cGMP Training

1. Puzzled by Your Role in cGMP?
2013 Annual GMP Training
Kevin Aquino, Nancy Cary, & Kelly Danyow

2. Purpose
• Provide a general review of current good
manufacturing practices (cGMP).
•Discuss the importance of following cGMPs.
•Provide specific information related to cGMP for each
department at BBD.
•Review requirements for records.
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3. cGMP Review
So, what are cGMPs?
•cGMP refers to current Good Manufacturing Practice regulations enforced
by the FDA.
•cGMPs provide for systems to assure proper design, monitoring, and
control of manufacturing processes and facilities- establish the foundation
for drug quality
• adherence to cGMP regulations assures the SPPI of products by requiring
manufacturers to control operations
•Includes establishing quality management systems, establishing robust
procedures, detecting and investigating product quality deviations, and
maintaining reliable testing laboratories
•cGMP is sameness and consistency across processes, to ensure the
mitigation of variability that can lead to lack of consistency in the quality of
the product
•“current” in cGMP requires companies to use up-to-date technologies and
systems
•cGMPs are minimum requirements- may exceed but must meet
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4. cGMP Review
Why are cGMPs important?
•A consumer cannot easily detect that a drug product is safe or will work
•Testing alone is not enough to ensure adequate quality
•It is important that drugs are manufactured following cGMP regulations to
ensure quality is built into the product at every step
•Blood is a drug! The Food, Drug, and Cosmetic Act defines drugs in part
as “articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease" and "articles (other than food) intended to affect the
structure or any function of the body of man or other animals”
•If manufacturers do not follow cGMP regulations, the drugs it makes are
considered “adulterated” (rendered poorer in quality).
•cGMP violations can lead to seizure or injunction cases even if the drugs
produced are not defective. This can involve destruction of “adulterated”
drugs in a seizure case or forced hiring of outside experts, writing new
procedures, or extensive training of staff in the case of an injunction. The
FDA can also bring criminal cases because of cGMP violations.
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5. cGMP at BBD
Each Department at
BBD plays an
important part in
maintaining cGMPs
throughout our
organization.
• 21 CFR Parts 210, 211 and
606 contain current Good
Manufacturing Practice for
Drugs/Biologics.
•Addressed in Subparts
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6. cGMP at BBD
HR
Organization and Personnel
• Each person involved in the collection,
manufacture, testing, storage and distribution of
blood must have the education, training, and
experience (or combination) to perform
assigned functions and provide assurance that
SPPI of product is maintained
•Personnel must be adequate in number
•Supervisors must have adequate education,
training, experience (or combination) to perform
assigned functions and provide assurance that
SPPI of product is maintained
• Personnel responsibilities- good hygiene and sanitation, appropriate PPE,
free of illness that may adversely affect products
•Consultants must have adequate education, training, experience (or
combination)
•Appropriate records must be maintained (Records and Reports)
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7. cGMP at BBD
Buildings and Facilities
•Buildings must be maintained in a clean and orderly
manner and be of adequate size, construction, and
location
•Operations performed in defined areas to prevent mix-ups
•Adequate lighting, plumbing, ventilation, sanitation
Facilities
& Purchasing
Control of Components and Drug Product Containers
and Closures
•Procedures for receipt, inspection, handling, testing, and approval or rejection of
drug product components and containers
•Handled and stored to prevent contamination
• Distinctive lots and disposition (quarantined, accepted, etc.)
•Rotated so that oldest is used first (FIFO)
Records and Reports
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8. cGMP at BBD
Holding and Distribution
•Must have warehousing procedures, including quarantined products
•Products must be stored to ensure SPPI
•Must have distribution procedures which include inventory rotation
•System to easily determine distribution of products in case of recall
Returned and Salvaged Products
•Returned products must be identified and held until determined
SPPI maintained
•If not, products are destroyed
•Maintain records of returns (Records and Reports)
Distribution
Packaging and Label Control
• Examination of labeling and packing material (rejected if
deemed unsuitable)
•Strict labeling control to prevent mix-ups
•Visual inspection of product and labels
•Expiration dating to ensure product meets SPPI
Production and Process Control
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9. cGMP at BBD
Equipment
•Appropriate in design, size, and location
•Cleaned/maintained at appropriate intervals
•Automated/mechanical/electronic equipment routinely calibrated
Production and Process Controls
•Yield shall be calculated
•All equipment must be identified
•Sampling of each batch must be performed (QC)
•Production time limits
•Written procedures for component preparation methods
•Storage temperatures and methods for controlling temp
Lab
(Component &
Processing)
Laboratory Controls
•Determine strength prior to release
•Test to ensure free from microorganisms
•Sampling plans
•Identification/handling of test samples
Packaging and Label Control
Control of Components and Drug Product Containers and Closures
Records and Reports
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10. cGMP at BBD
Donor Services
Equipment
Production and Process Controls
•Written SOPS shall be maintained and
followed, including:
•Donor suitability criteria
•Methods to prepare phlebotomy site to
ensure a sterile product
•Method to relate product to donor
•Blood collection procedure
•Procedures for automated collections
(plateletpheresis)
•Donor deferral
•QC for supplies used in collection process
Records and Reports
•Donor records- medical interview and phlebotomy, deferrals, therapeutic
requests for phlebotomy, reactions, quarantine records…
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11. cGMP at BBD
Production and Process Controls
•Deviations from procedure shall be
recorded and justified
•Procedures for investigating adverse
donor and recipient reactions
•Consignee notification of unsuitable blood
products
•Identify previous donations of units that
test positive for infectious diseases (look
back)
QCT
Organization and Personnel
•Must have a quality control unit with responsibility to approve or rejects
components, containers, products, and production records
•Made up of members from multiple departments
Reports and Records
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12. cGMP at BBD
Equipment
Automatic, mechanical and electrical equipment
•A back up file of data entered into the computer or related system shall be
maintained
IT
Records
•A donor number shall be assigned to each accepted
donor, which relates the unit of blood collected to that
donor, to his medical record, to any component or blood
product from that donor’s unit of blood, and to all records
describing the history and ultimate disposition of these
products
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13. cGMP at BBD
Production and Process Controls
•SOP’s shall include:
*Criteria used to determine donor suitability,
including acceptable medical history criteria
*Procedures for investigating adverse donor
and recipient reactions
*Procedures for donor deferrals
Scheduling &
Membership
Records and Reports
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14. cGMP at BBD
Facilities
•First step to assuring cGMP requirement
606.40 is met
•When an interest is expressed in hosting a
corporate on-site blood drive, Marketing
provides a checklist to ensure an adequate
space can be provided
MCR
Organization and Personnel
•Responsible for providing and documenting
proper training to volunteers
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15. cGMP at BBD
Finance
Supports departments in meeting cGMPs
throughout the organization by providing
resources:
•Buildings and Facilities
•Equipment
•Organization and Personnel
Executive
Supports the organization in ensuring
adherence to cGMPs
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16. cGMP at BBD
HR
A record is a document stating results achieved or
providing evidence of activities performed.
• Each dept at BBD generates records.
“If it is not documented, it did not happen.”
•Records prove we are compliant to GMP and are
operating in a “State of control”.
Finance
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17. Records
“ Records shall be maintained concurrently with the performance of each step in the
collection, processing, compatibility testing, storage and distribution of each unit of
blood and blood components so that all steps can be clearly traced. All records
shall be legible and indelible, and shall identify the person performing the
work, include dates of the various entries, show test results as well as
interpretation of the results….. And be detailed as necessary to provide a
complete history of the work performed”.
Records include but are not limited to:
•Donor records
•Processing records- results and interpretation of all tests, component
preparation, labeling…
•Storage and distribution records- visual inspection records, disposition
records, temperature records…
•Compatibility testing records- antibody screening…
•Quality control records- calibration, performance checks of
equipment, proficiency test results…
• Transfusion reaction reports and complaints
•General records- biological product deviations, maintenance records, supply
and reagent records, rejected supply records…
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18. Things to Remember…
•If documentation does not occur at the same time a step is performed, this leads to
omissions on our records.
To omit = to fail to do
•We can’t assume that undocumented work has been done!
•Must also identify the person performing the work and the date that the work is
performed.
•provides traceability
•If documentation is not required, the space should be filled in with N/A or as
indicated in form key/legend (if applicable)
• Legible is defined as understandable- clear to any potential reviewer.
•Error corrections must be made appropriately- otherwise, we lose traceability.
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19. Things to Remember…
•When you overwrite or use white-out material, you obliterate original data,
which is unacceptable. Examiner needs to see original data to determine why it
was changed/modified.
When in doubt- cross it out!
•Proper error correction= single line through/ initial and date
•indelible is defined as impossible to remove or permanent.
•We cannot use felt tip pens which may wash away, as well as pencil
which is erasable- these are not indelible.
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20. Summary
.
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21. Blood Bank of Delmarva
100 Hygeia Drive
Newark, DE 19713
Telephone: (302) 737-8405
Toll free: (800) 548-4009
Fax: (302) 737-8233
www.delmarvablood.org
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