GMP

 Yashwanth A M
 Asst Professor
 Dept of Pharmaceutics
 GMP

• Good Manufacturing Practice is a set of regulations,

codes, and guidelines for the manufacture of drug
substances and drug products, medical devices, in vivo
and in vitro diagnostic products, and foods.
 Good Manufacturing Practices

• A basic principle of GMP is that quality cannot be tested into a

batch of product but must be built into each batch of product
during all stages of the manufacturing process.

• It is designed to minimize the risks involved in any pharmaceutical

production that cannot be eliminated through testing the final product.
 Principles of GMP
• To harmonize the manufacturing procedures globally with a marked standard,
which assures that the product is been manufactured in a good facility and having a
quality product.
• It provide the frame of SISPQ i.e. Safety, Identity, Strength, Potency and Quality to a
drug product.
• GMP is based on the controlled production of drug products, under the federal Food
Drug and Cosmetic act, which states that , “A drug products will be deemed to be
adulterated unless the method used in or facilities or controls used for its
manufacture, processing, packaging, or holding conforms are operates in conformity
with current GMP.”
 C-GMP
• cGMP means Current good manufacturing practices.
• CFR (Code of federal Regulations ), published by Federal government
• In CFR total 50 Chapters present
• Chapter 21: Food & Drug manufacturing.
• The US GMP regulations are divided into two parts: 210 and 211, Title 21.
• Part 210. "Current Good Manufacturing Practices in manufacturing.
Processing, Packing or Holding of Drugs ", basically it provides the
framework far the regulation.
• Part 211., " Current good manufacturing practices for Finished products
• The part 211 is further divided into 11 subparts ,Subpart A to Subpart K
Content of part 211 of US GMP regulation:
• Subpart A : General Provision
• Subpart B: Organization and personnel
• Subpart C : Buildings and Facilities
• Subpart D: Equipment's
• Subpart E : Control of components and Drug product containers and closures
• Subpart F: Production and process controls
• Subpart G: Packaging and labeling Control
• Subpart H :Holding and Distribution
• Subpart I: Laboratory Control
• Subpart J: Records and reports
• Subpart K: Returned and salvaged drug products
 Subpart A: GENERAL REQUIREMENTS

 Avoid risks and possibilities of mix-up at all stages of

manufacturing, labeling, packaging and testing and regular
monitoring of temp & humidity, Particle Count,
DOP(dispersed oil particulate) testing etc.

 Proper drainage system which prevents backflow.

 Avoid open channels and if provided must be able to clean

and disinfect.
 Subpart B: Organization and personnel
✓ Every person involve in the manufacturing process, packaging,
or holding of the drug products must have education,
training and proper experience to perform the activity in a
proper and defined manner.
✓ Every employee should have a GMP training at least once in
a year and also at the time of induction.
✓ Proper strength of qualified persons should be there.
✓ Proper Visit and Guidance of Consultant should be preferred.
Personnel responsibilities
 Should wear clean clothing also should take daily bath and
shave.
 Personnel shall practice good sanitization and health
habits.
 Subpart C- B u i l d i n g a n d f a c i l i t i e s
✓ Design and construction features
✓ Building should be of suitable size, construction to facilitate
cleaning, maintenance proper operation.
✓ Space for all the equipment’s, instruments and also for storage of
raw material, in-process material and finished products.
✓ Movement of component should he controlled to avoid contamination.
✓ Storage of release components, drug products, containers, closures,
and labeling.
✓ Holding of reject material and to be store them in lock and key
✓ Storage of in process material.
✓ Manufacturing and processing operation.
✓ Packaging and labeling.
✓ Quarantine storage before release of drug products.
✓ Storage of drug products after release
 Subpart D: Equipment
✓ Equipment should be appropriate design, adequate size and
suitably located to facilitate operation for its intended use and
for cleaning and maintenance.
✓ Equipment should be constructed with such a material that
does not contaminate the material in touch and also should be
inert in nature, should be corrosion free.
✓ Equipment should be designed in such a way that's its
cleaning should be conducted easily, also proper sanitization
schedule should be there for every equipment and instrument.
✓ For those equipment which are software controlled or
computer controlled there should be a routinely calibration,
inspection or checking program, with respect to the SOP
should be governed.
 Subpart F: Production and process control
✓ Set - Written procedures and procedure
for deviations:
✓ Follow the SOP during all process.
✓ Proper flow of material by FIFO
mechanism.
✓ Dispensing.
✓ Shifting.
✓ Sampling and testing of in-process
material and drug products
✓ Control of microbial contamination.
✓ Reprocessing.
 Subpart G: Packaging and Labeling control
✓ Material examination and usage criteria: Testing,
Issuance, handling, sampling, examination and
approval.
✓ Proper Issuance control.
✓ Execution of proper Batch packaging records
✓ Tamper evident packaging requirement for OTC
human drug products.
✓ Proper Labeling.
✓ Proper container and closure selection.
✓ Drug product inspection.
✓ Expiration dating.
Subpart H: Holdings and Distribution

✓ Testing and release for distribution.

✓ Stability testing
✓ Reserve samples.
✓ Animals used in testing components.
 Subpart I: Laboratory Control
✓ Responsibilities of quality control unit:
✓ The QC unit must be given responsibility
and authority to approve or reject a l l
c o m p o ne n t s - drug products containers,
closures, process material , packaging
material, labeling and drug products.
✓ Adequate laboratory facilities for testing and
approval or rejection of the above listed materials
must be available.
✓ Establishment of scientifically sound and
appropriate specification, standard test
procedures, sampling plans, test procedures
design to assure the material conforms to
appropriate standards.
 Subpart J: Records

✓ Document all GMP activities

✓ Use Good Documentation Practices (GDP)
✓ Records must be readily available

 Documentation must be:

 Permanent (black or blue ink)
 L e g i b l e , c l e a r, concise
 Accurate
 Ti m e l y c o m p l e t e
 Subpart K Returned drug salvaged
 Returned drug products shall he identified as
such and held. If the conditions under which
returned drug products have been held, stored or
shipped before or during the return or if the
condition of the drug product , its container,
carton or labelling as a result of storage or
shipping, casts doubt on the safety, identity,
strength.
 Drug salvaging :Drug have been subjected to
improper storage conditions extreme in
temperature, humidity, smoke, fumes, pressure,
or radiation due to natural disasters, fires shall
not be salvaged and returned to the returned
to the marketplace.
Link for FDA cGMP

 https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-
good-manufacturing-practice-cgmp-regulations
Thank You