Qualified Person

Qualified Person (QP) is a term used within the pharmaceutical and biotechnology industries in the European Union (EU) and other countries to describe a professional who possesses the qualifications and expertise to oversee the quality of medicinal products. The role of a Qualified Person is critical in ensuring that the manufacturing and distribution of pharmaceuticals meet the stringent regulatory standards set forth by authorities such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Role and Responsibilities

The primary responsibility of a Qualified Person is to certify that each batch of a medicinal product is suitable for release for sale or for use in a clinical trial. This certification is based on a thorough review of the production records and an assurance that the manufacturing process complies with Good Manufacturing Practice (GMP). The duties of a QP include, but are not limited to:

• Ensuring that the production and control of pharmaceutical products comply with the relevant legislation and guidelines.
• Certifying batches of medicinal products before they are released to the market.
• Overseeing the audits of manufacturing and supply chains to ensure compliance with GMP.
• Participating in the development of quality systems and making sure they are implemented effectively.
• Reporting to regulatory authorities in case of quality issues.

Qualifications

To become a Qualified Person, an individual must have a specific educational background and professional experience. Typically, a QP must have a degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology. In addition to academic qualifications, a QP must have several years of experience in pharmaceutical manufacturing and quality assurance. The exact requirements can vary from one country to another within the EU.

Regulatory Framework

The concept of the Qualified Person is enshrined in EU legislation, specifically in Directive 2001/83/EC and Directive 2001/20/EC, which set out the Community code relating to medicinal products for human use. These directives outline the qualifications and responsibilities of QPs and are implemented in the national laws of EU member states. In countries outside the EU, similar roles exist but may have different titles and specific requirements.

Challenges and Considerations

The role of a Qualified Person is both prestigious and challenging. QPs must constantly update their knowledge to keep pace with regulatory changes, technological advancements, and new pharmaceutical practices. They must also possess strong ethical standards and the ability to make difficult decisions, often under pressure. The integrity and competence of a QP directly impact the quality and safety of medicinal products.

See Also

• Good Manufacturing Practice
• European Medicines Agency
• U.S. Food and Drug Administration
• Pharmaceutical industry
• Clinical trial