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1、XXX美国制药公司 Pharmaceuticals, Inc.Quality SystemDocument Title:Finished Dosage Facility Audit ChecklistIssue Date:Previous Issue Date:Document No.:Q-SOP-#Version No.:Page.:1 of 27Company Name:Facility LocationName:_Address:Dates of Audit:Audit Performed By:Purpose of Audit:BackgroundNo.ItemResponse(Inc
2、lude references to SOPs or Protocols)Have the inspection reports from local, national, orother regulatory agencies been reviewed? Have allareas of nonconformance been addressed?Was the site inspected by FDA? Was there a FDA 483issued?Is the site subject to any recent enforcement action (e.g.warning
3、letter)?Has the FDA Establishment Inspection Report (EIR)from the last FDA inspection been reviewed, and haveall areas of non-compliance been addressed?Is there a list of products manufactured at the site?Does the site have ISO certification? If yes, attach acopy of the certification.For Use Only By
4、 Affiliates of XXX美国制药公司 Pharmaceuticals, Inc.This document contains proprietary information - it must not be reproduced or disclosed to others without prior written approvalTHE USER IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE/CHANGE BEFORE USING THIS DOCUMENTXXX美国制药公司 Pharmaceuticals, Inc.Qu
5、ality SystemDocument Title:Finished Dosage Facility Audit ChecklistIssue Date:Previous Issue Date:Document No.:Q-SOP-#Version No.:Page.:2 of 27QUALITY SYSTEMNo.Item21 CFRResponse(Include references to SOPs or Protocols)Compliant(Yes/No/NA)Organizational & Management Responsibilities1Is a current org
6、anizational chart available showingreporting structure through the President of thecompany?Yes No N/A2Is there a Quality Unit and does it exist as a separateorganizational entity?211.22Yes C|No C|N/A3Does the Quality Unit fulfill both Quality Assurance(QA) and Quality Control (QC) responsibilities?2
7、11.22Yes C|No C|N/A4Does the Quality Unit alone have both authority &responsibility to approve or reject all components, drugproducts containers and closures, in-process materials,packaging materials, labeling, and drug products?211.22Yes C|No C|N/A5Does the Quality Unit have the authority toapprove
8、/reject plant, equipment, process, andprocedural changes?211.22820.100Yes No QN/A6Are inspections and test activities carried out bypersonnel independent of those responsible for thework being performed?211.22820.20Yes C|No C|N/A7Is there a formal statement of the “Quality System” or“Quality Policy”
9、 that addresses the organizationalstructure, responsibilities, procedures, processes, andresources for implementing quality management? Ifyes, attach a copy of the index of the Table of Contentsor Index of Policies.211.22820.5820.20Yes C|No C|N/A8Are all Quality Unit procedures in writing?211.22(c)Y
10、es No N/A9Are all Quality Unit responsibilities in writing?211.22(c)Yes No N/A10Are all Quality Unit procedures current and approved?(Review log of procedures)Yes No N/A11Are the procedures followed and are quality-relatedactivities recorded at the time they are performed?(Examine records to ensure
11、consistent record-keepingthat adequately documents production, sampling, andtesting/inspections)211.22Yes C|No C|N/A12Are there periodic Management Reviews of the QualitySystem?211.100211.180(e)211.192211.198(b)(2)820.20(c)Yes C|No C|N/A13Are adequate laboratory space, equipment, andqualified person
12、nel available for required testing211.22(b)Yes C|No C|N/A14If any portion of testing is performed by a contractor,has the Quality Unit inspected contractors site andverified that the laboratory space, equipment, personneland procedures are cGMP compliant?211.22Yes No QN/A15Does there appear to be a
13、sufficient number ofpersonnel to address all activities211.25Yes C|No C|N/AEmployee Orientation, Quality Awareness, and Job Training1Are there current job descriptions for personnel?211.25820.25Yes No N/A2Is there a formal documented training program?211.25820.25Yes C|No C|N/A3Is training periodical
14、ly assessed?Yes No N/A4Is there a refresher training program that includes goodmanufacturing practices?211.25820.25Yes No N/A5How often is cGMP training performed? Is cGMPtraining documented? Has cGMP training beencompleted for all personnel?211.25820.25Yes C|No C|N/AFor Use Only By Affiliates of XX
15、X美国制药公司 Pharmaceuticals, Inc.This document contains proprietary information - it must not be reproduced or disclosed to others without prior written approvalTHE USER IS RESPONSIBLE FOR CHECKING THE CURRENT ISSUE DATE/CHANGE BEFORE USING THIS DOCUMENTXXX美国制药公司 Pharmaceuticals, Inc.Quality SystemDocument Title:Finished Dosage Facility Audit
