FDA Basic Requirements

1. Basic cGMPs
A Basic Overview of the US FDA’s
Regulations for Regulatory Compliance

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. 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. 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. 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. 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. Buildings and Facilities
• Building will be
adequately sized for
proper storage of
equipment and
material
• Operations will be
performed in specific
areas

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. 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. 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. Buildings and Facilities
• Buildings maintained
pest and rodent free
• Written procedures
and approved
rodentcides,
insecticides and
fungicides
– will not affect product

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. 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. Control of Raw Materials
• Sampling
– shall be representative
– maintain cleanliness
– in approved area
– prevent cross contamination
– containers marked showing
samples taken

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. 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. 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. 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. 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. 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. 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. 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. Questions?
• Contact us at:
– 620-504-2069 (mobile 24x7)
– dennywalthers@gmail.com
– Telecommuting, remote work only