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Current Good Manufacturing

Practices (cGMPs)
using living cells and materials
produced by cells to create
pharmaceutical, diagnostic,
agricultural, environmental, and other
products to benefit society.
How Do Biotech Products
Differ from Chemical Drugs?
Produced from living cells
Large, complex molecules
Extremely sensitive to their
Manufacturing changes
What Does FDA Do?
Approve products
Risk/Benefit determination
Monitor drug performance
Monitor investigational studies
Inspect manufacturers
Inform physicians and consumers
Biotechnology Companies
make products
Organizational Structure
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
Operations responsibilities

This is where cGMP

comes into play
So What is cGMPs?
What are cGMPs Designed To Do?

Protect consumers from adulterated

Protect consumers from products that do
not contain what is claimed on the label
Provide consistent industry-wide
Ensure quality of product not safety or
efficacy of dietary ingredients
Why have cGMPs?
Congress saw need by authorizing
Food, Drug, and Cosmetic Act gives
authority for cGMPs
Product recalls and independent lab
testing demonstrate need for cGMPs
Industry and consumers support cGMPs
What caused the need for
Product recalls and independent
laboratory testing demonstrate need for
Poor sanitation--bacterial contamination
Ingredient often either Superpotent or
Contaminated with prescription drugs
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
General Provisions
cGMP should apply to activities associated with
Manufacturer would need to comply with
requirements applicable to operations performed
Components of a cGMP

qualified employees
employees must have training and experience
to perform assigned duties
disease control, and hygienic practices
assign qualified supervisors to oversee
implementation of cGMPs
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
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
Components of a cGMP
Production and process controls
quality control unit
master manufacturing and batch production
specifications for incoming, in-process, and
final product and
testing final product or incoming and in-
process materials
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
Components of a cGMP

Records and Recordkeeping--

performance records for
calibration, master manufacturing and
batch production, and consumer
keep for 3 years beyond date of
manufacture of batch and
FDA access to records when requested
Production and Process Controls

System of production and process controls

Quality control unit
Manufacturing operations
Holding and distributing
Production and Process Controls

System of production and process controls

monitoring, material review, disposition
master manufacturing record
batch production record
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
Production and Process Controls
Master manufacturing record (cont.)
Prepare and follow
Include list of components
Specifications where control is necessary to
prevent adulteration
We ight or measure for each component
Instructions for adding, mixing, sampling, testing
Expected yields
Specifications for packaging and label to use
Keep master manufacturing record
Production and Process Controls
Batch production record
Accurately follows master manufacturing
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
release for distribution
Keep for 3 years beyond date of batch
Batch Records
FDA Requirement
cGMP requirement
QSR requirement
ISO requirement
Failing to do so can get you into a heap of
Used to ensure consistent product
Batch Record: Record Keeping
What are some record keeping
Black ink
No white out
Single line, date, initial
No blanks, N/A any lines which do not apply
Review and Storage of Batch
Mfg sign off on Mfg documents
QC signs off on QC documents and Mfg
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
Production and Process Controls
Manufacturing operations
design or select to ensure specifications
conduct in accordance with sanitation
take precautions to prevent
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
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
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