11. Is protective clothing (gloves, caps, masks etc.) used during the weighing operations? 12. Are the utensils used for weighing (receptacles, scales, hoppers, spatulas, pipettes etc.) properly cleaned after each use? 13. Are these utensils kept in an appropriate place which is free fromc...
Audit Checklist 1 Question Instructions/Questions Note any exceptions and comments in notebook Yes/No/NA 1.0 General Controls Does the facility and its many departments (organizational units) operate in a state of control as defined by the GMP regulations? 1.1 Organizational & Management Responsibi...
The notebook used should be a laboratory-type notebook with bound pages. the notebook should be clearly labeled as to the audit type, date, and auditor(s). Many auditors prefer to use a notebook for a single audit so it may be filed with the checklist and the final report. The ...
13.2 Documentation reconciled, complete/and sent for complete documentation audit by quality assurance: SOP. 13.3 Released for sale by a pharmacist. 14 QUALITY CONTROL LABORATORY (Good Laboratory Practice) 1 Premises: separated from production areas, Independent from Production 1 Clean: floors, walls,...
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EU cGMP Audit Checklist the authorisation of written procedures and other documents, including amendments; the monitoring and control of the manufacturing environment; plant hygiene; process validation; training; the approval and monitoring of suppliers of materials; the approval and monitoring of contract...
–中国GMP的要求：第76条的要求，质量管理部门应会同有关部门对主要物料供应商质量体系进行评估，ChineseGMP,ITEM76:Qualitydepartmenthastheresponsibilitytoperformtheaudittoassesthequalitysystemofthemainvendorwithrelateddepartments –WHOGMP第8.8条：质量管理负责人有义务协同其他部门批准能提供符合要求的起始原料和包装...
Medical Device Quality Systems Manual with 820 and QSR Audit Checklist Standard Sterile Product Manufacturing Handbook Title 21 CFR Parts 1 - End Nine Volume Set US and Canadian GMPs with ICH Q7, Q8(R2), Q9(R1), Q10 US and EU GMPs with ICH Q7, Q8(R2), Q9(R1), Q10 ...
GMP Audit Procedures This SOP describes the process of planning, performing, reporting on, and following up on various audits of your systems, such as Internal Quality audits. Example of Checklist for Batch Documentation This SOP describes identifying all documentation relevant to a production process...
audit. In addition, a comprehensive checklist for GMP audits can be used as a tool, guiding auditors through a detailed review of all relevant aspects of production, from raw material sourcing to the final product release. The GMP audit report serves as a critical document, detailing compliance...