AN ASSIGNMENT ON

CGMP & INDUSTRIAL

MANAGEMENT
SUBMITTED BY
CH RAJESH KUMAR NAYAK
M.PHARM (PHARMACUETICS)
REGD. NO.- 1902853026
MOB- 8598908660
COLLEGE OF PHARMACEUTICAL & SCIENCES
BERHAMPUR
 CONTENT
1. OBJECTIVE
2. POLICIES
• Quality management system
• Personnel
• Organization, Qualification and Responsibilities
• Training
• Premises
• Equipment
• Sanitation and Hygiene
• Production
3. LAY OUT OF BUILDINGS
• Types of buildings
 Circular flow
 Parallel flow
 Crossover traffic
• Buildings and facilities
THE OBJECTIVES & POLICIES OF CGMP
 Ensure that products are consistently manufactured and controlled
to the specified quality.
 Concerned with all aspects of production and quality control.
 In the manufacture of cosmetic products, overall control and
monitoring
 Ensure that the consumer receives products of specified quality.
 The quality of a product depends on the starting materials,
production and quality control processes, building, equipment
and personnel involved.

1. Quality Management System

 A quality system should be developed, established and implemented
as a means by which stated policies and objectives will be achieved.
 It should define the organizational structure, functions,
responsibilities,
 procedures, instructions, processes and resources for implementing
the
 quality management.
 The quality system should be structured and adapted to the
company’s activities and to the nature of its products and should
take into consideration appropriate elements stated in this
Guidelines.
 The quality system operation should ensure that if necessary,
samples of starting materials, intermediate, and finished products
 are taken, tested to determine their release or rejection on the basis
of test results and
 other available evidence related to quality.
2. Personnel
 There should be an adequate number of personnel having
knowledge, experience, skill and capabilities relevant to their
assigned function.
 They should be in good health and capable of handling the duties
assigned to them.
3. Organization, Qualification and Responsibilities
 The production and the quality control sections should be headed
by different persons
 The head of production should be adequately trained and
experienced in drug/food/cosmetic manufacturing.
 He should have authority and responsibilities to manage production
of products covering operations, equipment, production personnel,
production areas and records.
 The trained head of quality control area should be given full
authority and responsibility in all quality control duties such as
establishment, verification and implementation of all quality control
procedures.
 He should have the authority to designate/assign personnel, to
approve starting materials, intermediates, bulk and finished products
 The responsibilities and authority of key personnel should be clearly
defined.
  An adequate number of trained personnel should be appointed to
execute direct supervision in each section of the production and the
quality control unit.

4. Training
 All personnel directly involved in the manufacturing activities
should be appropriately trained in manufacturing operations in
accordance to GMP principles.
 Special attention should be given to training of personnel working
with any hazardous materials
 Training in GMP should be conducted on a continuous basis.
 Records of training should be maintained and its effectiveness
assessed periodically.
5. Premises
 The premises for manufacturing should be suitably located,
designed, constructed and maintained.
 Effective measures should be taken to avoid any contamination from
the surrounding environment and from pests.
 Household products containing non-hazardous
materials/ingredients and cosmetic products can share the same
premises and equipment provided that due care should be exercised
to prevent cross contamination and risk of mix-up.
 Painted line, plastic curtain and flexible barrier in the form of rope
or tape may be employed to prevent mix-up.
 Appropriate changing rooms and facilities should be provided.
Toilets should be separated from the production areas to prevent
product contamination/cross contamination.
 Defined areas should be provided for, wherever possible and
applicable:
 Defined areas should be provided for, wherever possible and
applicable:
 Materials receiving.
 Material Sampling
 Incoming goods and quarantine.
 Starting materials storage.
 Weighing and dispensing.
 Processing.
 Storage of bulk products
 Defined areas should be provided for, wherever possible and
applicable:
 Quarantine storage before final release of products.
 Storage of finished products.
 Loading and unloading.
 Laboratories.
 Equipment washing.
 Packaging.
 Wall and ceiling, where applicable should be smooth and easy to
maintain.
 The floor in processing areas should have a surface that is easy to
clean and sanitize.
 Drains should be of adequate size and should have trapped gullies
and proper flow.
 Open channels should be avoided where possible, but if required
they should be able to facilitate cleaning and disinfection.
 Air intakes and exhausts and associated pipework and ducting, when
applicable, should be installed in such a way as to avoid product
contamination.
 Buildings should be adequately lit and properly ventilated
appropriate to the operations. .
 Pipework, light fittings, ventilation points and other services in
manufacturing areas should preferably be installed in such a way as
to avoid uncleanable recesses and run outside the processing areas.
 Laboratories should preferably be physically separated from the
production areas.
 Storage areas should be of adequate space provided with suitable
lighting, arranged and equipped to allow dry, clean and orderly
placement of stored materials and products.
 Such areas should be suitable for effective separation of quarantined
materials and products.
 Special and segregated areas should be available for storage of
flammable and explosive substances, highly toxic substances,
rejected and recalled materials or returned goods.
 Where special storage conditions e.g. temperature, humidity and
security are required, these should be provided.
 Storage arrangements should permit separation of different labels
and other printed materials to avoid mix-up.
6. Equipment
 Equipment should be designed and located to suit the production of
the product.
A. 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.
B. 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, steam 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
(such as potable, purified, distilled), steam, compressed air and
gases (example nitrogen) should function as designed and
identifiable.
C. Maintenance
 Weighing, measuring, testing and recording equipment should be
serviced and calibrated regularly.
 All records should be maintained.
7. Sanitation and Hygiene
 Sanitation and hygiene should be practiced to avoid contamination
of the manufacturing of products. It should cover personnel,
premises, equipment/apparatus and production materials and
containers.
A. Personnel
 Personnel should be healthy to perform their assigned duties.
 Regular medical examination must be conducted for all production
personnel involved with manufacturing.
 Any personnel shown at any time to have an apparent illness or open
lesions that may adversely affect the quality of products should not
be allowed to handle raw materials, packaging materials, inprocess
materials, and finished products.
 Personnel should be instructed and encouraged to report to their
immediate supervisor any conditions (plant, equipment or
personnel) that they consider may adversely affect the products.
 Direct physical contact with the product should be avoided to ensure
protection of the product from contamination. Personnel should
wear protective and clean attire appropriate to the duties they
perform.
 Smoking, eating, drinking and chewing, , food, drinks and smoking
materials and other materials that might contaminate are not
permitted in production, laboratory, storage or other areas where
they might adversely affect product quality.
 All authorized personnel entering the production areas should
practice personal hygiene including proper attire.
B. Premises
 Adequate employee's washing and well ventilated toilet facilities.
 Should be provided and separated from the production area.
  Suitable locker facilities should be provided at appropriate location
for the storage of employees' clothing and personal belongings.
 Waste material should be regularly collected in suitable receptacles
for removal to collection points outside the production area.
 Rodenticides, insecticides, fumigating agents and sanitizing
materials must not contaminate equipment, raw materials,
packaging materials, in-process materials or finished products.
C. Equipment and Apparatus
 Equipment and utensils should be kept clean.
 Vacuum or wet cleaning methods are preferred.
 Compressed air and brushes should be used with care and avoided
if possible, as they increase the risk of product contamination.
 Standard operating procedures must be followed for cleaning and
sanitizing of major machines.

8. Production
A. Water
 Water systems should be sanitized according to well established
procedures.
 The chemical and microbiological quality of water used in
production should be monitored regularly, according to written
procedures and any anomaly should be followed by corrective
action.
 The choice of method for water treatment such as de ionization,
distillation or filtration depends on product requirement.
 The storage as well as delivery system should be properly
maintained.
B. Verification of materials
 All deliveries of raw materials and packaging materials should be
checked and verified for their conformity to specifications and be
traceable to the product.
 Samples of raw materials should be physically checked for
conformity to specifications prior to release for use.
 The raw materials should be clearly labeled.
 All goods must be clean and checked for appropriate protective
packing to ensure no leakage, perforation or exposure.
C. Rejected materials
 Deliveries of raw materials that do not comply with specification
should be segregated and disposed according to standard operating
procedures.
D. Batch numbering System
 Every finished product should bear a production identification
number which enables the history of the product to be traced.
 A batch numbering system should be specific for the product and a
particular batch number should not be repeated for the same product
in order to avoid confusion.
 Whenever possible, the batch number should be printed on the
immediate and outer container of the product.
 Records of batch number should be maintained.
E. Weighing and Measurement
 Weighing should be carried out in the defined areas using calibrated
equipment.
 All weighing and measurement carried out should be recorded and ,
where applicable, counterchecked.
F. Procedure and Processing
 All starting materials used should be approved according to
specifications.
 All manufacturing procedures should be carried out according to
written procedures all required in-process controls should be carried
out and recorded.
 Bulk products should be properly labelled until approved by Quality
Control, where applicable.
 Particular attention should be paid to problem of cross-
contamination in all stages of processing.

LAYOUT OF BUILDINGS
Designed according to c GMP practice which ensures
 Prevention of cross contamination
 Proper air handling system
 Proper cleaning and sanitary facilities
 Proper lighting
 Proper plumbing & proper washing
 It is the organized planed Interdepartment and Intradepartment
arrangement.
 Proper layout.
 Increase productivity.
 Helps in proper utilization of
1. Man 3. Machine
2. Material 4. Money
Types of layouts
 Circular flow
 Parallel flow
 Crossover traffic
Buildings and facilities:
A. Design and Construction:
 Typically the bays in industrial buildings have frames spanning the
width direction. Several such frames are arranged at suitable spacing
to get the required length (Fig. 2.1).
 Depending upon the requirement, several bays may be constructed
adjoining each other. The choice of structural configuration depends
upon the span between the rows of columns, the head room or
clearance required the nature of roofing material and type of
lighting.

 If span is less, portal frames such as steel bents (Fig. 2.2a) or gable
frames (Fig. 2.2b) can be used but if span is large then buildings
with trusses (Fig. 2.2 c & d) are used.
 The horizontal and vertical bracings, employed in single and multi-
storey buildings, are also trusses used primarily to resist wind and
other lateral loads. These bracings minimize the differential
deflection between the different frames due to crane surge in
industrial buildings. They also provide lateral support to columns in
small and tall buildings, thus increasing the buckling strength.
B. Floors :
 Different types of floor are required in any factory from their use
consideration such as production, workshop, stores, amenities, and
administration.
 The service condition will vary widely in these areas, so different
floors types are required. Industrial floors shall have sufficient
resistance to abrasion, impact, acid action and temperatures
depending on the type of activity carried out.
 High strength and high performance concretes can satisfy most of
these requirements economically and is the most common material
used.
 Foundation for vibrating machinery (such as reciprocating and high
speed rotating machinery) should be placed upon rock or firm
ground and it should be separated from adjacent floor to avoid
vibrations.
C. Roof System :
 .While planning a roof, designer should look for following quality
lightness, strength, water proofness, insulation, fire resistance, cost,
durability and low maintenance charges. Sheeting, purlin and
supporting roof trusses supported on column provide common
structural roof system for industrial buildings. The type of roof
covering, its insulating value, acoustical properties, the appearance
from inner side, the weight and the maintenance are the various
factors, which are given consideration while designing the roof
system. Brittle sheeting such as asbestos, corrugated and trafford
cement sheets or ductile sheeting such as galvanized iron corrugated
or profiled sheets are used as the roof covering material. The
deflection limits for purlins and truss depend on the type of sheeting.
For brittle sheeting small deflection values are prescribed in the
code.
D. Water:
 Water used in the manufacture of APIs should be demonstrated to
be suitable for its intended use. Unless otherwise justified, process
water at a minimum should meet World Health Organization(WHO)
guidelines for drinking (potable) water quality.
 If drinking (potable) water is insufficient to ensure API quality and
tighter chemical and/or microbiological water quality specifications
are called for, appropriate specifications for physical/chemical
attributes, total microbial counts, objectionable organisms, and/or
endotoxins should be established.
 Where water used in the process is treated by the manufacturer to
achieve a defined quality, the treatment process should be validated
and monitored with appropriate action limits.
E.Containment(Dedicated Production area):
 Dedicated production areas, which can include facilities, air
handling equipment and/or process equipment, should be employed
in the production of highly sensitizing materials, such as penicillin's
or cephalosporins.
 The use of dedicated production areas should also be considered
when material of an infectious nature or high pharmacological
activity or toxicity is involved (e.g., certain steroids or cytotoxic
anti-cancer agents) unless validated inactivation and/or cleaning
procedures are established and maintained.
 Appropriate measures should be established and implemented to
prevent cross-contamination from personnel and materials moving
from one dedicated area to another.
 Any production activities (including weighing, milling, or
packaging) of highly toxic nonpharmaceutical materials, such as
herbicides and pesticides, should not be conducted using the
buildings and/or equipment being used for the production of APIs.
Handling and storage of these highly toxic nonpharmaceutical
materials should be separate from APIs.
F. Lighting:
 Adequate lighting should be provided in all areas to facilitate
cleaning, maintenance, and proper operations. (Fig.2.3)

G. Sewage and Refuse:

 Sewage, refuse, and other waste (e.g., solids, liquids, or gaseous by-
products from manufacturing) in and from buildings and the
immediate surrounding area should be disposed of in a safe, timely,
and sanitary manner. Containers and/or pipes for waste material
should be clearly identified.
H. Sanitation and Maintenance:
 Buildings used in the manufacture of intermediates and APIs should
be properly maintained and repaired and kept in a clean condition.
 Written procedures should be established assigning responsibility
for sanitation and describing the cleaning schedules, methods,
equipment, and materials to be used in cleaning buildings and
facilities, they should also be established for the use of suitable
rodenticides, insecticides, fungicides, fumigating agents, and
cleaning and sanitizing agents to prevent the contamination of
equipment, raw materials, packaging/ labeling materials,
intermediates, and APIs.