsibilities of the Qualified Person (QP) should be in accordance with conditions laid out in described in relevant current Good Manufacturing Practice (GMP) guidelines and European law.

Responsibilities of the Qualified Person (QP) include (but not limited to):

  • ensuring that a quality management system is implemented and maintained
  • focusing on the management of authorised activities and the accuracy and quality of records
  • ensuring that initial and continuous training programmes are implemented and maintained
  • coordinating and promptly performing any recall operations for medicinal products
  • ensuring that relevant customer complaints are dealt with effectively
  • ensuring that suppliers and customers are approved
  • approving any subcontracted activities which may have an impact on GMP
  • ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
  • keeping appropriate records of any delegated duties
  • deciding on the final disposition of returned, rejected, recalled or falsified products
  • approving any returns to saleable stock, ensuring that any additional requirements imposed on certain products by national law are adhered to
  • releasing finished products to the market

 

RESPONSIBILITY OF THE CLIENT (MAH)

The ultimate responsibility for the fulfillment of all Good Manufacturing Practice (GMP) tasks and responsibilities and the quality and integrity of the Good Manufacturing Practice (GMP) system always remains with the marketing authorisation holder.

For further information on the possibility of using Contract QP or about how Mericon can help your company optimise the quality aspects of the release of pharmaceutical products to the supply chain, please contact Már Steinsen