FDA对XXX美国制药公司Pharmaceuticals检查表

1、XXX 美国制药公司 Pharmaceuticals, Inc.Quality Sys twinDocument Title：Finished Dosage Facility Audit ChecklistIssue Date:devious Issue Date:document No.:Q-SOP-#Version No.:怙xe21 of 27Company Name：Facility Location Name：_ Address：Dates of Audit：Audit Performed By:Purpose of Audit：Backgroundo.ItemResponse(In

2、clude references to SOPs or Protocols)Have the inspection reports from local, national, or other regulatory agencies been reviewed? Have all areas of nonconfornance been addressed?as the site inspected by FDA? las there a FDA 483 issued?Is the site subject to any recent enforcement action (c. g.Has

3、the FDA Establishment Inspection Report (EIR) fro the last FDA inspection been reviewed and have all areas of non-conqjliance been addressed?Is there a list of products nanufacturcd al tho site?Does the site have ISO certification? If yesr attach a copy of the certificationXXX 美国制药公司 Pharmaceuticals

4、, Inc.Quality SystemDocunent Title:Finished Dosage Facility Audit ChecklistIssue Date:Previous Issue Date：Docuiwnt No.:Q-SOP-#Version No:Page.:2 of 27QUALITY SYSTEMNo.Item21 CFRResponse仃ncludc references to SOPs or Protocols)Compliant (Yes/No/NA)Organizational & Management Responsibilities1$ a curre

5、nt organisational chart available showing reporting structure through the President of the conpany?Yes No N/A2Is there a Quality Unit and does it exist as a serrate organizational entity?211.22Yes ClNo ClN/A3oes the Quality Unit fulfill both Quality Assurance (QA) and Quality Control (QC) responsibi

6、lities?211.22Yes C|No C|N/A4Oocs the Quality Unit alone have both authority & responsibility to approve or reject all coaponents. drug products containers and closures, in-process materials, packaging materials. labeling, and drug products?211.22Yes ClNo C|N/A5Ooes the Quality Unit have the authorit

7、y to approve/reject plant, equipment process. and procedural changes?211.22 820. 100Yes ONo QN/A6Ire Inspections and test activities carried out by personnel independent of those responsible for the work being perforned?211.22820. 20Yes ClNo C|N/A7Is there a fomal statenent of the aQuality System* o

8、r Quality Policy* that addresses the organizational structure, responsibilities. procedures. processes and resources for implementing quality managesent? If yes, attach a copy of the index of the Table of Contents or Index of Policies211.22820.5820. 20Yes ClNo C|N/A8Arc all Quality Unit procedures i

9、n writing?211.22(c)Yes No N/A9Are all Quality Unit responsibilities in writing?211.22 (c)Yes No N/A10Arc all Quality Unit procedures current and approved? (Review log of procedures)Yes No N/A11re the procedures followed and are quality-related activities recorded dt the time they are perfonned? (Exa

10、mine records to ensure consistent record-keeping that adequately docuncnts production, sampling, and testing/inspections)211.22Yes ClNo ClN/A12re there periodic Management Reviews of the Quality System?211.100 211.180(e)211.192211.198(b) (2)820. 20(c)Yes ClNo C|N/A13Are adequate laboratory space equ

11、ipment and Qualified personnel available for rcQuircd testing211.22(b)Yes C|No C|N/A14f any portion of testing is performed by a contractor, has the Quality Unit inspected contractorF s site and verified that the laboratory space, equipment, personnel and procedures arc cGMP coflpliant?211.22Yes Oo

12、QN/A15Does there appear to be a sufficient number of personnel to address all activities211.25Yes ClNo CIN/AEmplcyee Orientation, Quality Awareness, and Job Training1Are there current job descriptions for personnel?211.25 820. 26Yes No N/A2s there a formal documented training program?211.25 820. 25Y

13、es ClNo ClN/A3Is training periodically assessed?Yes No N/A4Is there a refresher training program that includes good oaanufacturing practices?211.25 820. 26Yes No N/A5How often is cGMP training performed? Is cGMP training documented? Has cGMP training been conpleted for all personnel?211.25 820. 25Ye

14、s ClNo 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 disclosed to others without prior written approvalXXX 美国制药公司 Pharmaceuticals, Inc.Quality SystemDocunent Title:Finished Dosage Facility Audit Checkl

15、istIssue Date:Previous Issue Date：Docuiwnt No.:Q-SOP-#Version No:Page.:3 of 27No.Item21 CFRRosponsc (Include references to SOPs or Protocols)Cofflpli&nt (YesAo/NA)64c employees trained on the Quality PolicyYes No N/A7Is job-specific training, including safety considerations, conducted for operators

16、and analysts? Is it properlyYes No N/A8Arc Quality Unit supervisory and other personnel (cg chemists, analysts, laboratory technicians) qualified byYes C|No C|N/A9re all enployees may aware of defects which nay occur fron improper perfornance of their respective Jobs?211.25820.25Yes ClNo C|N/A10If s

17、pecial clothing is necessary is it described in a written policy with an established frequency of change?211.26820. 25Yes dNo CIN/A11Do personnel comply ltb any requirement for hair coverings or special clothing. or protection in the various manufacturing, packaging, and testing areas?Yes ClNo CIN/A

18、12Is there a policy for restriction of snoking eating, drinking, chewing, and storage of food to designated areas separate fron the tuanufacturing and testing areas?211.26820. 25Yes ClNo CIN/A13Is there sufficient assurance that consultants have sufficient education training, and experience to advis

19、e on the subjects for which they arc retained? Arc there Curriculun Vitas (CVs) and qualifications for consultants on file?211.34Yes C|No C|N/A14rc records kept of subjects on which the consultant($) advised?211. 34Yes Qio O/A15&ocs there appear to be sufficient nuaber of personnel to address all of

20、 the functions?211.25 820. 20Yes ClNo ClN/A16re personnel in contact with drugs given physical inspections or periodic health checks?211.28Yes C|No CIN/A17s there a procedure for exclusion of ill personne 1 or personnel rho have open lesions. fro product contact jobs?211.29820. 20Yes ClNo CIN/ADevel

21、opment and Design Control1For projocts relating to new or modified products, service or processes, is there a written plan that identifies each activity required and the person responsible?Yes No N/A2In the design of items. is appropriate input obtained and documented to assure proper development an

22、d approval?Yes ClNo CIN/A3In the design development process are there reviews after each phase?Yes ClNo CIN/A4Does the design review address each of the following items：Yes C|No CIN/A5a) Comparison of customer needs with technical specifications for materials, products, and processes?Yes Oo QN/A6b)

23、Validation of the design through prototype/lab scale tests?Yes Oo QN/A7c) Ability to perfom under expected conditions of use and environments?Yes ClNo ClN/A8d) Considerations of unintended uses and misuses?Yes C|No C|N/A9e) Safety and environmental compatibility?Yes No N/A10f) Compliance with regula

24、tory requirenents, national and international standards, and corporate practices?Yes No N/A11g) Comparisons with competitive design(s)?Yes No N/A12h) Comparison with similar designs, especially analysis of internal and external problemYes No N/AXXX 美国制药公司 Pharmaceuticals, Inc.Quality SystemDocunent

25、Title:Finished Dosage Facility Audit ChecklistIssue Date:Previous Issue Date：Docuiwnt No.:Q-SOP-#Version No:Page.:4 of 27No.Item21 CFRRosponsc (Include references to SOPs or Protocols)Cofflpli&nt (YesAo/NA)history to avoid repeating problens?13i) Reliability, serviceability, and maintainability?Yes

26、C|No ClN/A14j) Pernissible tolerances and comparison with process capabilities?Yes C|No C|N/A15k) Product acceptance/rejection criteria?Yes No N/A161) Ease of installation, ease of asseubly, storage needs shelf-life and disposability?Yes No N/A17d) Bonlgn failure and fail-safe characteristics?Yes No

27、 N/A18n) Failure odes and effects analyses, and fault tree analysis?Yes Ko N/A19o) Ability to diagnose and correct problea?Yes No N/A20p) Manufacturability of the design, including special process needsr Bechanization, automation. asseably. and installation of cooponents?Yes No N/A21q) Capability to

28、 inspect and test the design, including special Inspection and test requirements?Yes C|No C|N/A22r) Specification of naterials components, and subassemblies, Including approved suppliers?Yes C|No C|N/A23s) Packaging, handling, storage and shelf-life requirements?Yes C|No C|N/A24t) Safety factors rel

29、ating to inconing and outgoing items?Yes ClNo C|N/A26Is there a formal design verifiestiem procedure (including clinical investigation information) to confirn that the foralizedr desired design output is adequate for its intended use?Yes ClNo O/A26Is there a procedure to assure the design of compone

30、nts is correctly translated into production documents?Yes C|No C|N/A27Is there a procedure to assure that the first three production lots arc tested under actual or simulated uso conditions?Yes ClNo C|N/A28Is there a sinilar fitness for use procedure to test changes made in the device or nanufacturi

31、ng process?Yes ClNo ClN/A29Is there a market readiness review before launch that addresses the following：Yes ClNo ClN/A30a) Availability and adequacy of installation, operation. maintenance and repair manuals?Yes C|No ClN/A31b) Existence of an adequate distribution and customer service organization?

32、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 that deuonstrates it was developed in accord with all requirements?Yes No N/A35Is thore a sufficient nuabor of pooplo to address all activitios?Yes C

33、|No C|N/ADeviations, Failures, and CAPAiHe discrepancies that occurred during nanufacturing packaging, and testing (including OuSpecification OOSj results) properly investigated?Yes No N/A2A corrective actions taken and docuaented?Yes No N/A3Is there a procedure that describes failure investigations

34、?Yes No N/A4Is there a procedure that describes the acceptance criteria 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 disclosed to others without

35、 priorwritten approval厂 r八 i ei 广了、八 广”厂八 ,小 %*z*f厂r%riz*iriffx-rrXXX 美国制药公司 Pharmaceuticals, Inc.Quality SystemDocunent Title:Finished Dosage Facility Audit ChecklistIssue Date:Previous Issue Date：Docuiwnt No.:Q-SOP-#Version No:Page.:5 of 27No.Item21 CFRRosponsc (Include references to SOPs or Proto

36、cols)Cooipllant (YesAo/NA)for retesting?5rc all Investigations docuncntcd and reviewed within spocific timofrancs?Yes C|No C|n/A6hes the investigation include an evaluation of the impact of the results on related systems and batches?Yes C | No C | N/A7Fhen a cause is identified, is there a plan esta

37、blished for corrective action and verification of completion?Yes C | No C | N/A8Kre there procedures for notifying nkanagenent in a tincly manner of regulatory inspections, serious GMP deficiencies, product defects, recalls, and complaints?Yes H | No H | N/A9low do you nonitor effectiveness and clos

38、ure of corrective actions?Yes H | No H | N/A10kes the quality unit perfor product quality reviews?211. 192211.198Yes C | No C | N/ADocun:ent Control Program1Oo written procedures exist governing a document change control syste and are they being followed?211.100820.100Yes No N/A2a) Is there a list o

39、f * current* dxuxnls820.100Yes No N/A3b) Are SOPs periodically reviewed and updated?Yes No N/A4c) Is a history of SOP revisions maintained?Yes No N/A5d) How do you ensure that obsolete/superseded SOPs, specifications etc. arc not use?Yes No N/A6e) Is there a procedure for retention of documentsYes C

40、 | No C | N/A7f) Are the documents up-to-date and are unneeded/obsolet documents reoved from use?211.100820.100Yes C|No C|n/A8g) Are changes evaluated to detenoine if a regulatory submission (e. g. NDA/ANDA or 510(k) Suppleaent) is required?314. 70Yes C | No C | N/A9re adequate controls in effect to

41、 assure the current drawings, change notices, and specifications arc available at the place of operation?211.100820.100Yes C | No C | N/A10rc all records reviewed for completeness, accuracy, proper recording of information and legibility? Are there adequate cross-references to associated documents,

42、as applicable?211.100820.100Yes C | No C | N/A11a) Docs the quality unit review conpleted batch product records and laboratory control rocords for critical process steps prior to release of final product?Yes Oo Qn/A12b) Does the quality unit review and approve specifications and master production re

43、cords?Yes C | No C | N/A13c) Does the quality unit review and approve procedures affecting the quality of the in- process or finished product?Yes C | No C | N/A14d) Does the quality unit review and approve validation protocols and reports?Yes C | No C | N/A15re the documents conprehensive in context

44、?211.100820.100Yes C|No C|N/A16re production records retained for appropriate time periods (i. e. 1 years after product expiry)211.180820. 180Yes H | No H | N/A17Is at least one copy of each document. Including obsolete dociaents, retained for at least the life of the product?211.100820.100Yes C | N

45、o C | N/ARecords of Raw Materials and Packaging Materials18Kre records maintained that include the name of the uanufacturcr, identity, quantity of each shipnent ofYes No N/AFor Use Only By Affiliates of XXX 美国制药公司 Pharmaceuticals, Inc.This document contains propri4iry information - it must not be re

46、prcxluced or disclosed to others without prior written approvalXXX 美国制药公司 Pharmaceuticals, Inc.Quality SystemDocunent Title:Finished Dosage Facility Audit ChecklistIssue Date:Previous Issue Date：Docuiwnt No.:Q-SOP-#Version No:Page.:6 of 27No.Item21 CFRRosponsc (Include references to SOPs or Protocol

47、s)Cofflpli&nt (YesAo/NA)each batch of raw naterials, intermediates. or labeling and packaging materials. supplier s control nunber, limber allocated on receipt and date of receipt?19He the results from testing and examination of raw naterials intgcwdiBtes. and labeling or packaging naterials maintai

48、ned?Yes ClNo CIN/A20Kre records tracing the use of naterials available?Yes No N/A21Is docuBentation available shoving the exanindtion and review of raw material and packaging and labeling naterials?Yes No N/A22心e records of the disposition of rejected raw materials or packaging and labeling naterial

49、s available?Yes dNo ClN/A23Are records for APIs with retest dates retained for at least three years after the batch has been distributed?Yes ClNo ClN/A4a?terProduction & Control Records24Is there a product aMaster Record* for each product that includes：211.186820.181820.182Yes No N/A25a) Production

50、specifications?Yes No N/A26b) Product drawings?Yes No N/A27c) Product coiiposition?Yes Ko N/A28d) Product formulation?Yes No N/A29c) Cofflpcndial references?Yes No N/A30f) Component specifications?Yes No N/A31g) Production Process specifications?Yes No N/A32h) Production Equipment?Yes Ko N/A331) Spe

51、cial precautions?Yes No N/A34j) Production methods?Yes No N/A35k) Cleaning methods?Yes No N/A361) 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

52、checks perfomed?Yes Ko N/A41q) Expected yields?Yes Ko N/A42r) Quality assuranco apparatus usod?Yes No N/A43s) Packaging and Labeling specifications?Yes No N/A44t) Packaging: and Labeling nethods?Yes No N/A45u) Packaging and Labeling procedures?Yes No N/A46v) Full information on components suppliers

53、and specifications?Yes No N/A47w) Copies of critical conponent supplier agreements?Yes dNo CN/A48x) Copies of labels, labeling and associated labeling procedures (i.e. Master Labels)?Yes H|No HIN/A49y) Storage conditions?Yes No N/A50z) Shelf life Information?Yes No N/ABatch Production and Control Records51Is there a Product 41 Batch Record or Product History Record* for each batch of product in accordance with the product Master Record that includes：211.188820.184820.185Yes No N/A52a) Date and times of manufacture?Yes No N/A53b) Identity of cqulpncnt us