What is Qualified Person (QP)?
The Qualified Person (QP) is very important in pharmaceutical manufacturing as it ensures that medicinal products adhere to all required quality and regulatory specifications before being released in the market. Pharmaceutical regulations in most countries and especially in the European Union require this role and it is essential to the safety, efficacy, and compliance of drugs.
Definition and Regulatory Basis of a Qualified Person
A Qualified Person is a scientifically qualified individual who plays a legal role in certifying that every batch of pharmaceutical products meet all of the requirements set out by the regulations, such as Good Manufacturing Practices (GMP), approved product specifications, and quality control information.
Pharmaceutical legislation indicates that a batch of medicinal product can be sold or distributed without the QP certification, and thus, this position is a critical component of the pharmaceutical quality system.
Core Responsibilities of the Qualified Person
The Qualified Person holds critical responsibilities to ensure that every batch of pharmaceutical products meets strict quality and regulatory standards before release.
- Batch Certification: The main role of the QP is to receive the manufacturing and quality control records of every batch and raw material testing, in-process control testing and finished product testing. The QP only releases the batch on sale or distribution after the entire batch has been checked against the approved standards and specifications.
- Oversight of GMP Compliance: The QP ensures that pharmaceutical production strictly follows the GMP standards. This involves justifying manufacturing procedures, managing the production environment, and making sure that staff members adhere to the correct procedures.
- Investigation and Decision-Making on Quality Deviations: The QP evaluates any variation, out-of-specification or non-conformities in production. They decide the batches that should be released, reprocessed or rejected.
- Product Recall and Quality Complaints Management: QP leads or assists in product recall process, whenever required, and addresses quality complaints by investigating possible product failures in liaison with the quality assurance and regulatory teams.
- Regulatory Documentation and Reporting: The QP keeps a critical batch release documentation and ensures transparency during the regulatory inspections and audits.
The Importance of the QP in Pharmaceutical Manufacturing
The QP checks pharmaceutical products before they can get to the market. This role is intermediary between scientific knowledge and legal conformity as it ensures that only those products of high quality and safety will be offered.
The role safeguards the health of the population by averting the sale of poor or contaminated drugs. It also offers legal protection to manufacturers, who ensure that they fulfill their regulatory roles.
Qualified Person plays a critical role in ensuring quality and compliance of the pharmaceuticals. Our mission at Masuu Global is to advocate pharma professionals through professional advice and resources that sustain regulatory standards and safe release of medicines globally.