cGMP

Introduction

• The Food and Drug Administration (FDA) regulates

the quality of pharmaceuticals very carefully.
• The main regulatory standard for ensuring
pharmaceutical quality is the Current Good
Manufacturing Practice (CGMP) regulations for
human pharmaceuticals.
 What is CGMP?

• cGMP refers to the Current Good Manufacturing

Practice regulations enforced by the FDA.
• cGMP provides for systems that assure
✔ proper design,
✔ monitoring,
✔ and control of manufacturing processes and facilities.
• The regulations make sure that a product is safe for
use, and that it has the ingredients and strength it
claims to have.
 What is CGMP?

• Accordingly, the “c" in cGMP stands for "current,"

requiring companies to use technologies and systems
that are up-to-date in order to comply with the
regulations.

• Systems and equipment that may have been

"top-of-the-line" to prevent;
✔ contamination
✔ mix-ups
✔ and errors
• Adherence to the CGMP regulations assures the

✔ identity
✔ strength
✔ quality
✔ and purity of drug products
 cGMP Covers

• This includes;
i. establishing strong quality management systems
ii. obtaining appropriate quality raw materials
iii. establishing robust operating procedures
iv. detecting and investigating product quality
deviations

v. and maintaining reliable testing laboratories

 cGMP Importance

• This formal system of controls at a pharmaceutical

company, if adequately put into practice, helps to
prevent
✔ instances of contamination
✔ mix-ups
✔ deviations
✔ failures,
✔ and errors
• This assures that drug products meet their quality
standards.
 Implementing cGMPs in
five step

1. Research: Take the time to learn about the latest

cGMP regulations in the country of each manufacturing
facility.
 Implementing cGMPs
in five step
2. Development: Write down what you do, including
various elements and tools such as policies, standard
operating procedures (SOPs), schedules, records, and
logistics.

• Conduct a risk assessment and scale the risk levels for

possible hazards.

• Ensuring the program can reduce and eliminate

significant hazards is crucial at this stage.
 Implementing cGMPs
in five step
3. Implementation: When rolling out cGMPs,
companies should inform employees about policies
and train them on procedures, corrective actions, and
proper recordkeeping.

• Companies need to provide the necessary resources

and tools for employees to carry out their assigned
duties at this stage.
 Implementing cGMPs
in five step

4. Validation: It’s essential to validate the programs and

procedures to confirm they meet the necessary
guidelines and applicable standards.
• Companies need to verify the program is serving its
intended purpose.

• cGMP validation should occur at initial and annual

stages and whenever changes occur.
 Implementing cGMPs
in five step

5. Verification: When verifying cGMPs, companies

must check procedures regularly to confirm they
remain effective.
 cGMPs Requirements

• Documentation and recordkeeping

• Personnel practices
• Sanitation
• Facility and building design
• Equipment and preventive maintenance (PM)

• Receiving, storing, and shipping

• Recalls
 Personnel practices

• Each person engaged in the supervising, manufacture,

processing, packing, or holding of a drug product shall have
education, training, and experience.
• There shall be an adequate number of qualified personnel
• Any person shown at any time (either by medical examination
or supervisory observation) to have an apparent illness or open
lesions shall be excluded from direct contact to components
 Personnel practices

• Personnel engaged in the manufacture, processing,

packing, or holding of a drug product shall wear clean
clothing appropriate for the duties they perform.
• Protective apparel, such as head, face, hand, and arm
coverings, shall be worn as necessary to protect drug
products from contamination.
 Facility and building design

• Any building or buildings used in the manufacture, processing,

packing, or holding of a drug product shall be of suitable size,
construction and location to facilitate cleaning, maintenance,
and proper operations.
• Any such building shall have adequate space for the orderly
placement of equipment and materials to prevent mix ups
between different components.
 Facilities to be provided

• Floors, walls, and ceilings of smooth, hard surfaces that are

easily cleanable
• An air supply filtered through high-efficiency particulate air
filters
• Any building used in the manufacture, processing, packing, or
holding of a drug product shall be maintained in a clean and
sanitary condition
 Facilities to be provided

• A system for monitoring environmental conditions

• A system for cleaning and disinfecting the room and
equipment to produce aseptic conditions

• Adequate lighting

• Adequate ventilation
 Equipment and preventive
maintenance (PM)
• Equipment shall be constructed so that surfaces that
contact components, in-process materials, or drug
products shall not be reactive, additive, or absorptive.
• Equipment and utensils shall be cleaned, maintained,
and, as appropriate for the nature of the drug,
sterilized at appropriate intervals to prevent
malfunctions or contamination
 Production & process control

• There shall be written procedures for production and process

control designed to assure that the drug products have the
identity, strength, quality, and purity they possess or are
represented to possess
• All compounding and storage containers, processing lines, and
major equipment used during the production of a batch of a
drug product shall be properly identified
 Production & process control

• To assure batch uniformity and integrity of drug products,

written procedures shall be established and followed that
describe the in-process controls, and tests, or examinations to
be conducted.
• Written procedures shall be established and followed
prescribing a system for reprocessing batches that do not
conform to standards or specifications.
 Packaging & Labeling control

• There shall be written procedures describing in sufficient detail

the receipt, identification, storage, handling, sampling,
examination, and/or testing of labelling and packaging
materials.
• Records shall be maintained for each shipment received of
each different labelling and packaging material indicating
receipt, examination or testing, and whether accepted or
rejected.
 Packaging & Labeling control

• Any labelling or packaging materials meeting

appropriate written specifications may be approved
and released for use.
• Labels and other labelling materials for each different
drug product, strength, dosage form, or quantity of
contents shall be stored separately with suitable
identification
 Storage & shipment

• Storage of drug products should be under appropriate

conditions of temperature, humidity, and light
• A procedure whereby the oldest approved stock of a
drug product is distributed first.

• A system by which the distribution of each lot of drug

product can be readily determined to facilitate its
recall if necessary
 Laboratory controls

• Laboratory controls shall include the establishment of

scientifically sound and appropriate specifications,
standards, sampling plans, and test procedures
designed to assure that components, drug product
containers, closures, in-process materials, labelling,
and drug products conform to appropriate standards
of identity, strength, quality, and purity
 Laboratory controls

• Any sampling and testing plans shall be described in

written procedures that shall include the method of
sampling and the number of units per batch to be
tested

• The accuracy, sensitivity, specificity, and

reproducibility of test methods employed by the firm
shall be established and documented
 Laboratory controls

• Drug products failing to meet established standards or

specifications and any other relevant quality control
criteria shall be rejected
• Animals used in testing components, in-process
materials, or drug products for compliance with
established specifications shall be maintained and
controlled in a manner that assures their suitability for
their intended use
 Documentation
(Records & Reports)
• A written record of major equipment cleaning,
maintenance (except routine maintenance such as
lubrication and adjustments), and use shall be
included in individual equipment logs that show the
date, time, product, and lot number of each batch
processed
 Documentation
(Records & Reports)

• The identity and quantity of each shipment of each lot

of components, drug product containers, closures, and
labelling; the name of the supplier; the supplier's lot
number etc must be recorded
 Documentation
(Records & Reports)

• Batch production and control records shall be

prepared for each batch of drug product produced
• Laboratory records shall include complete data
derived from all tests necessary to assure compliance
with established specifications and standards
 Documentation
(Records & Reports)
• Distribution records shall contain

✔ the name and strength of the product

✔ description of the dosage form
✔ name and address of the consignee
✔ date and quantity shipped

✔ and lot or control number of the drug product

 Returned drug products

• Drug products that have been subjected to improper

storage conditions including;
i. extremes in temperature
ii. humidity
iii. smoke
iv. fumes
v. pressure
vi. age
vii. or radiation due to natural disasters
viii. fires
ix. accidents, or equipment failures shall not be returned to the
marketplace
 Returned drug products

• Records of returned drug products shall be

maintained and shall include the
i. name and label potency of the drug product
dosage form
ii. lot number (or control number or batch number)
iii. reason for the return
iv. quantity returned
v. date
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manufacturing-practice-cgmp-regulations)