REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot105310.21518/1561-5936-2019-3-34-39Original ArticleReview of PIC/S guidance on classification of GMP deficienciesOrlovV. A.noemail@neicon.ruFederal State Budgetary Institution «State Institute of Medicines and Good Practices»Federal State Budget Educational Institution of Higher Education «Saint Petersburg State Chemical Pharmaceutical Academy»031220193343918032022Copyright © 2019,2019The article provides an overview of the PIC/S (PI 040-1) guidance published in January 2019, which contains recommendations on classification of identified GMP deficiencies. It provides detailed diagrams containing instructions on the recommended operating procedures in case of identification of GMP deficiencies, and decision versions of final classification of such deficiencies. In addition, the authors provide regulators with valuable recommendations on the management of possible activities in response to critical and significant GMP deficiencies.PIC/SGMP deficienciesinspection of pharmaceutical manufacturersdrug qualityharmonization of regulatory requirementsdata integrityнесоответствие требованиям GMPинспектирование фармацевтического производствакачество лекарственных средствгармонизация регуляторных требованийцелостность данны1.Орлов В.А., Шестаков В.Н. Проблемы классификации несоответствий требованиям GMP: регуляторный опыт. Ремедиум. Журнал о российском рынке лекарств и медицинской техники. 2019;1:18-24.2.Risk classification guide for drug good manufacturing practices observations // Health Canada URL: https://www.canada.ca/ content/dam/hc-sc/documents/services/drugs-health-products/ compliance-enforcement/good-manufacturing-practices/ guidance-documents/risk-classification-drug-gmp-observations-0023-eng.pdf (дата обращения: 24.02.2019).3.PIC/S guidance on classification of GMP deficiencies // The Pharmaceutical Inspection Co-operation Scheme (PIC/S) URL: https://picscheme.org/layout/document.php?id=1609 (дата обращения: 24.02.2019).4.PIC/S inspection report format // Pharmaceutical Inspection Co-operation Scheme URL: https://picscheme.org/layout/ document.php?id=137 (дата обращения: 24.02.2019).5.Compilation of Community Procedures on Inspections and Exchange of Information // European Comission URL: https:// www.ema.europa.eu/documents/regulatory-procedural-guideline/ compilation-community-procedures-inspections-exchange-information_en.pdf (дата обращения: 24.02.2019).6.Good practices for data management and integrity in regulated GMP/GDP environments (Draft) // Pharmaceutical Inspection Co-operation Scheme URL: https://picscheme.org/layout/ document.php?id=1567 (дата обращения: 24.02.2019).7.Deviation Handling and Quality Risk Management (Draft) // World Health Organization uRL: https://www.who.int/ immunization_standards/vaccine_quality/risk_july_2013.pdf?ua=1 (дата обращения: 24.02.2019).