Current Good Manufacturing Practices (cGMP).ppt

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

Content
• 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

INTRODUCTION
• 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.

OBJECTIVES
• 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.

SERVICES
• 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

1. Lighting
• Adequate lighting shall be provided
in all areas to facilitate cleaning,
maintenance and proper operations.

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.

3. 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.

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.

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.

6. 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.

EQUIPMENTS
• 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.

MAINTENANCE
• 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.

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.

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.

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.

Introduction
• 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.

Functions
• 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.

PRODUCTION
MANAGEMENT

Introduction
• 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.

Current Good Manufacturing Practices (cGMP).ppt

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