A Qualified Person (QP) declaration is a critical aspect of the pharmaceutical industry's quality assurance process. In the European Union (EU), a QP is responsible for ensuring that each batch of medicinal product complies with regulatory requirements before it is released for sale or distribution. Here's a brief overview of the QP declaration:
The QP declaration is a legally required statement made by a Qualified Person. It confirms that a particular batch of medicinal product has been manufactured, tested, and released in accordance with Good Manufacturing Practice (GMP) and meets the necessary quality standards. The QP ensures that all necessary quality control checks, including raw materials, manufacturing processes, and analytical testing, have been performed and documented.
The QP declaration includes information about the product's batch number, manufacturing and expiry dates, and the name and address of the manufacturing site. It confirms that the batch has been produced using approved procedures and under suitable conditions to maintain its quality, safety, and efficacy.
The QP's role is to review all relevant documentation, including manufacturing records, analytical results, and quality control data, to ensure compliance with applicable regulations. They also assess any significant deviations or changes in the manufacturing process that may impact product quality. The QP must be satisfied that the batch is suitable for release, and their declaration serves as a quality assurance seal.
The QP declaration is a critical step in maintaining patient safety and ensuring the integrity of medicinal products. It provides assurance that the batch has undergone rigorous quality control and meets the required standards. The QP's expertise and knowledge are essential in upholding the highest quality standards throughout the entire manufacturing and distribution process.
