The updated Annex 15 of the EAEU GMP came into effect on June 14, 2021, by Decision of the EEC Council No. 65. The new requirements significantly increase the workload on quality management specialists in pharma. Inpharmatis experts believe that the automation of the quality management system (QMS) will largely reduce the costs to manufacture medicine.

“It is important to note that retrospective validation is no longer allowed pursuant to Annex 15 of the EAEU GMP Rules. Any changes that could affect product quality are documented and their impact on the validation status is assessed. Personnel must be properly trained to follow the required procedures. The requirement to ensure data integrity in the pharmaceutical industry is emphasized separately. All documents must be duly approved by authorized persons,” says Konstantin Koshechkin, Head of Electronic Solutions at Inpharmatis

At the same time, the preparation, approval, and storage of all necessary documents in paper form will require more labor costs and resources, and cannot completely eliminate human errors. The implementation of advanced electronic solutions into manufacturing processes allows you to significantly optimize the resources that are necessary to comply with the EAEU GMP requirements. The Inpharmatis has many years of proven experience in the digitalization of pharmaceutical QMS in the EAEU and CIS. For example, eQMS DOT Compliance solution ensures full compliance with the most stringent regulatory requirements, including continuous validation.

According to Annex 15 of the EAEU GMP, decisions on the scope of validation and qualifications should be based on a substantiated and documented analysis of quality risks. QMS DOT Compliance pays special attention to this requirement since the system is based on the principles of documentation and risk analysis.

The new requirements also state that qualification and validation data that have been obtained from external sources can only be used if such an approach is justified and there is confidence that all the necessary control activities have been carried out throughout the data collection process. QMS DOT Compliance allows you to automate work with suppliers so that a pharmaceutical company can determine a set of requirements for all participants in a controlled process and automatically collect the necessary information.

The new GMP Annex 15 states that planning must include the life cycle of facilities, equipment, utilities, processes, and products. It is emphasized that personnel involved in qualification and validation must be properly trained and follow approved procedures. QMS DOT Compliance allows you to create a pharmaceutical quality system that meets these requirements. It contains a deviation management system, specifying the acceptance criteria, the application of quality risk management principles, and the chosen qualification and validation strategy, including re-qualification. The organizational structure of the company defines the roles of the employees and the corresponding procedures in which the personnel should be trained. At the same time, the electronic system will control the frequency itself of repeated training and the passage of extraordinary training when changes are made.

To comply with the new requirements of the Eurasian GMP, it is necessary that all qualification and validation documents are approved by persons authorized with powers that are indicated in the pharmaceutical quality system. QMS DOT Compliance allows you to set these rights and carry out electronic approval of documents, ensuring that it is approved only by an authorized person. Also, the electronic system can confirm the suitability and compliance with the internal procedures of the validation documentation provided by a third party. The opportunity has been implemented to supplement the validation protocols received from the validation service providers with the necessary documentation and test reports before their start.