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MINPROMTORG OF RUSSIA

MINPROMTORG OF RUSSIA. SID & GP. IV ALL-RUSSIA GMP CONFERENCE. Corporate Communication Center. 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. Rozhdestvensk i y , Candidate of Medical Science

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MINPROMTORG OF RUSSIA

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  1. MINPROMTORG OF RUSSIA SID & GP IV ALL-RUSSIA GMP CONFERENCE Corporate Communication Center 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

  2. 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 relevantacceptance 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:

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

  4. QUALITY OF THE DRUG PRODUCT: WHEN AND HOW IS IT CHECKED? (1) SUPRANATIONALLEVEL

  5. QUALITY OF THE DRUG PRODUCT: WHEN AND HOW IS IT CHECKED? (2) NATIONALLEVEL

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

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