A Qualified Person (QP) is a pharmaceutical professional who is legally responsible for certifying batches of medicinal products before they are released for sale or clinical trials. QPs have a deep understanding of pharmaceutical law, quality systems, as well as Good Manufacturing Practices (GMP) and Good Distributions practices (GDP). They play a vital role in protecting public health by ensuring that medicines are safe, effective, and of high quality.
In Switzerland, the Qualified Person is called the “Fachtechnisch verantwortliche Person” (FvP). To become an FvP, an academic qualification is needed, usually a degree in pharmacy. FvP are approved by Swissmedic, and are named on the pharmaceutical establishment license. The requirements for a Qualified Person are described in art. 5, art. 10, art. 14 and art. 15 of the Ordinance on Establishment Licences (MPLO).
QPs are typically employed by pharmaceutical companies, but they may also work for contract manufacturing organizations, research institutions, or regulatory agencies. To become a QP, individuals must have a degree in pharmacy or a related field, as well as several years of experience in pharmaceutical manufacturing or quality control.
QPs have a wide range of responsibilities, including:
- Overseeing the manufacturing process to ensure that GMP standards are met
- Interface to the regulatory authorities
- Reviewing and approving batch documentation
- Certifying batches of medicinal products for release
- Investigating and reporting on any quality issues
- Providing expert advice on pharmaceutical quality and regulatory compliance
- Review and approval of GxP relevant SOPs.
