1. A Basic Overview of the US FDA’s Regulations for Regulatory Compliance
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 definitions
Part 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 will be cleaned
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 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 Tell 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. Copyrighted 2013 by Compliance Insight, Inc. 513-860-3512
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Copyrighted 2013 by Compliance Insight, Inc