Pharmaceutical

Production Management
 PRODUCTION MANAGEMENT
Production management, also called operations
management, planning and control of industrial
processes to ensure that they move smoothly at the
required level.
In manufacturing operations, production management
includes responsibility for product and process design,
planning and control issues involving capacity and
quality, organization and supervision of the workforce.
The ultimate goal of production management is to
produce ‘Quality Drug’
 Quality of Drugs
Generally we take drug to prevent and to treat a disease. If
the drug is therapeutically active and has the capability to
show its credit for the desired reason then we can call the
drug as a quality drug. We should remember that the
elegance as well as appearance can increase the drugs
acceptability.

Aspects of the quality of a drug:

Drug is one of the prime tools for saving lives. A medicinal
product must satisfy certain standards to claim it to be a
quality drug. The main criteria for quality of any drug, in
dosage form, are its
-Safety
-Potency
-Efficacy
-Stability
-Acceptability
-Regulatory compliance
 Quality of Drugs (cont.)

1. Safety: Safety of medicine implies that the drug

substance must meet certain safety requirements
relating to its intended use. The drug related risks
(side effects) are needed to be compared with the
benefits given by that to the patient that is evaluation
of the risk-benefit ratio.

2. Potency: The product must contain adequate drug

substance in its active form. Harmful degradation
products must be absent or below defined limits.
 Quality of Drugs (cont.)
3. Efficacy: A product must be biologically effective. From
its dosage form the drug itself is required to be biologically
available to the recipients.
In case of an established drug substance, the
pharmacopoeial monographs provide basic information on
dosage forms and the dosage, but for a new drug substance
animal test, human volunteer and clinical trials are
necessary to establish the efficacy claim.

4. Stability: The drug substance itself and its dosage form

must be sufficiently stable to retain its minimum potency
recommended by the national or international
Pharmacopoeial monograph.
The finished product must be marketed in suitable
packs to ensure its stability for use up to the expiry date
when stored under specified conditions.
 Quality of Drugs (cont.)
5. Acceptability: Acceptability refers to the consumer or
market acceptability. A product with unpleasant taste is
not normally acceptable; similarly a discoloration though
harmless may not be acceptable to the user.
A medicine should have pharmaceutical elegance for
market acceptability.

6. Regulatory compliance: Each unit pack of the

product must be clearly and correctly labeled. Moreover,
the product must fulfill the regulatory requirements.
Information contained in support of the product such as
potency claim, indications, side effects, precautions,
storage conditions, shelf-life, instructions for use etc must
comply with the drug legislation.
Figure: The Aim for Quality
 Quality Assurance
Quality Assurance is a wide ranging concept which
covers all matters which individually or collectively
influence the quality of a product.
“Quality assurance is the sum total of the organized
arrangements made with the object of ensuring that the
products will be of the quality required for their intended
use.”

The Quality assurance (QA) activity stretches from

product development stage to the use of the product.

QA = Product design + GMP + QC + Quality goal activities

 Objectives of Quality Assurance
Quality Assurance works for the manufacture, packaging
and distribution of products having following objectives:

• Medicinal products are designed and developed in a way

that takes account of the requirements of Good
Manufacturing Practice and Good Laboratory Practice.

• Production and control operations are clearly specified

and Good Manufacturing Practice adopted

• Arrangements are made for the manufacture, supply and

use of the correct starting and packaging materials.

• All necessary controls on intermediate products, and any

other in-process controls and validations are carried out.
 Objectives of Quality Assurance (cont.)

• The product contains the correct ingredients in the

correct proportions and has the purity required.
• Enclosed in its proper container, which bears the
correct label.
• The finished product is correctly processed and
checked, according to the defined procedures,
stored and distributed.
Thus the aim or objective of quality assurance is to ensure
the following intrinsic and extrinsic qualities of a product:

Intrinsic quality Extrinsic quality

Drug substance Appearance of Appearance of

Drug safety
activity product pack

No harmful Pharmaceutical Printing

Drug efficacy
contamination elegance quality

Drug Tamper
Product stability Perceived quality
bioavailability evidence

Moisture Compatibility of Original pack Easy to

protection of the the packing dispensing administer
pack materials
 Quality Control
Quality control is a part of quality assurance. Quality
control refers to the process of striving to produce a perfect
product by a series of measures requiring an organized
effort by the entire company to prevent or eliminate errors at
every stage in production. It concerns quality control of raw
materials, finished products and packaging materials.

QC = Test + Assessment
IN-PROCESS QUALITY CONTROL: The in-process
control is the checks made during the course of
manufacture which aims to ensure that the product will
comply with specifications. The control of the environment
or equipment may also be regarded as a part of in-process
control.
 Quality Control (cont.)

All IPC checks carried out during the manufacturing

process are not part of the final product specifications
although production records need to be checked as a part
of control evidence that the correct operational conditions
are applied during manufacture. For instance:
Maintenance of a certain temperature
Mixing time
Sterilization record
Disintegration / dissolution time
Uniformity of weight
Color and appearance
Moisture content of the in-process material
Hardness
 Quality Control (cont.)

 Thickness
 Friability
 Autoclave pressure
 Aseptic area microbiological quality etc.

All these requirements are not contained in the final

product specifications. Some checks like disintegration
time, average weight etc. appear in the final product
specifications.
Some Commonly Performed IPC Checks: The IPC
checks are designed to ensure that the process is under
control throughout the manufacturing.
Some commonly performed IPC checks are given below:

PROCESS IN-PROCESS CHECKS

1. Dispensing Weighing and Recording.
2. Mixing Time and Speed, Temperature.
3. Granulation Time and Speed, Homogeneity of the content.
4. Drying Temperature (inlet and outlet air), Time, Pressure /
vacuum, Moisture content.
5. Tableting Machine speed, Compression pressure, Thickness,
Hardness, Appearance, Friability, Dissolution / DT.
6. Coating Temperature, Speed, Uniformity and weight.
7. Oral liquids Temperature curve of heating jacket.
8. Ointments Stirrer speed, Process time, Viscosity.
9.Parenteral Bubble point testing of membrane filter, Aseptic area
preparations pressure, Aseptic area microbiological quality.
Can IPC eliminate end-point testing?
Having successfully established an excellent control
over the entire process, the question whether the end
product testing can be waived may still be debatable.
But clearly the trend is towards more extensive in-
process testing with diminishing emphasis on the end
product testing.
Such an objective is no doubt ideal for quality
assurance, the view of the regulatory authorities has
to be considered and also the attitude of a jury in the
event of a claim for damages for injury caused by a
product. Most regulatory authorities still consider the
system of QC laboratory tests for batch release
mandatory as independent checks.
 In manufacturing plants where most processes are
manually controlled the `bulk product release’ test to
specifications should be considered essential as an
independent double check. In the absence of on-line
packing, where the bulk has to be stored, the identity
check of the final pack is also a must to make sure
that the product is in the right pack.

On the whole it can be said that, IPC can diminish the

risk of error in the end point testing but it will not be a
wise decision to eliminate the end-point testing in the
manufacturing process.
 GMP or cGMP
The word GMP stands for ‘Good Manufacturing Practice’ and
cGMP stands for ‘current Good Manufacturing Practice’. The
Drug Authority in the USA formulated the first official
regulations for current Good Manufacturing practice for finished
pharmaceuticals in 1963 which is reviewed and regularly
updated.
WHO defines GMP as “that part of quality assurance” which
ensures that products are consistently produced and controlled
to the quality standards appropriate to their intended use and
as required by the marketing authorization.”
Brief concept:
Pharmaceutical industries + FDA → GMP regulation of 1971
FDA increased surveillance by introducing International Drug
Inspection Program (IDIP) & Drug Enforcement Administration
(DEA).
Purposes of GMP:
To deliver the public of life saving drugs of the highest quality
and purity.
“Quality must be built into a product and cannot be inspected in”
- A serious & particular application in pharmaceutical
production.
QC department can monitor/indicate/help in quality production
but the production department bears the ultimate
responsibility for quality.

Production further supported by engineering dept such as:

-Equipments selection (contact surfaces are not reactive)
-Equipments location (to prevent cross contamination)
-Air quality in sterile operations
-Design and construction of building (for adequate
storage, cleaning, sewage disposal, adequate
portable water).
 GMP GUIDELINES
(A) Personnel: ‘Personnel’ covers the wide range of
people from various departments, whose combined effort
is to build quality product, like- Quality control
department, Production department, Engineering
department etc.
1. The manufacture shall be conducted under the direct
supervision of competent technical staff with
prescribed qualifications and practical experience in
the relevant dosage and / or active pharmaceutical
products.
2. There should be sufficient number of competent
personnel having adequate education, training and
experience to perform assigned functions.
 GMP GUIDELINES (Cont.)

3. The personnel in responsible positions should not have any

interests outside the manufacturer’s organizations that may
prevent or restrict their devotion to assigned responsibilities.
4. All personnel in production area or QC Laboratories shall
receive training appropriate to the duties and responsibility
assigned to them. They shall be provided with regular in-
service training.
The quality of production in one department has an important
effect on the operations of another, and employees should be
trained to understand such relationships.
Example: If the tablet department is producing a product of low
hardness range, in turn causing excessive tablet breakage
during packaging, then one department is transferring
problems to another department, thereby making the problem
more difficult and expensive to correct.
 GMP GUIDELINES (cont.)

(B) Premises: GMP has the far reaching effects on

space allocation for the buildings and equipment to
maintain the concerning issues of quality
manufacturing. It is obvious that the production
department (~45%) and the warehouse (30%)
occupy most of the space of prescription product
manufacturers.
General requirements: Drugs should be stored, labeled
and tested in premises that are suitable for those
purposes. Some general conditions are given below:
1) The compatibility of different manufacturing operations
that may be carried out in the same or adjacent
premises.
 GMP GUIDELINES (cont.)

2) The adequacy of the working space which should allow

orderly and logical placement of equipment and materials to -
a. ensure efficient flow of work and effective
communication and supervision.
b. minimize the risk of confusion between drugs or
their components.
c. control the possibility of cross contaminations.
3) Those physical aspects to be maintained of premises that
could affect the quality and safety of products, such as
a. building should be well designed.
b. interior surfaces (walls, floors and ceilings) should
be smooth.
c. drains should be curved.
4) Penicillin & non-penicillin rooms should be separated.
5) Lighting, heating, ventilation and if necessary, air
conditioning are required to maintain with appropriate level.
 Components of GMP (cont.)
Materials, Lighting, & Air-Conditioning Specifications:
GMP refer to adequate cleaning construction, lighting,
ventilating and other important factors in a production
operation. A choice of materials can be made from an
enormous array of available materials based on:
-Personal preference
-The experiences of other companies
• These decisions are important when a new building is
being designed, but become extremely difficult in the
redesigning of an old facility where some other extra
precaution must be taken into consideration as like
wooden floors, ceiling height, other outmoded features.
• In the selection of construction materials, initial costs are
only a partial consideration, since maintenance enters
into total cost.
 Components of GMP (cont.)
The selection of materials for walls, floors, and ceilings
should be done which have proven years of durability.
For example, for the floors in weighing, granulation,
tableting, coating, liquid manufacturing, packaging &
warehousing areas ‘high-density concrete’ and ‘concrete
metal chips’ have proven durable.
The selection of decorating colors in the manufacturing
and office areas is important, especially in plants with few
or no windows.
The sectional use of different colored paints in long
corridors avoids a tunnel-like impression.
The hanging of washable wallpaper in such as the
packaging room provides both pleasant surroundings and
low maintenance costs.
 GMP GUIDELINES (cont.)

Specific requirements:
Storage area: There should have-
1) Adequate space and lay out to permit effective
and orderly segregation of the various categories of
materials.
2) Quarantine area for incoming goods as a
safeguard that goods can not be used before
release by the QC department.
3) Special segregated area for:
a. substance or products to be stored at
low temperature.
b. highly toxic and narcotic drugs.
c. substances with explosive power.
 GMP GUIDELINES (cont.)
Production areas:
1) Close to the working area, changing room should be
installed with facilities related to the type of work to be done.
2) Adjacent to every production, section room should be
available for washing equipment and for disinfection if
necessary.
3) In the solution department adequate draining system should
be available.
4) In tablet section, segregated room should be available for
all successive unit operations.
5) In the area of capsule production the R.H. of air should be
constant (40% or less).
6) Adequate dust extraction system where necessary.
7) Aseptic room environment for aseptically filled sterile
products and almost similar environment except sterile air
supply for terminally sterilized products.
 GMP GUIDELINES (cont.)

(C) Equipments:
a.Design and construction:
1.The design and construction of the equipment should be
suitable for its intended use and easy to clean.
2. The equipment material should be minimally reactive,
additive or adsorptive with respect to the materials/drugs to
be processed.
b. Location and installation:
1. The equipment should be located and installed to –
-minimize cross contamination of materials.
-minimize confusion or omission of any processing step.
-avoid congestion.
2.Every equipment should be marked with an identifying
mark. Each equipment shall be provided with a logbook,
wherever necessary.
 GMP GUIDELINES (cont.)

c. Weighing and measuring equipments:

Balances and other measuring equipment of an
appropriate range, accuracy and precision shall be
available in the raw material stores, production and in
process control operations.
Equipments used for weighing / measuring should
be calibrated and standardized at regular time
intervals by standardized / calibrated recordings.
d. Cleaning and maintenance:
Equipment should be thoroughly cleaned and when
necessary, sterilized, and should be maintained in
accordance with specific written directions.
Defective equipment shall be removed from
production and Quality Control areas.
 GMP GUIDELINES (cont.)
(D) Sanitation / Hygiene:
1) Good personnel hygiene is a primary condition
requires adequate washing facilities before
entrance into a production area.
2) Manufacturing premises, facilities equipments and
materials should be regularly cleaned and
maintained in accordance with sanitary standards.
3) Manufacturing personnel should be in good health
and maintain required hygienic standards. They
should be medically examined periodically, at least
once a year.
4) All personnel shall wear clean body coverings
appropriate to their duties.
 GMP GUIDELINES (cont.)

5) Sufficient clean, well-ventilated toilet facilities

should be available.
6) Smoking, eating and drinking should be strictly
prohibited in working areas.
7) Cyclone collector, wet scrubbers, replaceable
filters, cloth bags, HEPA filters or combination of
some of these should be used to prevent dust or
cross contamination.
Cross Contamination constitutes an ever present
danger in pharmaceutical manufacturing.
Identification and removal of its causes have had a
profound effect on plant layout as well as on the
design and construction of production areas.
 Components of GMP (cont.)

Wet Collector:
- A ‘wet scrubber’ operates by mixing the dust-laden air
stream with water in an enclosed chamber, which discharges
the effluent into the sewer or treatment plant.
- A ‘Rotoclone’ operates by spraying the air in the collector
and mixing it by means of high-speed paddles. This type of
scrubber is efficient and uses a minimal amount of water.

Both systems are particularly effective when a dye is used as

the component of dosage form, and it is therefore necessary
to prevent trace quantities from contaminating nearby
operations.
These can also be used when water-soluble, volatile solvents
are used in pharmaceutical manufacturing, since the
entrained vapors are diluted with water to a safe level of
concentration.
 Components of GMP (cont.)
Filters, Bags and High-efficiency Particulate Air Filter:
The most commonly used dust collectors are the replaceable
filter, cloth bag and HEPA types. In large operations, the
collectors are placed on the roof. HEPA filters are effective at
100% in particle ranges of a few microns.
At one time HEPA filters were used exclusively in sterile
operations to reduce particulate matter. The current
emphasis on reducing cross-contamination, has resulted in
their use in many dry product operations, such as:
Granulating, Tableting, Capsule filling etc.
The handling of products containing attenuated viruses
requires the use of HEPA filters with no return air circulation
as a minimum precaution, when viable pathogenic viruses or
other dangerous organisms are being processed, it is best to
incinerate all exhaust air at a temperature above 8000F.
 GMP GUIDELINES (cont.)

E) Starting material:
1) An inventory should be made for all
necessary materials.
2) The supplier should be chosen with care
since his information is important for the
judgment of quality.
3) A starting material should be used only after
assessing by QC that it conforms to specified
standards.
 GMP GUIDELINES (cont.)

(F) Manufacturing operation:

1)There should be well established written procedures
for manufacturing operations.
2)Before any operation is started it should be checked
by the supervisor that the apparatus have been cleaned
and no materials or other than those required for the
operation concerned, are present.
3) All vessels, containers and equipments used in
the manufacturing process should be labeled for
identification.
4) No simultaneous manufacture of different
products in one room should be allowed.
5) All operations should be recorded by the worker.
6) In-process controls should be carried out.
 GMP GUIDELINES (cont.)

(G) Packaging and labeling:

1) Packaging materials and in particular printed
material should be issued in quantities related to
the bulk to be filled.
2) A surplus of printed packaging materials may
never be returned to the stock.
3) Every filling, packaging or labeling action should
begin with an inspection.
4) Products of similar appearance should not be
handled at the same time in one room.
 GMP GUIDELINES (cont.)
(H) Quality control system:
1.The QC department should have adequately staffed and
fully equipped laboratory for performing all quality control
tests on starting materials, intermediate bulk, finished
products and the environment of manufacturing,
packaging or storage areas.
2. The department should establish authorized
specifications regarding raw and packaging materials,
finished products and environment.
3. The department should carry out a stability test program
and establish specifications on expiry date and storage
condition of the materials and products.
4. The department should authorize instructions for
sampling, analysis, storage and in-process control.
 GMP GUIDELINES (cont.)

5. All instruments shall be calibrated and testing procedures

validated before these are adopted for routine testing.
6. Sufficient samples of starting materials & products must
be retained to permit future examination of the product if
necessary.
7. The IPC checks are designed to ensure that the process
is under control throughout the manufacturing. The control
of the environment or equipment may also be regarded as a
part of IPC.
8. The department is responsible for release or rejection
of materials and products.
9. The department should maintain adequate analytical
records concerning the examinations of all samples taken.
 GMP GUIDELINES (cont.)
(I) Documentation: Documentation is necessary –
a) for easy availability of all data required for manufacturing,
packaging and QC.
b) to record the history of a batch to permit investigation and
tracing of defective products.
c) to reduce the risk of mistakes inherent in verbal
communication.
Documentation comprises at least:
1) Specifications of all starting materials, packaging materials
and products.
2) Prescriptions and instructions for all manufacturing,
packaging and testing procedures, cleaning and disinfection,
maintenance of equipment, monitoring of working conditions
and use of specific dressings etc.
3) Records including batch manufacturing records, batch
packaging records, test records and records of non-product
related operations, like cleaning, disinfection, maintenance etc.
GMP Guidance to Pharmaceutical Manufacturing
Facilities
Weighing area
The first important step in the manufacturing process has been
receiving an increasing attention because of possibilities for
cross-contamination and misbranded products due to incorrect
ingredients or quantities. Many companies have adopted a
central weighing department to service all of the processing
areas.
Advantages of Central Weighing Department:
-Centralization of responsibility
-Avoidance of duplicating weighting facilities
-Lower labor costs
A chemical weighing department should be designed to
provide: Proper weighing equipment, Lighting, Dust collection,
Supervision, Checkers and Adequate sanitation.
-High potency drugs such as steroids and alkaloids
should be weighed in a separate room equipped with
absolute filters to avoid even minimal cross
contamination.
-Sinks and drain boards should be conveniently located
to facilitate frequent cleaning of measuring equipment.
-Cabinets should be provided for the storage of
utensils.
-Vacuum hoses should be available in the weighing
area immediately adjacent to the weighing booths so
that the tops of drums and other containers can be
cleaned free of dust before they are opened for
removal of contents.
-Balances and scales having the proper capacity and
sensitivity needed for weighing operations should be
specified, and arrangements made for frequent
calibration.
-Printing scales that record weights on formula sheets
and container labels should also be provided.
-Meters should be used when liquid materials are
transferred from storage tanks directly to
manufacturing tanks. Each quantity should be
recorded on batch sheets, either manually or by
means of a printing system. The meters should be
calibrated and checked periodically.
 Tablet Granulating Area
In general, several different products are in production at any
given time, the numerous steps in the granulating
procedure increase the possibilities of cross-contamination,
incorrect product identification and/or mix-ups. To eliminate
these possibilities, a separate room or booth is
recommended for each step.
Compartmentalizing the granulating process needs more
fragments in the operation space increases space, capital
and labor costs.

Granulating should be considered a unit operation

composed of closely integrated manufacturing steps and
process development work should be directed to this area
for cost reduction and process improvement.
A washing facility should be available for cleaning portable
equipment. To facilitate cleaning of nonportable equipment,
each room should be provided with
-Floor drains
-Pitched floor
-Hot water
-Cold water
-Steam
Particular attention should be devoted to the cleaning of
drying racks and trays, which should be designed for easy
cleaning and made of stainless steel or other non rusting
material.
If the department is not air-conditioned, all windows should be
screened against the entrance of insects.
 Tablet Compression Area
Booths or Rooms:
Separate rooms for tablet machines necessary to avoid cross
contamination.
When special low humidity conditions are necessary to
ensure product stability, the room is kept satisfactory for
relative humidity levels below 20%. Such rooms should have
special low vapor transmission treatment of walls and
equipped with air locks.
The compression rooms can all be the same size or vary in
size to accommodate the smallest and largest presses. The
booth walls should extend from floor to ceiling.

Space should be provided for in-process equipment such as

balances and tablet hardness testers.
Tablet Presses:
A room should be made available nearby for
the cleaning of presses and replacement of
punches and dies for the next product.
Each press should be mounted on metal
frames so that it can be moved by lift trucks
into a cleaning area and replaced by one
that has been cleaned and prepared for the
next product.
The exact number of tablets produced is
compared to the expected yield by a process
called ‘reconciliation’. A major discrepancy
between theoretic and actual yields signifies
that an error may have been introduced at
some stage of the procedure. To discover the
discrepancy, rotary presses should be
equipped with automatic counters.
 Tablet Coating Area
Traditionally, tablet coating has been considered an art
and has required a rather lengthy apprenticeship. The
process is noisy and dusty, and it is a labor consuming
and somewhat inefficient procedure.
In recent years, a number of technologic developments
have introduced some automated techniques. The
developments are increased pan sizes, improved drying
cycles and automated spray coating.
These technologic changes have necessitated a new
approach to the design and layout of a coating
department. For example, enclosing pans offer some
advantages like low noise.
Polishing should be isolated from the general coating
operation.
Solvent laden exhaust should be sufficiently
diluted with air to meet fire and environmental
standards of safety.
Sufficient floor drains should be provided for
adequate cleaning of floors and equipment
because of generating of dust and use of dye.
Pumps should be used for the transfer of wash
water from coating pans to either floor drains or
nearby sink.
If coated tablets are imprinted with a monogram
or a product identification number, each printing
machine should be in a separate booth to avoid
cross contamination.
For inspection of coated tablets, the inspection
equipment should be placed in separate
booths.
 Area for Manufacturing of Liquids
Separate facilities are used for oral, external and cosmetic
preparations. If not possible a separating wall should be
constructed to isolate one group from another to avoid
cross contamination and the transference of odors.

Special attention should be given to the design and

installation of equipment and washing facilities for those
drug that are susceptible for microbiological
contamination.

Sanitary pumps and fittings should be used together with

stainless steel tubing with snap on connections to facilitate
easy removal and cleaning.
Potable water is necessary in all operations.
So deionizers and other water treatment
equipment are used and routine microbiologic
and chemical testing should be done.

If the same tanks are used to manufacture

more than one product, liquid meters and tank
calibrations are important to product
reconciliation.

Manufacturing tanks should be located far

away from each other to avoid cross
contamination. The elevated platforms should
be sufficiently large to permit the positioning of
pallets or raw materials around the tanks and
still provide sufficient room for the separation
of adjoining tanks.
 Packaging Area
Packaging lines should be far enough apart to prevent cross
contamination, product mixup.
U shaped lines are preferable due to eliminates noise, heavy
traffic, and paper dust and reduce air conditioning loads in the
packaging department.
Roll labels have many advantages over cut levels in avoiding
mislabeling or label mixups in either the label printing
operations or the storage and handling of labels in packaging.
Labels should be stored in an air conditioned room and in
winter, relative humidity should be controlled of about 50% to
avoid overdrying of labels.
Room should have sufficient space for storage of approved
and unapproved labels and inserts.
Department should be equipped with an
adequate number of sinks to permit washing of
measuring utensils and packaging line
equipment parts.
Cleaning of dry products filling equipment by
vacuum or compressed air should be conducted
during shutdown hours for avoid cross
contamination.
Space should be available for use by
departmental or quality control line inspectors
and in process testing equipment and also
cabinets should be provided for clean utensils
and parts.
Staging area should be available for the storage
of packaging equipment not in use and machine
change parts.
 Warehousing
Special attention should be focused on
maintaining cleanliness, freedom from
infestation and orderliness.
The entire warehousing area should be
cleaned as often as necessary to
maintain sanitary conditions.
A quarantine area for incoming raw
materials and packaging components is
necessary and an enclosed quarantine
area must be provided for rejected raw
materials, packaging components, bulk
products and finished goods.
 Shipping and Receiving
Constant movement of materials in & out of the building
subjects this area to the greatest possibility of insect &
rodent infestation.
Air curtains have been used to prevent flying insects
from coming into the building.
Inside dock should be large enough to permit both the
trailer and the tractor to park inside the building.
Overhead doors can be used to close off the dock area.
Only approved finished goods should be kept in the
shipping area.
Items awaiting quality control approval should be kept in
the quarantine area.
Alcohol and other combustible solvents should be stored in
explosion proof rooms equipped with special fire protection
facilities.
Approved vaults must be used for storage of finished
goods, raw materials of narcotics and other dangerous
drug.
Sampling booth should be provided adjacent to the
receiving dock for statistical inspection and the sampling of
raw materials and finishing suppliers.
Dust collection hoses should be provided to clean the tops
of containers prior to placement in the general warehouse.
An inspection center immediately adjacent to the receiving
dock should be provided where facilities for the examination
of incoming materials are made available.
 Cost Control in Manufacturing
GMP is a set of guidelines that ensure product safety,
quality & efficacy are constantly being met through a
well designed plant, skilled personnel and required
environmental conditions.

GMP reduces manufacturing cost by the following ways-

1. Creating the best facilities and selecting the best
equipment according to GMP requirements reduces
the long term high maintenance cost.
For example, it is best to invest in the right type of
flooring for a particular area rather than incur high
annual maintenance cost in cleaning or patching
floors not properly specified for that area.
2. GMP necessitates personnel of various departments
who in collaboration can
-make a good quality manufacturing facility like the
proper and effective installation of the buildings and
equipments which prevents extra cost and wastage
-operate a quality manufacturing cycle

3. GMP outlines the plant layout as well as the design and

construction of production areas to avoid cross
contamination and mix-ups which are the ever dangers
in pharmaceutical manufacturing, so unwanted and
accidental costs are reduced.
4. GMP imposes training need for the employee
which makes them skilled on their works thus
increasing efficiency and reducing cost.

5. GMP outlines cleanliness, adequate lighting and

air conditioning in every section of manufacturing
as necessary, so the process becomes smooth
and proper which in turn reduce the cost of extra
maintenances and hazards.