CGMP Basics

A Basic Overview of the FDA’s Code of Federal Regulations

Parts 210 & 211

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Basics of CGMPS
• 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

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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
• 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
• Wear clean clothing and practice good sanitation
• Wear protective apparel to prevent contamination
• If you are sick or have open lesions that would impact the drug,
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 of
equipment and material
• Operations will be performed in specific areas
• 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

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Buildings and Facilities (continued)
• 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 and single service towels
• 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
• Buildings maintained pest and rodent free
• Written procedures and 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 lot number, name and status (released,
quarantined, rejected)
• Sampling
• shall be representative
• maintain cleanliness
• in approved area
• prevent cross contamination
• containers marked showing samples taken

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Control of Raw Materials (continued)
• At least one ID test, specific ID if they exist
• Raw materials shall be tested for conformity with all appropriate
written specifications.
• Raw materials that meets the specifications may be approved and
released for use.
• Raw materials that do not meet such specifications shall be rejected.

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 Production and Process Control
• There will be written procedures
• Documentation of activities, such as batch record(s) and
log book(s)

• Control and prevention of contamination

• Maintain cleanliness
• Keep organized
• Reconciliation to be done
• Make sure areas are cleared of other lot
information (packaging, labeling, etc.) prior to
working with another lot
• Double checks
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Packaging and Label Control
• Strict control shall be exercised over labeling issued for use in drug
product labeling operations.
• Procedures shall be used to reconcile the quantities of labeling issued,
used, and returned
• Examination during finishing operations to provide assurance that
containers and packages used in the lot have the correct label.
• Shall bear an expiration date determined by appropriate stability
testing
• New drug products for investigational use are exempt from this requirement

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Warehouse
• It shall be clean
• Sections clearly identified (quarantine, released, rejected)
• Materials shall be used 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 and maintenance program
• written with a time period for performance
• Document all testing
• use logbooks
• Tell supervisor if something goes wrong
• don’t continue with testing if done improperly
• check results prior to discarding sample

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Laboratory (continued)
• Stability testing will be done
• Reserve samples will be kept for final products for 1 year after
the expiration date

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Records and Reports
• Records will be maintained
• batch records, testing, investigations, training, maintenance, cleaning, distribution, complaints,
almost everything

• If it was not documented, then it did not happen!

• Written in indelible ink

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Records and Reports (continued)
• Cross out with single line; initial and date
• No white-out
• Don’t use scrap paper
• Change control on all documents
• Sign only what you performed or verified
• Write down correct date
• do not write down previous date (backdating)
• 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” with Initials

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 Returned and Salvaged Drug Product
• Returned drug products shall be identified as such and held
• Returned drug product shall be destroyed unless
examination, testing, or other investigations prove the drug
product meets appropriate standards of safety, identity,
strength, quality, or purity.
• A drug product may be reprocessed provided the
subsequent drug product meets appropriate standards,
specifications, and characteristics.
• Drug products that have been subjected to improper
storage conditions including extremes in temperature,
humidity, smoke, fumes, pressure, age, or radiation due to
natural disasters, fires, accidents, or equipment failures
shall not be salvaged and returned to the marketplace

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