Basics of FDA GMP Training


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The basics of FDA required GMP training. For more information go to

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Basics of FDA GMP Training

  1. 1. Basic cGMPsA Basic Overview of the US FDA’sRegulations for Regulatory ComplianceCompliance Insight, Inc.
  2. 2. Basic cGMPs• Remember, QUALITYis the responsibility ofeveryone• Don’t just make theproduct or do your joband leave it up toQuality Assurance fixthe problems
  3. 3. The Regulations• cGMP stands for “currentGood ManufacturingPractices”• Always improving andchanging (that is why theyare called “current”)• Regulations are aminimum that must be met
  4. 4. The Regulations• cGMPs are listed inthe CFR (Code ofFederal Regulations)Part 210 and 211• Part 210 - definitions• Part 211 - basicinstructions• Part 11 - electronicdata
  5. 5. Organization and Personnel• Shall have a Quality Unitwith responsibility to rejector approve all material,procedures andspecifications• Everyone will havesufficient training,knowledge and experienceto do their job
  6. 6. Organization and Personnel• Wear clean clothing• Wear protective apparel toprevent contamination• Practice good sanitation• If you are sick or have openlesions that would impact thedrug, then you will beexcluded from direct contactwith the product
  7. 7. Buildings and Facilities• Building will beadequately sized forproper storage ofequipment andmaterial• Operations will beperformed in specificareas
  8. 8. Buildings and Facilities• Raw materials received will beplaced in quarantine until tested• Rejected material will beseparated• There will be adequate lighting• There will be adequateenvironmental controls• There will be air breaks on drains
  9. 9. Buildings and Facilities• Sewage and trash willbe stored and disposedof in a safe andsanitary manner• Adequate washing andtoilet facilities will beavailable– hot and cold water– soap– single service towels
  10. 10. Buildings and Facilities• Building will bemaintained in a cleanand sanitary manner• There will be cleaningschedules withapproved cleaningagents– SOPs on cleaning• Buildings in a goodstate of repair
  11. 11. Buildings and Facilities• Buildings maintainedpest and rodent free• Written proceduresand approvedrodentcides,insecticides andfungicides– will not affect product
  12. 12. Equipment• Will be maintained in agood state of repair– written schedule ofmaintenance• will be cleaned– written schedule ofcleaning– clean after each batch• approved cleaning agents– will not affect product• ID number on equipment
  13. 13. Control of Raw Materials• Received in Quarantine– not used until released• Written procedures on receipt,handling and sampling• Stored off the floor• Each container marked with lotnumber, name and status(released, quarantined, rejected)
  14. 14. Control of Raw Materials• Sampling– shall be representative– maintain cleanliness– in approved area– prevent cross contamination– containers marked showingsamples taken
  15. 15. Production and Process Control• There will be written procedures• Document activities– batch record– log books• Control contamination• Cleanliness– tanks, paddles, piping, probes, etc.• Keep organized
  16. 16. Production and Process Control• Reconciliation to bedone• Make sure areas arecleared of other lotinformation(packaging, labeling,etc.) prior to workingwith another lot• Double checks
  17. 17. Warehouse• It shall be clean• Sections clearly identified(quarantine, released,rejected)• quarantine - yellow• released - green• rejected - red• First In - First Out• Track inventory and sold lots(quantities to where)
  18. 18. Laboratory• Will have specifications, standards,sampling plans, test procedures• Shall have a calibration andmaintenance program– written with a time period forperformance• Document all testing– use logbooks
  19. 19. Laboratory• Tell supervisor if something goeswrong– don’t continue with testing if doneimproperly– check results prior to discarding sample• have second person check• check acceptance values• Stability testing will be done• Reserve samples will be kept for finalproducts over the period of theexpiration date
  20. 20. Documentation• Records will be maintained• batch records• testing• investigations• training• maintenance• cleaning• almost everything• If it was not documented, then it didnot happen!• Written in ink
  21. 21. Documentation• Cross out with single line; initialand date• No white-out• Don’t use scrap paper• Change control on all documents• if changes are made, they have to bereviewed• Sign only what you performed orverified
  22. 22. Documentation• Write down correct date– do not write down previous date (backdating)– If you forgot to sign something on aprevious date, correct the problem bywriting:• “Performed on May 10, 2012; written onMay 12, 2012”
  23. 23. Questions?• Contact us at:–– 513-860-3512–– Free consultation over the phoneCopyrighted 2013 by Compliance Insight, Inc. 513-860-3512