FDA对XXX美国制药公司 Pharmaceuticals检查表

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

6、 organizational 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) responsibiliti

7、es?211.22Yes 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 t

8、oapprove/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

9、 Policy” 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?21

10、1.22(c)Yes 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

11、 ensure 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, andqualifie

12、d personnel 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

13、to be a 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 pe

14、riodically 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 Affiliat

15、es 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.Quality Sys

16、temDocument Title:Finished Dosage Facility Audit ChecklistIssue Date:Previous Issue Date:Document No.:Q-SOP-#Version No.:Page.:3 of 27No.Item21 CFRResponse(Include references to SOPs or Protocols)Compliant(Yes/No/NA)6Are employees trained on the Quality PolicyYes No N/A7Is job-specific training, inc

17、luding safety considerations,conducted for operators and analysts? Is it properlydocumented?Yes No N/A8Are Quality Unit supervisory and other personnel (e.g.chemists, analysts, laboratory technicians) qualified byway of training and experience?Yes C|No C|N/A9Are all employees may aware of defects wh

18、ich mayoccur from improper performance of their respectivejobs?211.25820.25Yes C|No C|N/A10If special clothing is necessary, is it described in awritten policy with an established frequency of change?211.25820.25Yes dNo C|N/A11Do personnel comply with any requirement for haircoverings or special clo

19、thing, or protection in thevarious manufacturing, packaging, and testing areas?Yes C|No C|N/A12Is there a policy for restriction of smoking, eating,drinking, chewing, and storage of food to designatedareas separate from the manufacturing and testingareas?211.25820.25Yes C|No C|N/A13Is there sufficie

20、nt assurance that consultants havesufficient education, training, and experience to adviseon the subjects for which they are retained? Are thereCurriculum Vitas (CVs) and qualifications forconsultants on file?211.34Yes C|No C|N/A14Are records kept of subjects on which the consultant(s)advised?211.34

21、Yes No N/A15Does there appear to be sufficient number of personnelto address all of the functions?211.25820.20Yes C|No C|N/A16Are personnel in contact with drugs given physicalinspections or periodic health checks?211.28Yes C|No C|N/A17Is there a procedure for exclusion of ill personnel, orpersonnel

22、 who have open lesions, from product contactjobs?211.29820.20Yes C|No C|N/ADevelopment and Design Control1For projects relating to new or modified products,service or processes, is there a written plan thatidentifies each activity required and the personresponsible?Yes No N/A2In the design of items,

23、 is appropriate input obtained anddocumented to assure proper development andapproval?Yes C|No C|N/A3In the design development process, are there reviewsafter each phase?Yes C|No C|N/A4Does the design review address each of the followingitems:Yes C|No C|N/A5a) Comparison of customer needs withtechni

24、cal specifications for materials,products, and processes?Yes No QN/A6b) Validation of the design throughprototype/lab scale tests?Yes No QN/A7c) Ability to perform under expectedconditions of use and environments?Yes C|No C|N/A8d) Considerations of unintended uses andmisuses?Yes C|No C|N/A9e) Safety

25、 and environmental compatibility?Yes No N/A10f) Compliance with regulatory requirements,national and international standards, andcorporate practices?Yes No N/A11g) Comparisons with competitive design(s)?Yes No N/A12h) Comparison with similar designs, especiallyanalysis of internal and external probl

26、emYes No N/AFor Use Only By 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

27、药公司 Pharmaceuticals, Inc.Quality SystemDocument Title:Finished Dosage Facility Audit ChecklistIssue Date:Previous Issue Date:Document No.:Q-SOP-#Version No.:Page.:4 of 27No.Item21 CFRResponse(Include references to SOPs or Protocols)Compliant(Yes/No/NA)history to avoid repeating problems?13i) Reliabi

28、lity, serviceability, andmaintainability?Yes C|No C|N/A14j) Permissible tolerances and comparison withprocess capabilities?Yes C|No C|N/A15k) Product acceptance/rejection criteria?Yes No N/A16l) Ease of installation, ease of assembly,storage needs, shelf-life, and disposability?Yes No N/A17m) Benign

29、 failure and fail-safe characteristics?Yes No N/A18n) Failure modes and effects analyses, andfault tree analysis?Yes No N/A19o) Ability to diagnose and correct problem?Yes No N/A20p) Manufacturability of the design, includingspecial process needs, mechanization,automation, assembly, and installation

30、 ofcomponents?Yes No N/A21q) Capability to inspect and test the design,including special inspection and testrequirements?Yes C|No C|N/A22r) Specification of materials, components, andsubassemblies, including approvedsuppliers?Yes C|No C|N/A23s) Packaging, handling, storage, and shelf-liferequirement

31、s?Yes C|No C|N/A24t) Safety factors relating to incoming andoutgoing items?Yes C|No C|N/A25Is there a formal design verification procedure(including clinical investigation information) toconfirm that the formalized, desired design output isadequate for its intended use?Yes No N/A26Is there a procedu

32、re to assure the design of componentsis correctly translated into production documents?Yes C|No C|N/A27Is there a procedure to assure that the first threeproduction lots are tested under actual or simulated useconditions?Yes C|No C|N/A28Is there a similar fitness for use procedure to testchanges mad

33、e in the device or manufacturing process?Yes C|No C|N/A29Is there a market readiness review before launch thataddresses the following:Yes C|No C|N/A30a) Availability and adequacy of installation,operation, maintenance, and repairmanuals?Yes C|No C|N/A31b) Existence of an adequate distribution andcus

34、tomer service organization?Yes C|No C|N/A32c) Training of field personnel?Yes No N/A33d) Availability of spare parts?Yes No N/A34Is there a design history record for each design thatdemonstrates it was developed in accord with allrequirements?Yes No N/A35Is there a sufficient number of people to add

35、ress allactivities?Yes C|No C|N/ADeviations, Failures, and CAPA1Are discrepancies that occurred during manufacturing,packaging, and testing (including Out-of-SpecificationOOS results) properly investigated?Yes No N/A2Are corrective actions taken and documented?Yes No N/A3Is there a procedure that de

36、scribes failureinvestigations?Yes No N/A4Is there a procedure that describes the acceptancecriteria or decisions covering OOS results and rationaleYes C|No C|N/AFor Use Only By Affiliates of XXX美国制药公司 Pharmaceuticals, Inc.This document contains proprietary information - it must not be reproduced or

37、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 ChecklistIssue Date:Previous Issue Date:Document No.:Q-SOP-#Versio

38、n No.:Page.:5 of 27No.Item21 CFRResponse(Include references to SOPs or Protocols)Compliant(Yes/No/NA)for retesting?5Are all investigations documented and reviewed withinspecific timeframes?Yes C|No C|N/A6Does the investigation include an evaluation of theimpact of the results on related systems and

39、batches?Yes C|No C|N/A7When a cause is identified, is there a plan establishedfor corrective action and verification of completion?Yes C|No C|N/A8Are there procedures for notifying management in atimely manner of regulatory inspections, serious GMPdeficiencies, product defects, recalls, and complain

40、ts?Yes H|No H|N/A9How do you monitor effectiveness and closure ofcorrective actions?Yes H|No H|N/A10Does the quality unit perform product quality reviews?211.192211.198Yes C|No C|N/ADocument Control Program1Do written procedures exist governing a documentchange control system and are they being foll

41、owed?211.100820.100Yes No N/A2a) Is there a list of “current documents820.100Yes No N/A3b) Are SOPs periodically reviewed andupdated?Yes No N/A4c) Is a history of SOP revisions maintained?Yes No N/A5d) How do you ensure thatobsolete/superseded SOPs, specifications,etc. are not use?Yes No N/A6e) Is t

42、here a procedure for retention ofdocumentsYes C|No C|N/A7f) Are the documents up-to-date and areunneeded/obsolete documents removedfrom use?211.100820.100Yes C|No C|N/A8g) Are changes evaluated to determine if aregulatory submission (e.g. NDA/ANDA or510(k) Supplement) is required?314.70Yes C|No C|N/

43、A9Are adequate controls in effect to assure the currentdrawings, change notices, and specifications areavailable at the place of operation?211.100820.100Yes C|No C|N/A10Are all records reviewed for completeness, accuracy,proper recording of information and legibility? Arethere adequate cross-referen

44、ces to associateddocuments, as applicable?211.100820.100Yes C|No C|N/A11a) Does the quality unit review completedbatch product records and laboratory controlrecords for critical process steps prior torelease of final product?Yes No QN/A12b) Does the quality unit review and approvespecifications and

45、master productionrecords?Yes C|No C|N/A13c) Does the quality unit review and approveprocedures affecting the quality of the in-process or finished product?Yes C|No C|N/A14d) Does the quality unit review and approvevalidation protocols and reports?Yes C|No C|N/A15Are the documents comprehensive in co

46、ntext?211.100820.100Yes C|No C|N/A16Are production records retained for appropriate timeperiods (i.e. 1 years after product expiry)211.180820.180Yes H|No H|N/A17Is at least one copy of each document, includingobsolete documents, retained for at least the life of theproduct?211.100820.100Yes C|No C|N

47、/ARecords of Raw Materials and Packaging Materials18Are records maintained that include the name of themanufacturer, identity, quantity of each shipment ofYes No N/AFor Use Only By Affiliates of XXX美国制药公司 Pharmaceuticals, Inc.This document contains proprietary information - it must not be reproduced

48、 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 ChecklistIssue Date:Previous Issue Date:Document No.:Q-SOP-#Ve

49、rsion No.:Page.:6 of 27No.Item21 CFRResponse(Include references to SOPs or Protocols)Compliant(Yes/No/NA)each batch of raw materials, intermediates, or labelingand packaging materials, suppliers control number,number allocated on receipt, and date of receipt?19Are the results from testing and examin

50、ation of rawmaterials, intermediates, and labeling or packagingmaterials maintained?Yes C|No C|N/A20Are records tracing the use of materials available?Yes No N/A21Is documentation available showing the examinationand review of raw material and packaging and labelingmaterials?Yes No N/A22Are records

51、of the disposition of rejected raw materialsor packaging and labeling materials available?Yes dNo C|N/A23Are records for APIs with retest dates retained for atleast three years after the batch has been distributed?Yes C|No C|N/AMaster Production & Control Records24Is there a product “Master Reco

52、rd” for each productthat includes:211.186820.181820.182Yes No N/A25a) Production specifications?Yes No N/A26b) Product drawings?Yes No N/A27c) Product composition?Yes No N/A28d) Product formulation?Yes No N/A29e) Compendial references?Yes No N/A30f) Component specifications?Yes No N/A31g) Production

53、 Process specifications?Yes No N/A32h) Production Equipment?Yes No N/A33i) Special precautions?Yes No N/A34j) Production methods?Yes No N/A35k) Cleaning methods?Yes No N/A36l) Production Procedures?Yes No N/A37m) Production Environmental specifications?Yes No N/A38n) Quality assurance procedures?Yes No N/A39o) Quality assurance specifications?Yes No N/A40p) Quality assurance checks performed?Yes No N/A41q) Expected yields?Yes No N/A42r) Quality assurance a