cGMP vs GMP | The difference You need to Know
To be precise there is not much of difference between GMP
and cGMP, GMP (God manufacturing Practices) stresses on the use of QMS and Hygienic
Practices while manufacturing of product and with an extra “C” (Current) cGMP stresses
to use updated and current guidelines with GMP.
To understand where the regulations come from, who has
enforcement authority, and why you need to comply
To understand the “Fundamentals”, “Benefits” and “Key Parts”
of cGMPs
What are
cGMPs?
Current Good Manufacturing Practices
Come from the Food Drug and Cosmetic Act
Rules set up by the FDA that drug manufacturers need to
follow in order to ensure that a safe and effective product is manufactured
Why GMP?
Provides a high level assurance that medicines are
manufactured in a way that ensures their safety, efficacy and quality
GMP applies to both Active Pharmaceutical Ingredients (APIs)
and Finished Pharmaceutical Products (FPPs)
Fundamentals
of cGMPs?
Quality Control, safety, and effectiveness must be designed
and built into the product
Quality cannot be inspected or tested into a finished
product
Each step of manufacturing must be controlled to maximize
the chances that the Finished Good will be acceptable
What are the Benefits of cGMPs?
They outline a Quality System that reduces or prevents
errors
Ensures products are safe for use in humans
Prevent/control contamination and cross-contamination
Minimizes variations in potency of the drug
Ensures reproducible physiological activity
Prevent side effects and toxicity due to variations in drug
content and potency
Prevents mislabelling and adulteration
Good Manufacturing Practices
Quality assurance
Sanitation and hygiene
Qualification and validation
Product recalls
Contract production and analysis
General
The
contract giver
The
contract accepter
The
contract
Self-inspection and quality audits
Items
for self-inspection
Self-inspection
team
Frequency
of self-inspection
Self-inspection
report
Follow-up
action
Quality
audit
Suppliers’
audits and approval
Training
Building and Facilities
General
Ancillary
areas
Storage
areas
Weighing
areas
Production
areas
Quality
control area
Materials
Starting
materials
Packaging
materials
Intermediate
and bulk products
Finished
products
Rejected,
recovered, reprocessed and reworked materials
Recalled
products
Returned
goods
Reagents
and culture media
Reference
standards
Waste
materials
Miscellaneous
Equipment
Documentation or Records
Documents required:
Labels
Testing procedures
Specifications for starting and packaging materials, for
intermediate and bulk products and for finished products
Master formulae and Batch Processing Records
Packaging instructions and Batch Packaging Records
Standard Operating procedures (SOP's) and records
Logbook
Key Parts of cGMP’s
Subpart A: Organization and
Personnel
Subpart B: Buildings and
Facilities
Subpart C: Equipment
Subpart D: Control of Components
and Drug Product Containers and Closures
Subpart E: Production and Process
Controls
Subpart F: Packaging & Labelling
Control
Subpart G: Holding &
Distribution
Subpart H: Laboratory Controls
Subpart I: Records &
Reports
Subpart J: Returned & Salvaged
Drug Product
CGMP REGULATION
Cover street clothes that contain contaminants, organisms
you collect on your way to the plant. Cover your exposed skin which sheds particles
with germs. Cover your hair which have dust & germs. Prevent hair from
falling into the product. Cover the nose and mouth which are natural reservoir
of germs. Trap particles or droplets from the nose and mouth Street shoes
contain germs from the soil and dirt we stepped on, so it must not be worn
inside the plant, plant shoes must be used instead. Cover finger nails and
hands which have germs
Buildings and Facilities
Buildings must be designed with adequate size and space for
operations (helps to eliminate mix-ups)
Facilities must be validated
There must be a good flow pattern for personnel, materials,
products and waste materials (flow from clean to dirty)
The facility must be easy to clean and sanitize (surfaces,
equipment, exposed cords, floors, ceilings…)
Environmental controls must be in place (clean rooms)
Utilities must be validated (water systems, electrical, etc.)
Must have engineering documents describing the layout of the
clean rooms – controlled documents
Changes to the layout of the room after it has been
validated must go through change control procedures and may require
revalidation of the room
Any changes that potentially impact the ventilation in the
room must be assessed for impact on the microbial levels in the room
Microorganisms, particulates, and hazardous materials must
be controlled
Equipment should be selected based on the intended use and clean
ability if it is to be in a clean room
Equipment must be placed in an appropriate location
(temperature, humidity, etc.)
Equipment must be properly qualified (Design, Installation,
Operation, Performance)
Packaging and Labelling Control
Label is a display of a written, printed or graphic matter
upon the immediate container of any article
Labelling is the label and any other packaging material or
container that is printed (ex. IFU, advertising materials)
Procedures must exist that document receiving, identity,
storage, handling, sampling, and testing of labels and ensure that integrity is
maintained throughout production and use of product
Labelling must be separated physically in storage to
avoid mix-ups
Wording of labels cannot be changed unless the FDA is
notified
Labelling must be inspected prior to issuing to
production
All labels must be reconciled (accounted for) if not 100%
inspected.
Label control begins with the design
Records and Reports
Quality Records are the proof that the procedures were
followed and they show traceability of product.
Examples:
Lot History Records
Laboratory Notebooks
Protocols
Reports
Logbooks
Distribution Records
Complaint Files
Summary and conclusions:
GMP compliance is not an option
Quality should be built into the product
GMP's are very similar and are really Good Common Sense
Good Practices cover all aspects of manufacturing activities
prior to supply
The role and involvement of senior management is crucial