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Basic cGMPs
A Basic Overview of the US FDAs
Regulations for Regulatory
Compliance
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Basic cGMPs
Remember, QUALITY
is the responsibility of
everyone Dont just make the
product or do your job
and leave it up to
Quality Assurance fixthe problems
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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
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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
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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
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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 thedrug, then you will be
excluded from direct contact
with the product
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Buildings and Facilities
Building will be
adequately sized for
proper storage ofequipment and
material
Operations will be
performed in specificareas
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Buildings and Facilities
Raw materials received will be
placed 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
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Buildings and Facilities
Sewage and trash will
be stored and disposed
of in a safe andsanitary manner
Adequate washing and
toilet facilities will be
available hot and cold water
soap
single service towels
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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
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Buildings and Facilities
Buildings maintained
pest and rodent free
Written proceduresand approved
rodentcides,
insecticides and
fungicides will not affect product
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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
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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)
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Control of Raw Materials
Sampling
shall be representative
maintain cleanliness in approved area
prevent cross contamination
containers marked showing
samples taken
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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
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Production and Process Control
Reconciliation to be
done
Make sure areas arecleared of other lot
information
(packaging, labeling,
etc.) prior to workingwith another lot
Double checks
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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)
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Laboratory
Will have specifications, standards,
sampling plans, test procedures
Shall have a calibration andmaintenance program
written with a time period for
performance
Document all testing
use logbooks
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Laboratory
Tell supervisor if something goes
wrong
dont 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 final
products over the period of the
expiration date
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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
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Documentation
Cross out with single line; initial
and date
No white-out Dont use scrap paper
Change control on all documents if changes are made, they have to be
reviewed
Sign only what you performed or
verified
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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
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