The training course was provided in the context of supporting Quality Infrastructure services in a specific sector (CALIDENA), for which in the case of Armenia the pharmaceutical production has been selected due to their importance for the wellbeing of the citizens and growth of the economy in this sector.

The training focused on best international practices in quality assurance., which are mainly derived from the requirements of the international standard applied for this purpose (ISO/IEC 17025:2017). Topics such as internal and external quality control, method validation, measurement uncertainty, risk based approach and data integrity were presented and discussed with peers. The training was conducted by Karen Darbinyan, PhD, PTB international laboratory expert and hosted conjointly by the Association of Manufacturers of Pharmaceuticals (ArPharMa) and the National Medical Regulatory Authority, the Scientific Center of Drug and Medical Technology Expertise.

Approximately 30 participants from 10 pharmaceutical producers, the National Regulatory Authority, Academia, the National Accrediation Body and the National Metrology Institute attended 3 on-site and 7 virtual training sessions, which lasted average 3-5 hours, online or on-site. The acquired knowledge will help laboratories and producers to better comply with international and regulatory requirements and be more confident in their applied quality control and assurance measures.

by Stefan Wallerath