REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot93310.21518/1561-5936-2020-1-2-3-60-67Original ArticleAssessing the relationship between deviations from GMP requirements and potential quality defects of medicinal products:a survey of employees of the pharmaceutical inspectorateOrlovVladimir A.noemail@neicon.ruShestakovVladislav N.noemail@neicon.ruState Institute of Drugs and Good PracticesSaint Petersburg State Chemical Pharmaceutical Academy011220201-3606718032022Copyright © 2020,2020Introduction. In recent years, one of the fundamental issues in the field of assessing the compliance of drug manufacturers with GMP requirements has become an objective and systematic classification of GMP-deficiencies (non-conformities, deviations) according to their level of criticality. For today the information provided in regulatory documents regarding definitions of critical, major and minor (other) deficiencies is not always sufficient for using it in GMP inspection and audit practice. Despite the release of a new PIC/s guide on this topic in at the beginning of 2019, the approaches presented in it are only partly focused on determining the cause-effect relationships between the GMP non-compliance itself, potential quality defects of medicinal products and, accordingly, risks to the life and health of patients.GMPPIC/SEMAgood manufacturing practiceGMPPIC/SEAEUEMAdeficiencyinspectionqualitymedicineauthorityharmonizationriskquality defectнадлежащая производственная практикаЕАЭСнесоответствияинспектированиекачестволекарственное средстворегуляторный органгармонизациярискдефект качества1.Орлов В.А., Шестаков В.Н. Проблемы классификации несоответствий требованиям GMP: регуляторный опыт. Ремедиум. 2019;(1-2):48-54. doi: 10.21518/1561-5936-2019-01-02- 48-54. @@ Orlov V.A., Shestakov V.N. Classification issues of GMP-inspection deficiencies: regulatory practices. Remedium. 2019;(1-:48-54. doi: 10.21518/1561-5936-2019-01-02-48-54. (In Russ.)2.PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES. The Pharmaceutical Inspection Cooperation Scheme (PIC/S). Available at: https://picscheme.org/layout/document.php?id=1609 (дата обращения: 14.11.2019).3.Орлов В.А. Обзор руководства PIC/S по классификации выявляемых несоответствий требованиям GMP. Ремедиум. 2019;(3):34-39. doi: 10.21518/1561-5936-2019-03-34-39. @@ Orlov V.А. Review of pic/s guidance on classification of GMP deficiencies. Remedium. 2019;(3):34-39. doi: 10.21518/1561-5936- 2019-03-34-39. (In Russ.)4.PIC/S INSPECTION REPORT FORMAT. Pharmaceutical Inspection Co-operation Scheme. Available at: https://picscheme.org/layout/ document.php?id=137.5.Risk classification guide for drug good manufacturing practices observations. Health Canada. Available at: 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.6.Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group. European Medicines Agency. Available at: https:// www.ema.europa.eu/en/medicines/human/referrals/angiotensin- ii-receptor-antagonists-sartans-containing-tetrazole-group.7.Guideline on Training and Qualifications of GMP Inspectors. European Commission. Available at: https://www.ema.europa.eu/ en/documents/regulatory-procedural-guideline/compilation- community-procedures-inspections-exchange-information_en.pdf #%5B%7B%22num%22%3A113%2C%22gen%22%3A0%7D%2C%7B% 22name%22%3A%22XYZ%22%7D%2C153%2C544%2C0%5D.8.Procedure for handling rapid alerts and recalls arising from quality defects. Pharmaceutical Inspection Cooperation Scheme. Available at: https://picscheme.org/layout/document.php?id=1140.9.Procedure for Handling Rapid Alerts Arising from Quality Defects. European Commission. Available at: https://www.ema.europa.eu/ en/documents/regulatory-procedural-guideline/compilation- community-procedures-inspections-exchange-information_en.pdf.