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21 CFR, Parts 210 and 211An Overview of the Regulations
Part 210• Status of the regulations – 210.1– Regulations set forth are “minimum”requirements!!!!– Covers manufacturing, fa...
Part 210• Applicability – 210.2– Applies to drug products for human use
Part 210• The Definitions – 210.3• This is a critical section –understand the definitions, learnthese or you will fail!• H...
Part 210 – Definitions Cont.• Batch– A specific quantity of drug/material intendedto have uniform character and qualitypro...
Part 210 – Definitions Cont.• Drug Product– Finished dosage form• Fiber– Any particulate with a length at least 3x itswidt...
Part 210 – Definitions Cont.• Drug is defined by the Act as anycompound that has effect in the diagnosis,cure, mitigation,...
Part 210 – Definitions Cont.• Manufacture, processing, packing orholding includes– Packaging and labeling, testing and qua...
Part 211• This is the “meat” of the regulations• There are 11 subparts (identified by lettersfrom A through K)• Covers all...
Subpart A – Part 211• General Provisions• 211.1 – Scope• 211.3 – Definitions• Scope– Minimum requirements– Applies to drug...
211.22• Responsibilities of QC unit• Shall be a quality control unit• They shall have the responsibility andauthority to a...
211.22• The QC unit shall have adequatelaboratory facilities• They shall have the responsibility forapproving/rejecting al...
211.25• Personnel qualifications• Everyone shall have the education,training and experience to do their jobs• Everyone who...
211.28• Wear clean clothing and protectiveapparel• Practice good sanitation and healthhabits• Limited access areas• If you...
211.34• Consultants• Shall have sufficient education, trainingand experience to advise on the subjectmatter• Records maint...
Subpart C – Part 211• 211.42 Design and construction features• 211.44 Lighting• 211.46 Ventilation, air filtration, air he...
211.42• Any building shall be maintained tofacilitate cleaning, maintenance andproper operations• Adequate space• Operatio...
211.44 and 211.46• 211.44 – Lighting• Adequate lighting provided• 211.46• Adequate ventilation• Adequate equipment for con...
211.48 - Plumbing• Potable water supplied under continuouspositive pressure• System free of defects• Potable water meeting...
211.50 and 211.52• 211.50 – Sewage and refuse• Dispose of trash, sewage and other refuse in asafe and sanitary manner• 211...
211.56 Sanitation• Facilities maintained in a clean andsanitary condition• Free of rodents, birds, insects• Shall be writt...
211.58 Maintenance• Facilities shall bemaintained in a good stateof repair
211.63 and 211.65• 211.63 - Equipment shall be ofappropriate design, adequate size andsuitably located to facilitate opera...
211.67• Equipment and utensils cleaned,maintained and sanitized often enough toprevent contamination and malfunctions• Wri...
211.68• Automatic, mechanical and electronicequipment, computers, etc. used in themanufacturing realm shall be routinelyca...
211.72 Filters• Shall not release fibers into drugproducts–If fiber releasing filters are necessary• Additional filtering ...
211.80 - General• Written procedures for receipt, sampling,approval, rejection, etc• Handle and store to prevent contamina...
211.82 – Receipt/Storage ofuntested items• Perform visual inspection forcorrectness of items, damage,contamination, etc up...
211.84 – Testing andApproval/Rejection• Each lot must be held until QC release• Sampling based upon appropriate criteria• ...
211.84 – Testing and Approval/Rejection (con’d)• Sample testing– Conduct at least one identity verification– Test componen...
211.84 – Testing andApproval/Rejection (con’d)• Any lot of components, drug productcontainers or closures that meetsapprop...
211.86 and 211.87 and 211.89• 211.86 - Use of approved components,etc• Use FIFO when possible (1stin - 1stout)• 211.87 – R...
211.94 Drug Product Containersand Closures• Shall not be reactive, additive orabsorptive as to adversely effect product• P...
211.100 Written procedures;deviations• Have written procedures for productionand process controls to ensure drugproducts h...
211.101 Charge-in of Components• Each batch formulation should attempt tomake 100% of specified active ingredient• When a ...
211.101 Charge-in ofComponents (con’d)• Supervision of weighing operations– QC released component– Weight or measurement i...
211.103 Calculation of Yield• Actual yields and percentages oftheoretical yields shall be determined atthe end of each app...
211.105 Equipment Identification• All containers, processing lines, majorequipment used during production shall beidentifi...
211.110 Sampling and testing ofin-process materials and drug products• Procedures shall indicate in-processcontrols and te...
211.110 Sampling and testing ofin-process materials and drug products• In-process specifications shall beconsistent with f...
211.111 Time Limitations• When appropriate, time limitations forcompleting each phase shall beestablished. Deviation from ...
211.113 Control of microbiologicalcontamination• Appropriate written procedure forpreventing microorgansims in drugproduct...
211.115 Reprocessing• Written procedure describing a system forreprocessing non-conforming batches andsteps taken to ensur...
Subpart G – Packaging andLabeling Control• 211.122 Materials examination and usagecriteria• 211.125 Labeling issuance• 211...
211.122 Materials examinationand usage criteria• Written procedures for receipt, ID, storage,handling, sampling, testing, ...
211.122 Materials examinationand usage criteria (con’d)• Destroy obsolete and outdated materials• Gang printing is prohibi...
211.125 Printing Issuance• Must use strict control when issuing• Compare issued materials to master• Reconcile quantities(...
211.130 Packaging andLabeling Operations• Physically or spatially separate materials toprevent mix-ups or cross-contaminat...
211.132 Tamper-ResistantRequirements for OTCs• All OTCs for retail sale except for throat lozenge,dermatological, insulin ...
211.132 Tamper-ResistantRequirements for OTCs• Prominent statement indicating to consumer thetamper-resistant feature and ...
211.132 Tamper-ResistantRequirements for OTCs (con’d)• OTCs subject to NDA requirements andmust notify FDA of packaging ch...
211.134 Drug Product Inspection• Packaged and labeled product should befinal inspected to assure correct labeling• A sampl...
211.137 Expiration Dating• Expiration date determined by stabilitytesting• Related to storage conditions on labelingdeterm...
211.137 Expiration Dating (cond’)• Homeopathic drugs are exempt• Allergenic extracts labeled “No U.S.Standard of Potency” ...
211.142 Warehousing• Drug products must be quarantined priorto QC release• Storage conditions must not affect drugproducts...
211.150 Distribution• Oldest products are distributed first.Deviation is permitted if it is temporary andappropriate• Syst...
211.160• Specs, standards, sampling plans, testprocedures and any changes will bereviewed by the quality unit• Deviations ...
211.165• Each batch shall meet final specs prior torelease• Lots free of objectionable microorganisms• Sampling and testin...
211.166• Stability shall be done• Results shall be used to determine storageconditions and expiry dates• Written program i...
211.170• Reserve samples shall be taken• Representative of each lot• Twice the quantity for full battery of tests• Final p...
211.173 and 211.176• 211.173 Lab animals maintained andcontrolled• 211.176– Penicillin controlled in separate facility
211.180 General Requirements• Retain docs at least 1 year after the expirydate or certain OTCs, 3 years afterdistribution•...
211.182 and 211.184• 211.182 - Records of major equipmentcleaning, maintenance (except routine)and use shall be documented...
211.186• Master records maintained• Made by one person and checked by another(prepared, dated, signed – full signature)• N...
211.188• Batch records maintained for each lot• Include– Dates– Who did the work?– RM lot #– Weights used– Any test result...
211.192• Records reviewed by the quality unit• Issues resolved• Investigations performed• “The investigation shall extend ...
211.194• Lab records include complete data from alltests– Description of sample received– Statement of each method– Comple...
211.196 and 211.198• 211.196 - Distribution records maintained– who, where, what, quantity• 211.198 – Complaint files main...
211.204• Returned products identified and held• If conditions of return or storage are indoubt, investigation is warranted...
211.208• Product subjected to improper storageconditions due to disaster or accident shallnot be salvaged• Unless,– Tests ...
The EndAny questions???Troy@compliance-insight.comwww.Compliance-Insight.com513-860-3512
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21 cfr, parts 210 211

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Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/

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21 cfr, parts 210 211

  1. 1. 21 CFR, Parts 210 and 211An Overview of the Regulations
  2. 2. Part 210• Status of the regulations – 210.1– Regulations set forth are “minimum”requirements!!!!– Covers manufacturing, facilities and controlsfor• Manufacturing, processing, packaging or holding ofa drug product– Failure to comply will render the drug to beadulterated• The person who is responsible for the failure tocomply shall be subject to regulatory action
  3. 3. Part 210• Applicability – 210.2– Applies to drug products for human use
  4. 4. Part 210• The Definitions – 210.3• This is a critical section –understand the definitions, learnthese or you will fail!• Here are some:–Act means the Federal Food, Drugand Cosmetic Act
  5. 5. Part 210 – Definitions Cont.• Batch– A specific quantity of drug/material intendedto have uniform character and qualityproduced under a single manufacturing orderform during the same cycle of manufacture.• Component– Any ingredient intended for use INCLUDINGthose that may not appear in such drugproduct
  6. 6. Part 210 – Definitions Cont.• Drug Product– Finished dosage form• Fiber– Any particulate with a length at least 3x itswidth• Active ingredient– Any component intended to furnishpharmacological activity
  7. 7. Part 210 – Definitions Cont.• Drug is defined by the Act as anycompound that has effect in the diagnosis,cure, mitigation, treatment or prevention ofdisease or to affect the structure orfunction of the body of man or animals• In-process material– Any material fabricated, compounded,blended or derived for use in the drugproduct.
  8. 8. Part 210 – Definitions Cont.• Manufacture, processing, packing orholding includes– Packaging and labeling, testing and qualitycontrol of drug products• Quality Control– Any person or unit designated by the firm tobe responsible for duties relating to QC• Representative Sample– Samples drawn on rational criteria intended toaccurately portray the material being sampled
  9. 9. Part 211• This is the “meat” of the regulations• There are 11 subparts (identified by lettersfrom A through K)• Covers all sections of operations• Designed to be all encompassing(general) – DON’T expect too manyspecifics• The goal is to tell you what to do, not howto do it!
  10. 10. Subpart A – Part 211• General Provisions• 211.1 – Scope• 211.3 – Definitions• Scope– Minimum requirements– Applies to drugs for human use• Definitions– Those set forth in 210.3 are applicable
  11. 11. 211.22• Responsibilities of QC unit• Shall be a quality control unit• They shall have the responsibility andauthority to approve or reject allcomponents, containers, closures, in-process materials, packaging material,labeling and drug products• Authority to review production records• If errors have occurred, that they havebeen fully investigated
  12. 12. 211.22• The QC unit shall have adequatelaboratory facilities• They shall have the responsibility forapproving/rejecting all procedures orspecifications impacting the quality of thedrug product• Responsibilities shall be in writing andshall be followed
  13. 13. 211.25• Personnel qualifications• Everyone shall have the education,training and experience to do their jobs• Everyone who supervises those peopleshall have the education, training andexperience to assign functions to provideassurance for drug quality• There shall be an adequate number ofqualified personnel
  14. 14. 211.28• Wear clean clothing and protectiveapparel• Practice good sanitation and healthhabits• Limited access areas• If you are sick – do you belong in thearea?
  15. 15. 211.34• Consultants• Shall have sufficient education, trainingand experience to advise on the subjectmatter• Records maintained stating the name,address and qualifications of consultants
  16. 16. Subpart C – Part 211• 211.42 Design and construction features• 211.44 Lighting• 211.46 Ventilation, air filtration, air heating andcooling (HVAC)• 211.48 Plumbing• 211.50 Sewage and refuse• 211.52 Washing and toilet facilities• 211.56 Sanitation• 211.58 Maintenance
  17. 17. 211.42• Any building shall be maintained tofacilitate cleaning, maintenance andproper operations• Adequate space• Operations performed in defined areas– Receipt, storage, holding, etc.– All operations• Penicillin operations in separate area
  18. 18. 211.44 and 211.46• 211.44 – Lighting• Adequate lighting provided• 211.46• Adequate ventilation• Adequate equipment for control ofenvironment – micro, dust, air-pressure• Air filtration provided
  19. 19. 211.48 - Plumbing• Potable water supplied under continuouspositive pressure• System free of defects• Potable water meeting EPA requirements(40 CFR, Part 141)• Drains of adequate size• Air break provided or back-flow prevention
  20. 20. 211.50 and 211.52• 211.50 – Sewage and refuse• Dispose of trash, sewage and other refuse in asafe and sanitary manner• 211.52 – Washing and toilet facilities• Adequate washing facilities provided• Hot and cold potable water• Soap and detergent• Air dryers or single-service towels• Easy access to working areas
  21. 21. 211.56 Sanitation• Facilities maintained in a clean andsanitary condition• Free of rodents, birds, insects• Shall be written procedures on cleaningschedules, methods, equipment andmaterials• Shall be written procedures forrodentcides, insecticides, fungicides.• Prevent contamination
  22. 22. 211.58 Maintenance• Facilities shall bemaintained in a good stateof repair
  23. 23. 211.63 and 211.65• 211.63 - Equipment shall be ofappropriate design, adequate size andsuitably located to facilitate operations,cleaning and maintenance• 211.65 – Equipment constructed to not bereactive with product• Lubricants/coolants shall not come intocontact with product to alter their quality
  24. 24. 211.67• Equipment and utensils cleaned,maintained and sanitized often enough toprevent contamination and malfunctions• Written procedures for cleaning andmaintenance of equipment and utensilsused within the manufacturing processarena• Maintenance, cleaning, sanitizing andinspection records
  25. 25. 211.68• Automatic, mechanical and electronicequipment, computers, etc. used in themanufacturing realm shall be routinelycalibrated, checked and inspected per awritten program with retained records ofcalibrations, inspections, etc• Change controls, input/output verification,back-ups
  26. 26. 211.72 Filters• Shall not release fibers into drugproducts–If fiber releasing filters are necessary• Additional filtering using 0.22 micron maxporosity• 0.45 if manufacturing conditions so dictate–Use of asbestos-containing filter isallowed only after proving to FDA safetyor effectiveness is not compromised
  27. 27. 211.80 - General• Written procedures for receipt, sampling,approval, rejection, etc• Handle and store to prevent contamination• Bagged or boxed items shall be stored offof the floor and be adequately space forcleaning and inspection• Each container of items will be ID’d withcode for each lot received and status(quarantined, approved, rejected)
  28. 28. 211.82 – Receipt/Storage ofuntested items• Perform visual inspection forcorrectness of items, damage,contamination, etc uponreceipt• Items will be quarantined untilinspected and released
  29. 29. 211.84 – Testing andApproval/Rejection• Each lot must be held until QC release• Sampling based upon appropriate criteria• Samples– Cleaned where necessary– Obtained in a way to prevent contamination– Sterile equipment when necessary– No compositing of subdivided samples– Samples ID’d with lot #, container, date, etc– Containers must show samples were taken
  30. 30. 211.84 – Testing and Approval/Rejection (con’d)• Sample testing– Conduct at least one identity verification– Test components for conformity to specifications (C ofA is OK)– Test containers and closures for conformity tospecifications (C of T is OK)– Microscopic test of components if appropriate– Establish contamination spec if item subject tocontamination– Conduct microbiological tests on items thatmicrobiological contamination is objectionable
  31. 31. 211.84 – Testing andApproval/Rejection (con’d)• Any lot of components, drug productcontainers or closures that meetsappropriate specifications of identity,strength, quality, purity and related testsmay be approved and released for use.Any lot of such material that does notmeet such specifications shall be rejected
  32. 32. 211.86 and 211.87 and 211.89• 211.86 - Use of approved components,etc• Use FIFO when possible (1stin - 1stout)• 211.87 – Retesting of approvedcomponents, etc– After storing for a long time– After exposure to air, heat or other conditionsthat may adversely affect quality• 211.89 Rejected components, etc• ID and quarantine to prevent use
  33. 33. 211.94 Drug Product Containersand Closures• Shall not be reactive, additive orabsorptive as to adversely effect product• Provide protection from external factorsthat could contaminate or deteriorate drug• Clean and suitable for use (sterilize, etc)• Written standards, test methods to befollowed (includes cleaning, sterilizationand non-pyrogenation)
  34. 34. 211.100 Written procedures;deviations• Have written procedures for productionand process controls to ensure drugproducts have specified identity, strength,quality and purity. Approval by QA/QC unit• These procedures shall be followed andthe execution of production and processcontrol functions shall be recorded at timeof completion. Deviations shall berecorded and justified.
  35. 35. 211.101 Charge-in of Components• Each batch formulation should attempt tomake 100% of specified active ingredient• When a component is transferred to anon-original container, it shall indicate– Name, item code– Receiving or control number– Weight or measurement in new container– Batch for which component was issuedincluding name, strength and lot number
  36. 36. 211.101 Charge-in ofComponents (con’d)• Supervision of weighing operations– QC released component– Weight or measurement is correct per batchrecord– Containers are properly identified• Each component added to a batch willhave verification by a second person
  37. 37. 211.103 Calculation of Yield• Actual yields and percentages oftheoretical yields shall be determined atthe end of each appropriate phase ofproduction. Calculations will be verifiedindependently by a second person
  38. 38. 211.105 Equipment Identification• All containers, processing lines, majorequipment used during production shall beidentified to indicate contents of batch,and phase, if necessary• Major equipment shall be uniquelyidentified and shown in the batch record toindicate the specific equipment used
  39. 39. 211.110 Sampling and testing ofin-process materials and drug products• Procedures shall indicate in-processcontrols and tests in order to validateperformance and monitor output, including– Tablet or capsule weight variation– Disintegration time– Adequacy of mixing to assure uniformity– Dissolution time and rate– Clarity, completeness or pH of solutions
  40. 40. 211.110 Sampling and testing ofin-process materials and drug products• In-process specifications shall beconsistent with final specifications• In-process materials tested for ID, quality,strength and purity and be accepted orrejected by QC• Rejected material shall be quarantined inorder to prevent use in manufacturing
  41. 41. 211.111 Time Limitations• When appropriate, time limitations forcompleting each phase shall beestablished. Deviation from time limits isacceptable if quality is not compromised.Deviations shall be documented andjustified
  42. 42. 211.113 Control of microbiologicalcontamination• Appropriate written procedure forpreventing microorgansims in drugproducts not required to be sterile• Appropriate written procedures forpreventing microorganisms in sterilizeddrug products. These procedures shallinclude any sterilization process
  43. 43. 211.115 Reprocessing• Written procedure describing a system forreprocessing non-conforming batches andsteps taken to ensure reprocessedbatches conform to standards and specs• Reprocessing will not occur without reviewand approval of QC
  44. 44. Subpart G – Packaging andLabeling Control• 211.122 Materials examination and usagecriteria• 211.125 Labeling issuance• 211.130 Packaging and labeling operations• 211.132 Tamper-resistant packagingrequirements for OTC human drug products• 211.134 Drug product inspection• 211.137 Expiration dating
  45. 45. 211.122 Materials examinationand usage criteria• Written procedures for receipt, ID, storage,handling, sampling, testing, etc. There will besampling and examining of materials• Materials not meeting specifications will berejected.• Records for each shipment will be retained(receipt, examination and accept/reject)• Labeling materials for each product will bestored separately. Access limited to authorizedpersonnel
  46. 46. 211.122 Materials examinationand usage criteria (con’d)• Destroy obsolete and outdated materials• Gang printing is prohibited unlessdifferentiated by size, shape or color• Cut labeling– Dedicate lines to each product and strength– Use electronic equipment to perform 100%inspect – or –– 100% visually using 2ndperson to verify• Printing devices will be monitored
  47. 47. 211.125 Printing Issuance• Must use strict control when issuing• Compare issued materials to master• Reconcile quantities(used+returned=issued)• All excess materials with lot number will bedestroyed• Returned materials shall be stored in a wayto prevent mix-ups• Procedures will detail control of issuance
  48. 48. 211.130 Packaging andLabeling Operations• Physically or spatially separate materials toprevent mix-ups or cross-contamination• Set aside filled but unlabeled product. ID groupto prevent mislabeling• Manufacturing history of product must beavailable via lot or control number• Batch record must reflect examination forcorrectness of labels• Packaging and labeling facilities must beinspected before and after labeling operationsand reflected in batch record
  49. 49. 211.132 Tamper-ResistantRequirements for OTCs• All OTCs for retail sale except for throat lozenge,dermatological, insulin and dentifrice productsmust be tamper-resistant else consideredadulterated• Tamper-resistant products have one or morebarriers or indicators that show visible evidenceof breached integrity– Two-piece hard gelatin capsules require two tamper-resistant packaging unless capsules are sealed by atamper-resistant means– A minimum of one tamper-resistant feature is requiredeven for sealed, two-piece gelatin capsules
  50. 50. 211.132 Tamper-ResistantRequirements for OTCs• Prominent statement indicating to consumer thetamper-resistant feature and will still be visible ifthe feature is breached or missing• “Request for Exemption from Tamper-ResistantRule” petition– Name of drug product or drug class– Reason for exemption– Alternatives or step taken for reducing tampering– Other information justifying an exemption
  51. 51. 211.132 Tamper-ResistantRequirements for OTCs (con’d)• OTCs subject to NDA requirements andmust notify FDA of packaging changes• This section does not affect anyrequirements for “special packaging”under the Poison Prevention PackagingAct of 1970
  52. 52. 211.134 Drug Product Inspection• Packaged and labeled product should befinal inspected to assure correct labeling• A sampling of units shall be collected andinspected for correct labeling• Results of inspection shall be recorded inbatch record
  53. 53. 211.137 Expiration Dating• Expiration date determined by stabilitytesting• Related to storage conditions on labelingdetermined by stability testing• Products to be reconstituted must have anexpiration date for both reconstitution andunreconstitution• Expiration dates must be on labeling
  54. 54. 211.137 Expiration Dating (cond’)• Homeopathic drugs are exempt• Allergenic extracts labeled “No U.S.Standard of Potency” are exempt• New products for investigational use areexempt provided they meet stabilityspecifications in their clinical investigations• OTCs are exempt if labeling does nothave dosage and are stable for threeyears
  55. 55. 211.142 Warehousing• Drug products must be quarantined priorto QC release• Storage conditions must not affect drugproducts adversely (light, temperature,humidity)
  56. 56. 211.150 Distribution• Oldest products are distributed first.Deviation is permitted if it is temporary andappropriate• System must be in place to readily recalldistributed product if necessary
  57. 57. 211.160• Specs, standards, sampling plans, testprocedures and any changes will bereviewed by the quality unit• Deviations recorded and justified• Lab controls – scientifically sound– Determine conformance to specs• Components• In-process• Sampling– Calibration done
  58. 58. 211.165• Each batch shall meet final specs prior torelease• Lots free of objectionable microorganisms• Sampling and testing described in SOPs• Accuracy, sensitivity, specificity andreproducibility of test methods establishedand documented• Lots not meeting spec are rejected
  59. 59. 211.166• Stability shall be done• Results shall be used to determine storageconditions and expiry dates• Written program includes:– Sample size, test intervals– Storage conditions– Reliable, meaningful and specific test methods
  60. 60. 211.170• Reserve samples shall be taken• Representative of each lot• Twice the quantity for full battery of tests• Final product• API
  61. 61. 211.173 and 211.176• 211.173 Lab animals maintained andcontrolled• 211.176– Penicillin controlled in separate facility
  62. 62. 211.180 General Requirements• Retain docs at least 1 year after the expirydate or certain OTCs, 3 years afterdistribution• All docs shall be readily available for review• Docs can be copied• Data shall be evaluated at least annually• Procedures established to assure thatmanagement are notified of investigations,recalls and FDA issues
  63. 63. 211.182 and 211.184• 211.182 - Records of major equipmentcleaning, maintenance (except routine)and use shall be documented• 211.184 – Records shall be made oncomponents, containers, closures andlabeling– Name of supplier, supplier lot #, receivingcode and date received– Results of tests, individual inventory
  64. 64. 211.186• Master records maintained• Made by one person and checked by another(prepared, dated, signed – full signature)• Name & strength, dosage form• Name and weight measure of API, total weightof each dosage unit• Complete list of components• Accurate statement of weights, reasonablevariations• Theoretical reconciliation
  65. 65. 211.188• Batch records maintained for each lot• Include– Dates– Who did the work?– RM lot #– Weights used– Any test results– Inspections– Yields– Specimens of labeling– Sampling performed– Any investigations made
  66. 66. 211.192• Records reviewed by the quality unit• Issues resolved• Investigations performed• “The investigation shall extend to otherbatches … that may have beenassociated with the specific failure ordiscrepancy”
  67. 67. 211.194• Lab records include complete data from alltests– Description of sample received– Statement of each method– Complete record of all data – graphs, charts– Initials of person doing test and dates– Initials of person checking and dates– Calibration data maintained– Stability records maintained
  68. 68. 211.196 and 211.198• 211.196 - Distribution records maintained– who, where, what, quantity• 211.198 – Complaint files maintained– Investigations performed– Include name of product, lot number, name ofcomplainant, nature of complaint, reply
  69. 69. 211.204• Returned products identified and held• If conditions of return or storage are indoubt, investigation is warranted• Procedures shall be in writing
  70. 70. 211.208• Product subjected to improper storageconditions due to disaster or accident shallnot be salvaged• Unless,– Tests can show everything is OK– Evaluation of conditions indicates product wasnot exposed to such harsh conditions
  71. 71. The EndAny questions???Troy@compliance-insight.comwww.Compliance-Insight.com513-860-3512

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