In the period from February 26 to March 05, 2021, 105 employees of RIBSP were trained by participating in the process of preparing production series of inactivated QazCOVID-in vaccine against coronavirus infection with the international representatives of “UkrMedSert” by Gurzhiy R.A. on the topic of “Introductory GMP course. Production of sterile medicines”. The following topics were mastered during the training:

— Pharmaceutical quality system. Staff. Authorized Person (Qualified/Authorized Person);

— Premises and equipment (principle, general requirements). Documentation. Production of medicines (principle, validation);

—  Qualification and validation. Quality control. Outsourcing activities. Promotion, quality defects and product comments. Self-inspections (internal audits). Validation of the technological process;

— Clean rooms (requirements, air conditioning systems, air purification, qualification, requalification and system monitoring);

— Principles of production of sterile medicines. Production facilities and zones. Their classification and monitoring. Validation of aseptic production of sterile medicines;

Microbiological laboratory (premises, equipment, personnel). Marriage investigation. Dossier of the production site Site Master File. Quality control of medicines. Sampling. Control and archival samples. Further study of drug stability. Current issues of validation in a pharmaceutical warehouse (temperature mapping, temperature map of the warehouse). Cold chain;

— GMP requirements for water for pharmaceutical production and its distribution systems in the production of medicines. Qualification and validation of water treatment systems.

On 16.04.2021, following the results of the training, the participants received certificates from the certified company of “UkrMedSert”.

By admin