The document discusses current good manufacturing practices (cGMPs) for biotechnology products. It explains that biotech products are produced from living cells and require strict production, storage, and manufacturing standards to remain effective and safe. The Food and Drug Administration approves biotech products and monitors manufacturers to ensure compliance with cGMPs. cGMPs establish industry-wide quality standards to protect consumers and help ensure consistent product quality. They address personnel, facilities, equipment, production processes, holding and distribution, and recordkeeping.

1. Current Good Manufacturing
Practices (cGMP’s)

2. Biotechnology
• using living cells and materials
produced by cells to create
pharmaceutical, diagnostic,
agricultural, environmental, and other
products to benefit society.

3. How Do Biotech Products
Differ from Chemical Drugs?
• Produced from living cells
• Large, complex molecules
• Extremely sensitive to their
environment
– Production
– Storage
– Manufacturing changes

4. What Does FDA Do?
• Approve products
– Safety
– Effectiveness
– Risk/Benefit determination
• Monitor drug performance
• Monitor investigational studies
• Inspect manufacturers
• Inform physicians and consumers

5. Biotechnology Companies
make products

6. CEO – Chief Executive Officer
COO – Chief Operations Officer
CIO – Chief Information Offices
Vice President of Research and Development
Vice President of Medical Affairs
VP Sales and Marketing
Organizational Structure

7. Operations

8. Operations responsibilities
This is where cGMP
comes into play

9. So What is cGMPs?

10. What are cGMP’s Designed To Do?
• Protect consumers from adulterated
product
• Protect consumers from products that do
not contain what is claimed on the label
• Provide consistent industry-wide
requirements
• Ensure quality of product not safety or
efficacy of dietary ingredients

11. Why have cGMP’s?
• Congress saw need by authorizing
• Food, Drug, and Cosmetic Act gives
authority for cGMP’s
• Product recalls and independent lab
testing demonstrate need for cGMP’s
• Industry and consumers support cGMP’s

12. What caused the need for
cGMP’s?
• Product recalls and independent
laboratory testing demonstrate need for
CGMP’s:
• Poor sanitation--bacterial contamination
• Ingredient often either Superpotent or
Subpotent
• Contaminated with prescription drugs

13. How are cGMPs developed
Considerations and Process:
• How products are manufactured (e.g.
tablets, capsules, powders, liquids)
• Unique properties of dietary ingredients
and dietary supplements (e.g. vitamins,
minerals, botanicals)
• Desire for clear, enforceable regulation
• Considered the estimated costs and
benefits

14. General Provisions
• cGMP should apply to activities associated with
– manufacturing
– packaging
– holding
– distributing
• Manufacturer would need to comply with
requirements applicable to operations performed

15. Components of a cGMP
• Personnel
– qualified employees
– employees must have training and experience
to perform assigned duties
– disease control, and hygienic practices
– assign qualified supervisors to oversee
implementation of cGMP’s

16. Components of a cGMP
• Physical plant internal environment
– design and construction
• ceilings, floors, and walls that are easily cleaned
and maintained
• separate areas or systems for specific operations to
avoid mixups
• screening to keep out pests
– maintenance and sanitation
– water meets EPA drinking water requirements
– plumbing, bathroom, lighting, ventilation, trash
requirements to prevent contamination

17. Components of a cGMP
• Equipment and utensils
–design or select equipment that will
meet pre-established specifications
–maintain, clean, and sanitize
–calibrate, inspect, or check to ensure
proper performance
–ensure that equipment functions as
intended

18. Components of a cGMP
• Production and process controls
– quality control unit
– master manufacturing and batch
production records
– specifications for incoming, in-process, and
final product and
– testing final product or incoming and in-
process materials

19. Considerations of a cGMP
• Holding and Distributing
– to ensure that identity, purity, quality,
strength, and composition are not
adversely affected
• hold and distribute under
– appropriate conditions of temperature,
humidity, and light
– conditions that do not lead to mixup,
contamination, or deterioration

20. Components of a cGMP
• Records and Recordkeeping--
performance records for
– calibration, master manufacturing and
batch production, and consumer
complaints
– keep for 3 years beyond date of
manufacture of batch and
– FDA access to records when requested

21. Production and Process Controls
• System of production and process controls
• Quality control unit
• Manufacturing operations
• Holding and distributing
• Recordkeeping

22. Production and Process Controls
• System of production and process controls
– specifications
– testing
– monitoring, material review, disposition
decision
– master manufacturing record
– batch production record

23. Production and Process Controls
• Quality control unit: One or more persons to
– approve or reject procedures, specifications,
controls, tests, and deviations or modifications
– approve or reject materials received and
product manufactured, packaged, and labeled
– review and approve master manufacturing and
batch production records

24. Production and Process Controls
Master manufacturing record (cont.)
• Prepare and follow
• Include list of components
• Specifications where control is necessary to
prevent adulteration
• Weight or measure for each component
• Instructions for adding, mixing, sampling, testing
• Expected yields
• Specifications for packaging and label to use
• Keep master manufacturing record

25. Production and Process Controls
Batch production record
• Accurately follows master manufacturing
record
• Includes quality control unit review and
approval of
– batch production record
– cross reference of receiving and batch
production records
– any material review and disposition decision
– reprocessing
– release for distribution
• Keep for 3 years beyond date of batch
production

26. Batch Records
• FDA Requirement
• cGMP requirement
• QSR requirement
• ISO requirement
• Failing to do so can get you into a heap of
trouble!
• Used to ensure consistent product

27. Batch Record: Record Keeping
• What are some record keeping
requirements?
– Black ink
– No white out
– Single line, date, initial
– No blanks, N/A any lines which do not apply
– Legible

28. Review and Storage of Batch
Record
• Mfg sign off on Mfg documents
• QC signs off on QC documents and Mfg
documents
• Quality Assurance signs off on the batch
record and their signature indicates they
have reviewed all documents in the record
including Mfg., QC, and any other
document

29. Production and Process Controls
• Manufacturing operations
–design or select to ensure specifications
achieved
–conduct in accordance with sanitation
principles
–take precautions to prevent
contamination

30. Production and Process Controls
• Precautions would include
– protecting against growth of microorganisms and
potential for contamination
– washing or cleaning components that contain soil
or other contaminants
– preventing the growth of microorganisms and
decomposition
– preventing against inclusion of foreign material
– identifying all processing lines and major
equipment used during manufacturing to indicate
their contents, batch/lot number, and when
necessary phase of manufacturing

31. Laboratory Operations
• Establish and follow laboratory controls
• Use adequate facilities in-house or from outside
sources to perform testing and examinations
• Keep laboratory test and examination records