SID & GP MINPROMTORG OF RUSSIA Corporate Communication Center IV ALL-RUSSIA GMP CONFERENCE CONCEPT OF QUALITY AND APPROACHES TO ITS DEFINITION AT THE NATIONAL LEVEL AND IN THE LEGISLATION OF THE EAEU. DRUG LIFE CYCLE MANAGEMENT D.A. Rozhdestvenskiy, Candidate of Medical Science Department of Technical Regulation and Accreditation Eurasian Economic Commission

QUALITY OF DRUG PRODUCT: WHAT IS IT? Quality of a drug product is a combination of properties and characteristics of a pharmaceutical substance and a drug product, ensuring their compliance with the intended use in accordance with the requirements of acts of the Union bodies. (Decision of the EEC Council No. 78 dated November 3, 2016) Critical quality attribute (CQA) is a physical, chemical, biological or microbiological property or characteristic that, in order to ensure the required product quality, must be within the appropriate limits and range or have an appropriate distribution. (Recommendation of the EEC Board No. 19 dated September 26, 2017) Normative quality document is a document that establishes the requirements for the quality control of a drug product (containing the specification and DESCRIPTION of analytical methods and tests or references to them, as well as relevant acceptance criteria for the specified quality indicators, etc.) based on the examination of the medicinal product , approved by the authorized body during registration on the territory of the Union and is intended to control the quality of the drug in the post-registration period on the territory of the Union. Specification is a list of quality indicators, REFERENCES to analytical methods and tests and standards, which are numerical (quantitative) limits, ranges and other criteria for the specified quality indicators. (Decision of the EEC Council No. 78 of November 03,2016) General partner: Strategic partners: Official partners: Regional partners:

QUALITY OF THE DRUG PRODUCT: WHERE IS IT STANDARDIZED? SPECIFICATION SPECIFICATION DESCRIPTION OF ANALYTICAL METHOD SITE MASTER FILE SECTION 7 REGISTRATION DOSSIER MODULE 3 DESCRIPTION OF ANALYTICAL METHOD VALIDATION OF ANALYTICAL METHOD VALIDATION OF ANALYTICAL METHOD RD on quality

QUALITY OF THE DRUG PRODUCT: WHEN AND HOW IS IT CHECKED? (1) SUPRANATIONAL LEVEL DP design (QbD) Rules for the study of bioequivalence (Decision of the Council No.85 of 03.11.16) The rules for the study of biological drugs (Council Decision No.89 of 03.11.16) Validation of analytical methods (Decision of the Board No.113 of 17.07.18) Guidelines for the quality of modified dosage forms (Board Recommendation No.2 of 16.01.18) Guidance on the validation of the production process (Board Recommendation No.19 of 26.09.17 Preparation of specifications Guidelines for the preparation of regulatory quality documentation (Decision of the Board No.151 of 07.09.18) Guidelines for the quality of herbal drug products (Board Recommendation No.6 of 10.05.18 No. 6) Guidance on the selection of tests and criteria in the specification of herbal drug products (Board Recommendation No. 6 of 12.02.19) Guidelines for the quality of inhaled and nasal drugs (Board Recommendation No.17 of 07.07.18) Production EAEU GMP Rules (Council Decision No. 77 of 03.11.16) Guidelines for minimizing the risks of microbial contamination of herbal drug products (Board Recommendation No. 24 of 06.08.19) Registration Requirements for the study of stability (Decision of the Board No. 69) of 10.05.18 Volume of laboratory examination (Board Recommendation No.28 of 10.09.19) EAEU Pharmacopoeia

QUALITY OF THE DRUG PRODUCT: WHEN AND HOW IS IT CHECKED? (2) NATIONAL LEVEL STAGE OF CIRCULATION CONTROL DOCUMENT 1. Release from site into circulation Batch certificate (Certificate of analysis, Quality certificate) from a qualified person 2. Import from the external contour of the Union Test report (Monitoring by national authorized laboratories) 3. Import from the internal contour of the Union 4. Wholesale and retail sales Test report (Supervision by authorized bodies)

THANK YOU FOR YOUR ATTENTION! e-mail: rozhdestvenskiy@eecommission.org phone: +7 (495) 669-2400 (ext. 3141)