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Basic cGMPs
A Basic Overview of the US FDA’s
Regulations for Regulatory Compliance
Basic cGMPs
• Remember, QUALITY
is the responsibility of
everyone
• Don’t just make the
product or do your job
and leave i...
The Regulations
• cGMP stands for “current
Good Manufacturing
Practices”
• Always improving and
changing (that is why they...
The Regulations
• cGMPs are listed in
the CFR (Code of
Federal Regulations)
Part 210 and 211
• Part 210 - definitions
• Pa...
Organization and Personnel
• Shall have a Quality Unit
with responsibility to reject
or approve all material,
procedures a...
Organization and Personnel
• Wear clean clothing
• Wear protective apparel to
prevent contamination
• Practice good sanita...
Buildings and Facilities
• Building will be
adequately sized for
proper storage of
equipment and
material
• Operations wil...
Buildings and Facilities
• Raw materials received will be
placed in quarantine until tested
• Rejected material will be
se...
Buildings and Facilities
• Sewage and trash will
be stored and disposed
of in a safe and
sanitary manner
• Adequate washin...
Buildings and Facilities
• Building will be
maintained in a clean
and sanitary manner
• There will be cleaning
schedules w...
Buildings and Facilities
• Buildings maintained
pest and rodent free
• Written procedures
and approved
rodentcides,
insect...
Equipment
• Will be maintained in a
good state of repair
– written schedule of
maintenance
• will be cleaned
– written sch...
Control of Raw Materials
• Received in Quarantine
– not used until released
• Written procedures on receipt,
handling and ...
Control of Raw Materials
• Sampling
– shall be representative
– maintain cleanliness
– in approved area
– prevent cross co...
Production and Process Control
• There will be written procedures
• Document activities
– batch record
– log books
• Contr...
Production and Process Control
• Reconciliation to be
done
• Make sure areas are
cleared of other lot
information
(packagi...
Warehouse
• It shall be clean
• Sections clearly identified
(quarantine, released,
rejected)
• quarantine - yellow
• relea...
Laboratory
• Will have specifications, standards,
sampling plans, test procedures
• Shall have a calibration and
maintenan...
Laboratory
• Inform supervisor if something goes
wrong
– don’t continue with testing if done
improperly
– check results pr...
Documentation
• Records will be maintained
• batch records
• testing
• investigations
• training
• maintenance
• cleaning
...
Documentation
• Cross out with single line; initial
and date
• No white-out
• Don’t use scrap paper
• Change control on al...
Documentation
• Write down correct date
– do not write down previous date (back
dating)
– If you forgot to sign something ...
Questions?
• Contact us at:
– 620-504-2069 (mobile 24x7)
– dennywalthers@gmail.com
– Telecommuting, remote work only
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Basic cGMPs

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FDA Basic Requirements

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Basic cGMPs

  1. 1. Basic cGMPs A Basic Overview of the US FDA’s Regulations for Regulatory Compliance
  2. 2. Basic cGMPs • Remember, QUALITY is the responsibility of everyone • Don’t just make the product or do your job and leave it up to Quality Assurance fix the problems
  3. 3. The Regulations • cGMP stands for “current Good Manufacturing Practices” • Always improving and changing (that is why they are called “current”) • Regulations are a minimum that must be met
  4. 4. The Regulations • cGMPs are listed in the CFR (Code of Federal Regulations) Part 210 and 211 • Part 210 - definitions • Part 211 - basic instructions • Part 11 - electronic data
  5. 5. Organization and Personnel • Shall have a Quality Unit with responsibility to reject or approve all material, procedures and specifications • Everyone will have sufficient training, knowledge and experience to do their job
  6. 6. Organization and Personnel • Wear clean clothing • Wear protective apparel to prevent contamination • Practice good sanitation • If you are sick or have open lesions that would impact the drug, then you will be excluded from direct contact with the product
  7. 7. Buildings and Facilities • Building will be adequately sized for proper storage of equipment and material • Operations will be performed in specific areas
  8. 8. Buildings and Facilities • Raw materials received will be placed in quarantine until tested • Rejected material will be separated • There will be adequate lighting • There will be adequate environmental controls • There will be air breaks on drains
  9. 9. Buildings and Facilities • Sewage and trash will be stored and disposed of in a safe and sanitary manner • Adequate washing and toilet facilities will be available – hot and cold water – soap – single service towels
  10. 10. Buildings and Facilities • Building will be maintained in a clean and sanitary manner • There will be cleaning schedules with approved cleaning agents – SOPs on cleaning • Buildings in a good state of repair
  11. 11. Buildings and Facilities • Buildings maintained pest and rodent free • Written procedures and approved rodentcides, insecticides and fungicides – will not affect product
  12. 12. Equipment • Will be maintained in a good state of repair – written schedule of maintenance • will be cleaned – written schedule of cleaning – 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 lot number, name, date 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 showing samples 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 be done • Make sure areas are cleared of other lot information (packaging, labeling, etc.) prior to working with 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 and maintenance program – written with a time period for performance • Document all testing – use logbooks
  19. 19. Laboratory • Inform supervisor if something goes wrong – don’t continue with testing if done improperly – check results prior to discarding sample • have second person check • check acceptance values • Stability testing will be done • Reserve samples will be kept for final products over the period of the expiration date
  20. 20. Documentation • Records will be maintained • batch records • testing • investigations • training • maintenance • cleaning • almost everything • If it was not documented, then it did not happen! • Written in ink
  21. 21. Documentation • Cross out with single line; initial and date • No white-out • Don’t use scrap paper • Change control on all documents • if changes are made, they have to be reviewed • Sign only what you performed or verified
  22. 22. Documentation • Write down correct date – do not write down previous date (back dating) – If you forgot to sign something on a previous date, correct the problem by writing: • “Performed on May 10, 2012; written on May 12, 2012”
  23. 23. Questions? • Contact us at: – 620-504-2069 (mobile 24x7) – dennywalthers@gmail.com – Telecommuting, remote work only

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