Current Good Manufacturing Practices (cGMP).ppt

cGMP refers to current manufacturing practices enforced by US FDA.
cGMP assures proper design, monitoring and control of manufacturing processes and facilities in the industry.
It also includes establishing strong quality management systems, obtaining the right quality of raw materials, establishing operating procedures, detecting and investigating product quality and maintaining reliable testing laboratories.

1. Amity Institute of Pharmacy
CURRENT GOOD
MANUFACTURING
PRACTICE (cGMP)
By: Srishti Gupta
M. Pharm (Pharmaceutics)
Submitted to:
Dr. Kalpana Nagpal

2. Amity Institute of PharmacyContent
•Introduction
•Objectives
•Services
Lighting
Ventilation, air filtration, air heating and cooling
Plumbing
Sewage and refuse
Washing and toilet facilities
Sanitation
•Equipments
Design & construction
Installation & location
Cleaning & maintenance
•Material management
Introduction
Functions
•Production Management
Introduction
Functions

3. Amity Institute of PharmacyINTRODUCTION
•cGMP refers to current manufacturing practices enforced
by US FDA.
•cGMP assures proper design, monitoring and control of
manufacturing processes and facilities in the industry.
•It also includes establishing strong quality management
systems, obtaining the right quality of raw materials,
establishing operating procedures, detecting and
investigating product quality and maintaining reliable
testing laboratories.
•This type of control method at a pharmaceutical company,
if put into practice helps to prevent contamination, mix-ups,
deviations, failures and errors.
•Thus assures that drug product meet the current
manufacturing practice regulations.

4. Amity Institute of PharmacyOBJECTIVES
•Conducting planned and periodic audits.
•Clearly defining and following the SOPs.
•It assures that the quality is built into the
design and manufacturing process at
every step.
•It also assures the identity, strength,
quality and purity of drug product.
•Ensures that the consumer receives
products of specified quality.

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6. Amity Institute of PharmacySERVICES
•Services that are to be provided are:
1.Lighting
2.Ventilation, air filtration, air heating and
cooling
3.Plumbing
4.Sewage and refuse
5.Washing and toilet facilities
6.Sanitation

7. Amity Institute of Pharmacy1. Lighting
•Adequate lighting shall be provided
in all areas to facilitate cleaning,
maintenance and proper operations.

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2. Ventilation, air filtration, air heating
and cooling
•Adequate ventilation shall be provided.
•Equipment for adequate control over air
pressure, micro-organisms, dust, humidity and
temperature should be provided appropriate for
the manufacture, processing, packing or holding
of a drug product.
•Air filtration systems including prefilters and
particulate matter air filters, shall be used
appropriate on air supplies to production areas.

9. Amity Institute of Pharmacy3. Plumbing
•Potable water shall be supplied under
continuous positive pressure in a
plumbing system free of defects that
could contribute contamination to any
drug product.
•Potable water shall meet the standards
as prescribed.

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4. Sewage and Refuse
•Sewage, trash and other refuse from the
building and premises shall be disposed
of in a safe and sanitary manner.
•Drains shall be of adequate size and
were connected directly to a sewer, shall
be provided with an air break or other
mechanical device to prevent back-
siphonage.

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5. Washing and Toilet
•Adequate washing facilities shall be
provided, including hot and cold water,
soap or detergent, air driers or single-
service towels and clean toilet facilities
shall be easily accessible to working
areas.

12. Amity Institute of Pharmacy6. Sanitation
•Any building used in the manufacture, processing,
packaging or holding of a drug product shall be
maintained in clean and sanitary conditions.
•Any such building should be free of infestation by
rodents, birds, insects and other vermin (other than
laboratory animals).
•Trash and organic matter should be held and disposed of
in a timely and sanitary manner.
•There shall be written procedures assigning responsibility
for sanitation and describing in sufficient detail.
•The cleaning schedules, methods, equipment and
material to be used in cleaning building and facilities,
such written procedures should be followed.

13. EQUIPMENTS

14. Amity Institute of PharmacyEQUIPMENTS
•Equipment should be selected based on the intended use
and cleanability.
•Must be placed in an appropriate location.
•Must be properly qualified (design, installation, operational
and performance).
•Constructed so that surfaces are not reactive.
•Automatic, mechanical and electronic equipments should be
calibrated and inspected as per written program to assure
proper performance.
•Computer input/output checked for accuracy.

15. Amity Institute of PharmacyMAINTENANCE
•Weighing, measuring, testing and recording
equipment should be serviced and calibrated regularly.
•All records should be maintained properly.
•Written procedures should include:
Responsibility for equipment cleaning & maintenance.
Cleaning & sanitizing schedules.
Detailed description of cleaning.
Removal of previous batch identification.
Protection of clean equipment.
Inspection of equipment prior to use.

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DESIGN AND CONSTRUCTION
•The equipment surfaces coming into contact with
any in-process material should not react with or
absorb the materials being processed.
•Equipment should not adversely affect the product
through leaking valves, lubricant drips and through
inappropriate modifications or adaptations.
•Equipment should be easily cleaned.
•Equipment used for flammable substances should
be explosion proof.

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INSTALLATION & LOCATION
•Equipment should be located to avoid
congestion and should be properly identified to
assure that products do not become admixed
or confused with one another.
•Water, steam & pressure or vacuum lines,
where applicable should be installed so as to
be easily accessible during all phases of
operation.

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CLEANING & MAINTENANCE
•Equipments & utensils shall be cleaned,
maintained and sanitized at appropriate
intervals to prevent malfunctions or
contamination that would alter the safety,
identity, strength, quality or purity of the drug
product.
•Written procedures shall be established and
followed for cleaning and maintenance of
equipments.

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20. Amity Institute of PharmacyIntroduction
•It is an organizational concept which has the authority
and responsibility of all activities, principally concerned
with the flow of materials in the organization.
•It works continuously with production, marketing, sales
and quality control.
•It has the responsibility of determining the amount of
inventory and its accountability.
•It is concerned with planning, directing & controlling
the kind, amount, location, movement of the various
flows of materials used in and produced by a business
enterprise.

21. Amity Institute of PharmacyFunctions
•Material planning & programming.
•Simplification, standardization and value analysis.
•Purchasing of materials in desired quantities
without delays.
•Receiving of incoming materials.
•Storage, preservation & administration of
materials.
•Production planning & scheduling.
•Transportation & material handling.
•Disposing of rejects materials.

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PRODUCTION
MANAGEMENT

24. Amity Institute of PharmacyIntroduction
•It is defined as planning, implementation
and control of industrial production
process to ensure smooth and efficient
operation.
•Simply, production management is a
process of planning, organizing,
directing and controlling the activities of
the production function.

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