Master of pharmacy as a part of third-party auditing guaranteeing safety and quality control or another opportunity of career development

Master of pharmacy as a part of third-party auditing guaranteeing safety and quality control or another opportunity of career development

Poster

Donika Kangalova
Faculty of Chemistry and Pharmacy, Sofia University "St. Kliment Ohridski ", Bulgaria

The safety of medicinal products has to be guaranteed. Adhering to the quality standards during manufacturing and quality control plays a major role in it. These principles are based on good practices e.g. Good Manufacturing Practice (GMP). Marketing Authorization Holders (MAHs) are therefore obliged to use audits to ensure that all used active pharmaceutical ingredients (APIs) comply with Good Manufacturing Practice (GMP). Within the European Union (EU), the Qualified Person (QP) of the MAH is responsible for the GMP compliance of the manufactured medicinal products. He oversees the whole manufacturing process including the used active pharmaceutical ingredients (APIs) and excipients. According to Directive 2001/83/EC of the European Parliament and the Council and EU GMP Part II (ICH Q7) audit of API Manufacturers must be performed on site by either the QP or a qualified third-party auditor assigned by the former. The accreditation by an accreditor covers exactly those requirements which a qualified person also has to prove if he wishes to accept contract auditors. The verification of the professional competence, to secure independency concerning conflicts of interests etc. is the central element of the inspection by the accreditor. An accreditation reduces the expenditure for qualification for the contract giver and for the MAH. That is why third-party auditing is of great interest to MAHs.
Key words: audit, career development, safety, quality