PHARMACEUTICALINSPECTIONCONVENTION PIC/S PHARMACEUTICALINSPECTIONCO-OPERATIONSCHEME PI 040-1 3Appendices 1January2019 PIC/SGUIDANCEON CLASSIFICATIONOFGMPDEFICIENCIES @PIC/SJanuary2019 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. Editor: PIC/S Secretariat e-mail: [email protected] web site: htto:fwww.picscheme.org PI040-1 1of 18 1January2019 TABLEOFCONTENTS Page 1. DOCUMENTHISTORY .3 2. INTRODUCTION ...3 3. PURPOSEANDSCOPE. 4. DEFINITIONS 4 5. MANAGEMENTTOOLTOSUPPORTCONSISTENTAND OBJECTIVECATEGORISATIONOFGMPDEFICIENCIES INACCORDANCEWITHRISKMANAGEMENTPRINCIPLES........5 6. ACTIONSTOBETAKENBYINSPECTORATES IN RESPONSETOTHEREPORTINGOFCRITICALAND MAJORDEFICIENCIES...... 5 7. ENHANCINGCOMMUNICATION,INFORMATIONSHARING ANDSCIENTIFICEXCHANGETOPROMOTEINCREASED CONSISTENCYANDPREDICTABILITYINREGULATORY ASSESSMENTSANDDECISIONSANDTHERAPID EXCHANGEOFSAFETYANDQUALITYINFORMATION REGARDINGMANUFACTURERS. 6 8. REVISIONHISTORY. APPENDIX 1: MANAGEMENTTOOLTOSUPPORTCONSISTENTAND OBJECTIVECATEGORISATIONOFGMPDEFICIENCIESIN ACCORDANCEWITHRISKMANAGEMENTPRINCIPLES 8 APPENDIX 2: INTERPRETATIVEGUIDANCEONRISKINCREASINGOR REDUCINGFACTORS 13 APPENDIX 3: CLASSIFICATIONEXAMPLES ..16 PI 040-1 2 of 18 1January2019