QP Declaration
Qualified Person (QP) declaration
The Declaration of a Qualified Person (QP) is a very important part of the process of quality assurance in the pharmaceutical industry. In the EU, a QP is the one who makes sure that each batch of the medicinal product meets all the necessary regulatory requirements prior to being sold. This is how it works:
The QP declaration is a legally required statement made by a Qualified Person. It is the certification that the particular batch of medicines has been manufactured, verified, and released in compliance with Good Manufacturing Practice and is of appropriate quality. It is the duty of the Qualified Person (QP) to ensure that all processes pertaining to quality assurance are completed before the release of the batch.
The statement of the Qualified Person will contain the batch number, date of manufacture, expiry date of the batch, and manufacturing site name.
This person will review all the necessary documents such as manufacturing, analyses, and quality control, to ensure adherence to all the relevant regulations. They will also evaluate any substantial variations within the manufacturing process which might affect the quality of the product. The QP should satisfy themselves that the batch is fit for release.
The Quality Pass statement is an important part of the process to keep patients safe and to ensure the integrity of drugs. The QP statement guarantees that the batch has been tested for quality. The QP’s expertise and knowledge are essential in upholding the highest quality standards throughout the entire manufacturing and distribution process.