The document discusses current good manufacturing practices (cGMP) regulations for pharmaceutical manufacturing. It covers several topics: cGMP regulations provide systems for proper design, monitoring, and control of manufacturing to ensure identity, strength, quality and purity of drug products. Facilities must have adequate design and construction to prevent contamination. Equipment must be properly qualified, installed and maintained. Sanitation procedures help prevent contamination and ensure compliance. Overall, cGMP helps assure safety and efficacy of drug products.

1. Modern Pharmaceutics
Dr. Kailas Mali
Professor in Pharmaceutics,
Adarsh College of Pharmacy, Vita
cGMP and Industrial Management

2. 1. Objectives and policies of current good manufacturing practices,
2. Layout of buildings
3. Services
4. Equipments and their maintenance
Contents

3. ● cGMPs provide for systems that assure proper
design, monitoring, and control of
manufacturing processes and facilities.
● Adherence to the cGMP regulations assures the
identity, strength, quality, and purity of drug
products by requiring that manufacturers of
medications adequately control manufacturing
operations.
● This includes establishing strong quality
management systems, obtaining appropriate
quality raw materials, establishing robust
operating procedures, detecting and investigating
product quality deviations, and maintaining
reliable testing laboratories.
Introduction
● cGMP refers to Current Good Manufacturing
Practice (cGMP) regulations enforced by
USFDA.
● Current Good Manufacturing Practices are the
methods to be used in, the facilities or controls to
be used for, the manufacturing processing,
packaging or holding of a drug to assure that
such drug meets the requirements of the act, and
has the identity and strength and meets the
quality and purity characteristics that is
represented to possess.

4. ● The flexibility in these regulations allows
companies to use modern technologies and
innovative approaches to achieve higher quality
through continual improvement.
● 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 10 or 20 years ago may be less
than adequate by today's standards.
Introduction
● 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.
● The cGMP requirements were established to be
flexible in order to allow each manufacturer to
decide individually how to best implement the
necessary controls by using scientifically sound
design, processing methods, and testing
procedures.

5. ● Facilities that are in good condition, equipment
that is properly maintained and calibrated,
employees who are qualified and fully trained,
and processes that are reliable and reproducible,
are a few examples of how cGMP requirements
help to assure the safety and efficacy of drug
products.
Code of Federal Regulations
● Part 210 Current Good
Manufacturing Practice in Manufacturing,
Processing, Packing, or Holding of Drugs;
● Part 211 Current Good
Manufacturing Practice for Finished
Pharmaceuticals
Introduction
Importance of cGMP
● A consumer usually cannot detect that the
product is safe or efficacious.
● Poor quality medicines are not only a health
hazard, but a waste of money.
● Therefore, it is important that a drugs are
manufactured under conditions and practices
required by the cGMP regulations to assure that
the quality is built into the design and
manufacturing process at every step.

6. ● Ensure that the consumer receives products of
specified quality. [The quality of a product
depends on the starting materials, production and
quality control process, building, equipment and
personnel involved.
● cGMP regulations assures the identity, strength,
quality and purity of drug products.
Objectives of cGMP
● Ensures that products are consistently
manufactured and controlled to the specified
quality.
● Concerned will all aspects of production and
quality control.
● In the manufacture of cosmetics products,
overall control and monitoring.

7. ● (c) Operations shall be performed within
specifically defined areas of adequate size. There
shall be separate or defined areas or such other
control systems for the firm's operations as are
necessary to prevent contamination or mixups
during the course of the procedures.
● (d) Operations relating to the manufacture,
processing, and packing of penicillin shall be
performed in facilities separate from those used for
other drug products for human use.
Design and construction features
● (a) 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.
● (b) Any such building shall have adequate space for
the orderly placement of equipment and materials to
prevent mixups between different components, drug
product containers, closures, labeling, in-process
materials, or drug products, and to prevent
contamination. The flow of components, drug
product containers, closures, labeling, in-process
materials, and drug products through the building or
buildings shall be designed to prevent
contamination.
21CFR Part 211

8. Layout of design should aim to
● Minimize the risk of errors
● Permit effective maintenance
● Avoid cross contamination, buildup of dust and
dirt.
● Avoid any adverse effect on the quality of
products.
Type of flow
● Circular flow
● Parallel flow
● Crossover traffic
Layout of buildings
● Plant layout is a coordinated effort to achieve the
final objective to integrate machines, materials
and personnel for economic production.
● Involves location of different departments and
arrangements of machinery in each department.
● It is the organized properly planned
interdepartment and intradepartment
arrangements.
● Proper layout increases productivity and help
proper utilization of man, material, money and
machines.

9. Layout of Buildings ensures
● Prevention of cross contamination.
● Proper air handling system.
● Proper cleaning & sanitary conditions.
● Proper lighting
● Proper plumbing
● Proper washing
Layout of buildings
Importance of Plant Layout
● It is long term commitment.
● It facilitates the production process, minimizes
material handling, time & cost, and allows
flexibility of operations.
● It facilitates easy production flow, makes
economic use of the building, promotes effective
utilization of manpower & provides for
employee’s convenience, safety, comfort at
work, maximum exposure to natural light &
ventilation.
● It affects the flow of material & processes,
labour efficiency, supervision & control, use of
space & expansion facilities.

10. Type of flow/ layout
● Circular flow
● Parallel flow
● Crossover traffic
Layout of buildings
Objectives of Plant Layout
● Proper & efficient utilization of available floor
space.
● Provide enough production capacity.
● Reduce material handling cost.
● Reduce hazards to personnel.
● Utilize labor efficiently.
● Reduce accidents.
● Provide ease of supervision & control.
● Provide employee safety & health,
● Allow ease of maintenance.
● Better interdepartment relationship.

11. Layout of buildings
Circular Flow Parallel Flow

12. Layout of buildings
Crossover Traffic

13. Product or straight line layout
● The arrangement of machines doing various
operations in a line as one department.
● Advantages: Processing of work is quick and
smooth; Cost of handling is reduced using
conveyers; Manufacturing time can be reduced;
Floor space can be properly utilized.
Layout of buildings
Types of plant layout
● Process layout or functional layout
● Product or straight line layout
Process layout or functional layout
● Arrangement of machines of a particular class
doing a particular process as separate
compartment.
● Advantage: More effective supervision and
division of labour can be provided.
● Disadvantage: May not be possible as a number
of unit operations have to be performed.

14. Stores layout
● Should be planned in the objectives of achieving
minimum wastage of space and achieving
maximum ease of operations.
The layout should
● Make optimum utilization of floor space and
height.
● Should be 1.5-3m wide to facilitate traffic.
● Permit effective and orderly segregation of
various categories of materials and allow
rotation of stock (First in first out)
● Have provisions for storage as per specific
conditions.
● Adequately protected from waste, damage and
deterioration.
Layout of buildings
Factors influencing plant layout
● Basic managerial policies and decisions.
● Nature of plat layout
● Type of industry and process
○ Intermittent industries
○ Continuous industries
● Types of methods of production
○ Job production
○ Batch or lot production
○ Continuous or mass production

15. ● Air filtration systems, including prefilters and
particulate matter air filters, shall be used when
appropriate on air supplies to production areas. If
air is recirculated to production areas, measures
shall be taken to control recirculation of dust
from production. In areas where air
contamination occurs during production, there
shall be adequate exhaust systems or other
systems adequate to control contaminants.
● Air-handling systems for the manufacture,
processing, and packing of penicillin shall be
completely separate from those for other drug
products for human use.
Services
Lighting
● Adequate lighting shall be provided in all areas.
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 shall be provided when appropriate
for the manufacture, processing, packing, or
holding of a drug product.

16. ● Drains shall be of adequate size and, where
connected directly to a sewer, shall be provided
with an air break or other mechanical device to
prevent back-siphonage.
Sewage and refuse
● Sewage, trash and other refuse from the building
and premises shall be disposed of in a safe and
sanitary manner.
Washing and toilet facilities
● Adequate washing facilities shall be provided,
including hot and cold water, soap or detergent,
air driers or single service towels, and clean
toilet facilities easily accessible to working
areas.
Services
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 prescribed
● Water not meeting such standards shall not be
permitted in the potable water system.
● Drains shall be of adequate size and, where
connected directly to a sewer, shall be provided
with an air break or other mechanical device to
prevent back-siphonage.

17. ● There shall be written procedures for use of suitable
rodenticides, insecticides, fungicides, fumigating
agents, and cleaning and sanitizing agents. Such
written procedures shall be designed to prevent the
contamination of equipment, components, drug
product containers, closures, packaging, labeling
materials, or drug products and shall be followed.
Rodenticides, insecticides, and fungicides shall not
be used unless registered and used in accordance
with act.
● Sanitation procedures shall apply to work performed
by contractors or temporary employees as well as
work performed by full-time employees during the
ordinary course of operations.
Services
Sanitation
● Any building used in the manufacture, processing,
packing, or holding of a drug product shall be
maintained in a clean and sanitary condition, Any
such building shall be free of infestation by rodents,
birds, insects, and other vermin (other than
laboratory animals). Trash and organic waste matter
shall 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 materials to be used in cleaning the
buildings and facilities; such written procedures
shall be followed.

18. Maintenance
● Weighing, measuring, testing & recording
equipment should be serviced & calibrated
regularly.
● All records should be maintained
● 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.
Equipments and Maintenance
Equipment
● Should be selected based on the intended use and
cleanability.
● Must be placed in an appropriate location.
● Must be properly qualified (design, installation,
operation, performance).
● Constructed so that surfaces are not reactive.
● Automatic, mechanical & electronic equipments
should be calibrated, inspected or checked as per
written program to assure proper performance.
● Computer input/output checked for accuracy.

19. Installation and 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, seam and pressure or vacuum lines,
where applicable, should be installed so as to be
easily accessible during all phases of operation.
They should be clearly identified.
● Support systems such as heating, ventilation, air
conditioning, water, steam, compressed air and
gases should function as designed and
identifiable
Equipments and Maintenance
● Equipment should be designed and located to
suit the production of the product.
Design and construction
● The equipment surfaces coming into contact
with any in process material should not react
with or adsorb 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.

20. Types of Equipments
● Automatic, mechanical or electronic equipment
or other types equipment including computers or
related systems that will perform a function
satisfactorily.
● Appropriate controls shall be exercised over
computer or related systems.
● Filters for liquid filtration used in the
manufacture processing or packing of injectable
drug products intended for human use shall not
release fibres into such products.
Equipments and Maintenance
Equipment cleaning and maintenance
● Equipment and 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
equipment, including utensils, used in the
manufacture, processing, packing, or holding of
a drug product.

21. Thank you
Professor in Pharmaceutics,
Adarsh College of Pharmacy, Vita, Sangli 415311
drkailasmali4u@gmail.com
+91 955 252 7353