A REVIEW ON R&D, PRODUCTION,

Q.C, Q.A AND ENGINEERING

DEPARTMENTS OF NATCO
PHARMA, KOTTUR, HYDERABAD

Under the guidance of Dr. K. MANOHAR BABU, M.Pharm., Ph.D.,

Presented by:
D. ALEKHYA,
G. V. K. SRAVANI,
M. PRAVALLIKA,
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P. JASMINE CAREY
 CONTENTS
1) Company history
2) Introduction
3) Research and development department
4) Production department
5) Manufacturing of capsules
6) Quality control department
7) Quality assurance department
8) Engineering department
9) Conclusion
10) References
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 1. Company History:
 The NATCO Pharma was promoted by V C Nannapaneni in the year
1981 as a private company to be in the business of research,
developing, manufacturing and marketing of pharmaceutical
substances and finished dosage forms for Indian and International
markets.
 The company begans its operation in 1984 in Andhra Pradesh. The
company’s first product was cardicap, which is an anti-anginal drug.
 It manufacturing drugs for Cardiovascular, Anti-cold, Anti-asthmatic,
Anti-cancer drugs and Antibiotics.
 The company is part of the NATCO pharma group and has
manufacturing facilities located all over india. NATCO’s various
product brands include Desifer, Veenat, Bendit, Bortenat, Lenalid,
Alphalan, Lymfuda, Clokeran, Bandrone, etc.,

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 2. Introduction:
Pharmaceutical industry discovers, develops, produces and
markets drugs or pharmaceuticals use as medications.
Pharmaceutical companies may deal in generic or brand medications
and medical devices. We trained in the areas of various departments
in NATCO Pharma company gives us following information about
equipment and functioning of every department regarding
manufacturing of solid dosage forms.
 R&D
 Production
 Quality Control
 Quality Assurance
 Engineering

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 3. Research & Development:
Research & Development can be defined as any project to resolve
scientific or technological uncertainty aimed at achieving an advance in
science or technology.
It is creative work undertaken on a systemic basis in order to increase the
stock of knowledge including search of new molecules, synthesis and
modification of known molecules or some methods to increase production
rate by adopting different techniques.
In R&D department for development of the formula various equipments
are used for manufacture of solid dosage forms like:
 Compression machine
 Hardness tester
 Disintegration apparatus
 Dissolution apparatus
 Sieve shaker

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 Compression machine:
The compression machine used in R&D department of Natco
company was ELIZA PRESS.
 Eliza press is a tablet rotary press. It is a mechanical device with multiple
punches that rotates to compresses the powder into tablets of uniform size
with different shape and uniform weight to yield more number of tablets
than single punch machine.

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 Hardness tester:
The hardness tester used in R&D department of Natco company was
Schleuniger pharmatron.
 Dr. Schleuniger pharmatron is a global leader in solid dosage form
testing and specializes in complete tablet hardness testing solutions for
measuring weight, thickness, diameter and tablet hardness.

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 4. Production:
Production is the functional area responsible for turning inputs into
finished outputs through a series of production processes. Manager is
responsible for making sure that raw materials are provided and made into
finished goods effectively.
 Before entering into the production there must be a proper gowning to the
persons who are working in the production.
GOWNING:
The process of wearing special garments such as head covers, gloves, shoe
covers in order to control particulate contamination.
It includes:
 Primary gowning
 Secondary gowning

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 5. Manufacturing of capsules:
In pharmaceutical company mainly production department
includes some equipments for manufacture of capsules like:
A. Granulator
B. Tray drying
C. Coating pans
D. Capsule filling machine
E. Blister packing machine

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 A. Rapid mixer granulator
In rapid mixer granulator,
formation of granules occurs
by rising, whirling and
tumbling motion of material.
Dry mixing is done by adding
all ingredients in to the RMG
by rotation of impeller and
chopper at high speed.
Impellers
Choppers
Discharge port
During the addition of binder
solution to the powder the
impeller and chopper are
operated at low speed.
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 B. Tray
dryer
In tray dryer, hot air is
continuously circulated. Forced
convection heating takes place
to remove moisture from the
solids placed in trays.
Simultaneously, the moist air is
removed partially.
The hot air is circulated by
means of fans at 2-5 meter per
second.
Thus constant temperature
and uniform airflow over the
material can be maintained for
achieving uniform drying.

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 C. Coating pans:
Coating is defined as technique of
applying a solution of coating material
to the external surface of dosage form
Coating of a dosage form is required to
mask the taste of a drug and to
increase the chemical stability of
dosage form.
Coating solutions are applied to
capsules by spraying.
Use of atomizing system to produce
even distribution of coating solution.

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 D. Automatic capsule filling
machine:
The capsule shells are filled
with desired medicaments.
 The main principle involved
in the automatic capsule filling
machine is auger principle which
involves in separation of capsule
shell, filling of medicament into
capsule body and rejoining of
capsule shell by applying
vacuum. Some steps involved
are:
 Capsule Orienting & Loading
 Powder filling
 Capsule closing & Ejection

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 E. Blister packing machine:
Packing has to be carried
out for the purpose of the
safety of pharmaceutical
preparations in order to keep
them free from contamination
and to ensure product safety
and shelf life.
 Blister packs secure to
protect products from moisture
and gas, to ensure a long shelf
life.
 It is cost effective and easy
to use.

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 6. Quality Control:
Quality control is a procedure intended to ensure that a
manufactured product or performed service adheres to a defined set
of quality criteria or meets the requirements of the client or
customer. QC is similar to, but not identical with Quality
Assurance.

A. HPLC
B. GC
C. Disintegration apparatus
D. Karl- Fischer titrate
E. Dissolution apparatus
F. Stability chamber

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 A. High Pressure Liquid Chromatography:
 HPLC is a chromatographic
technique in which high
pressure is used for separation
of compounds.
 It is a modified type of liquid
chromatography in which the
sample is bounded with
stationary phase in a column
and gets separated by liquid
mobile phase by gravity.
 The HPLC important
application is the separation
and analysis of non-volatile or
thermally-unstable compounds

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 Components in HPLC:
HPLC has 5 main components. They are:
1. Pump: the pump module used in HPLC are either isocratic or
gradient.
2. Injector: serves to introduce the liquid sample into flow
stream of mobile phase.
3. Column: is considered as heart of the chromatograph which is
a long, thin consists of tiny solids as stationary phase.
4. Detector: serves to measure the amount of individual
molecules that are eluted from column.
5. Computer: takes signal from detector and uses to determine
time of elution or retention time.

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 B. Gas chromatography:
 It is used in analytical chemistry for
separating and analysing
compounds that can be vapourised
without decomposition.
 In this mobile phase is a inert carrier
gas such as helium, nitrogen or any
un reactive gas.
 Stationary phase is a microscopic
layer of polymer present in a piece
of glass or metal tubing called as
column.
 Gas chromatography is also known
as Vapor-phase chromatography
(VPC), or Gas-liquid partition
chromatography (GLPC).
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 C. Disintegration apparatus:
 Disintegration is defined as the
breakdown of solid dosage form into
small particles after it is ingested.
 It is the state in which no residue of the
unit under test remains on the screen of
the apparatus except fragments of
disintegrated parts of solid dosage form.
 The main importance of disintegration is
to increase bioavailability of drug for
absorption in the body.

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 D. Karl Fischer titrate:
 Karl Fischer titration is a method
in analytical chemistry that uses
coulometric or volumetric titration to
determine trace amounts of water in a
sample.
 This method is used for determination of
moisture content in sample or non
aqueous liquids or if the moisture present
in sample cant be removed by heating or
extraction.
 The end point may be detected by a
bipotentiometric method.
 The karl fischer titrate is connected to the
system where the end point is detected
automatically by the system and the
results are observed on the monitor.
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 E. Dissolution apparatus:
 Dissolution is defined as the rate
at which the drug is released into
the systemic circulation from the
dosage form.
 It is the process of extracting the
API out of the dosage form solid-
state matrix into solution within
the gastro intestinal tract.
 For solid dosage forms, industry
standard dissolution testing
methods are the USP apparatus 1
and the USP apparatus 2.

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 F. Stability chamber:
 Stability of pharmaceutical products
may be defined as the capability of a
particular formulation in a specific
container to remain with its
physical, chemical, microbiological
therapeutic and toxicological
specifications.
 Stability testing is to provide
evidence on how the quality of a
drug substance varies with time
under the influence of a variety of
environmental factors such as
temperature, humidity, light etc.,

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 7. Quality Assurance:
 Quality Assurance is defined as “All the planned and systematic
activities implemented with in the quality system that can be
demonstrated to provide confidence that a product or service will fulfill
requirements for quality”.
 Quality Assurance is fundamentally focused on planning and
documenting those processes to assure quality including things such as
quality plans and inspection and test plans.
 Quality assurance is a system for evaluating performance, service of
the quality product against a system, standard or specified requirement
for customers.
 Establish a good quality management system and the assessment of its
adequacy & conformance audit of the operation system and review of
the system itself.

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 8. Pharmaceutical engineering:
 Pharmaceutical engineering is a branch of pharmaceutical science
and technology that involves development and manufacturing of
products, processes and components in the pharmaceutical industry
(i.e., drugs & biologics).
 In engineering department we mainly observe:
A. Mineral water plant.
B. Heating ventilation and air conditioning system.

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 A. Mineral water plant:
 Water is the most widely used
substance, raw material or
ingredient in the production.
Hence it must be purified.
Principle:
 The main principle involved in
this water plant is reverse
osmosis process in industry the
water plant model name is
Double pass reverse osmosis.

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 B. HVAC system:
 It consists of ,

 Heating systems

 Ventilation

 Air conditioning
systems

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HVAC:
Heating Systems:
 The most commonly used type of heating system is radiant heating
system.
 Heat is delivered to the various departments via radiators, radiant floor
system under floor piping.
Ventilation:
 All industrial areas need ventilation to maintain the quality and to
remove moisture and dust in air in all departments.
Air Conditioning:
 The air conditioners provide cooling and dehumidification by
transfering heat from inside the room to outside.

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 Warehousing
 Since warehousing is normally the largest operation in
the plant in terms of area, special attention should be focused on
maintaining cleanliness. The entire warehousing area should be
cleaned as often as necessary to maintain sanitary conditions.
There are three separate areas in ware house. They are:
 Raw material warehouse
 Packing material warehouse
 Finished goods warehouse

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 9. CONCLUSION:
From the Pharmaceutical industrial training of one month which
was carried out in NATCO Pharma company we acquire theoretical as
well as practical and industrial knowledge.
We observed various equipments, documentations included in the
R&D, Production, Quality control, Quality assurance and Engineering
departments in the NATCO Pharma industry.
In-plant training helped me to acquire knowledge on drug
manufacture and it will be very much useful in my professional life.

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 10. REFERENCES:
1. Formulation development services at UPM pharmaceuticals.
2.The art of High Shear Mixing by Charles Ross & Son Company.
3. Pharmaceutical engineering test book by C.V.S Subramanyam.
4. Capsule filling machine by the theory & practice of industrial pharmacy by
Lean Lachman & Herbert A.
5. Blister Packing by “Pharmaceutical equipment”, Apteka95.com.ua.
Retrieved
6. HPLC by Agilent technologies HPLC BASIS
7. GC by Linde AG. Retrieved 11 March 2012.
8. Disintegration by European Pharmacoepia 5.0
9.Fischer, Karl(1935) “Neues Verfahron zur mabanalytischen Bestimmung des
Wassergehaltes von Flussigkeiten und festen korpem” Angew. Chem.48(26).
10. U.S. FDA/CDEP, Guidance for industry, “Dissolution testing of
immediate release solid oral dosage forms” 1997.

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 11. Microboilogical Laboratory by Mahavira is dated 599 BC - 527 BC.
See. Dundas, Paul; John Hinnels ed. (2002). The Jain. London: Routledge
12. Stability by cvs subrahmanyam
13. Mineral Water Plant by LaMoreaux, Philip E.; Tanner, Judy T, eds. (2001), 
14. Heating, Ventillation and Air Conditioing systems by Dalin P., Rubenhag A.
(2006).

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 THANK YOU

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