Qualified Person Agreement

Responsibilities and responsibilities of qualified person Q: A company was recently audited by the relevant national supervisory authority, and some of the observations made in this inspection related to the role of the PQ with respect to the quality system. For example, the Authority requested a description of the PQ`s responsibility for approving controlled documents (documents in the quality assurance system). Is this necessary in the relevant legislation of the PQ? A: The fact that the PQ is responsible for all aspects of a quality management system, particularly the approval of all types of documents, forms and reports, is now a widespread misunderstanding. Although the tasks and responsibilities of the QPs are multiple, it must be made clear that a PQ is not automatically the head of a quality management system, the head of quality assurance or the head of a quality control unit. This may be the case for small businesses, but it is often not. The PQ must then rely not only on other QPs, but also on other employees and on the quality system, including the production manager and the director of quality control. Therefore, it is the duty of the PQ to ensure that certain conditions are met, as described in Appendix 16 of the EU`s GMP Guide. European regulations and guidelines do not provide for the PQ to approve documents other than publication documentation. However, a PQ should be associated with the implementation and maintenance of the quality management system. However, the PQ is not required to implement and execute the quality system. Therefore, if a company has a quality control unit and/or a quality assurance unit with experienced and authorized employees, why should the PQ approve controlled documents? Qualified Persons Q: Are there instructions that set out enough time on a website to familiarize a QP contract with the quality assurance system? A: There are no instructions. Time spent in the field depends on the complexity of the quality assurance system.

An important aspect is the maturity and stability of the system. If the system is developed and stable, a shorter time frame may be indicated on the site, provided that the contract pre-opens on the need to inform the PQ of changes affecting the quality system. Q: Outsourcing QP Batch Release: – what are the conditions (GMP and legal)? – What experience is needed? – Are there any models already used as a reference? A: The PQ must be approved by the relevant local authority in accordance with national law.