Akums Drugs & Pharmaceuticals

Ltd.
Vocational Summer
Training carried out in :-

PLANT -3 Injectables,
SVP, LVP, Ear & Eye
drops

Q.C. Department
Submitted by:-

Rishabh Dobriyal
B.Pharm 4th yr.
Roll No:- 110480300022
Duration of training:30.06.2014 to 30.07.2014

Dev Bhoomi Institute of Pharmacy & Research

COMPANY PROFILE
Akums Drugs & Pharmaceuticals Ltd, Haridwar, (India), is an
internationally recognized WHO-GMP certified and one of the leading
contract manufacturing and has rapidly emerged as the premier
integrated pharmaceutical company in India. Its business focuses on
the manufacture and marketing of pharmaceutical products and
services to clients across the globe, portfolio includes a range of USFDA norms producingHORMONALpreparations inOral(Solid &
Liquid)& Injectableforms,Skin Ointments &
Cosmeticpreparations,Oncologyformulations and Contract
Research and Manufacturing Services.

The company is one of the largest manufacturers and sixstate-ofthe-artmanuafacturing facilities have huge per day capacity to
produce formulations in practically all dosage forms, i.e. Tablets,
Capsules, Soft Gels, Dry Syrups, Liquid Orals, Powder in Sachet, Dry
& Liquid Injections, Pre-filled Syringes, Large Volume Parenterals (up
to 100 ml) and Eye / Ear / Nasal Drops inForm Fill & Seal and
Three PiecePacks. Over the years,AkumsDrugs &
Pharmaceuticals Ltd has established a global footprint in fulfilling the

Message from
COMPANY:AtAkums,
we believe that if we take care of the present,

we inspire a better future. It is this vision towards a

disease-free world, a sustainable natural environment and
a healthy global population, that supports our commitment
to ensure the highest quality of products and services
towards offering un-parallel care to our clients and to the
larger community. The company currently supports a
personnel base of more than 5500 employees in locations
across India and has expanded its network of overseas
offices. Set up a Research and Development Centre to
Further strengthen its position as one of the leading
exporters of pharmaceutical products.

Plant 1
Started in 2004 and the foundation
ofAkums, Plant 1 is dedicated to
manufacture Oral Solid Dosage Forms

Plant 2
Started in 2007,AkumsPlant-2,
dedicated in Liquid Orals offers
manufacturing of Syrups,
Suspensions, Drops, and Jellies.

ass

Plant 3
With full dedication in Injectables,
Plant-3 offers manufacturing of Prefilled Syringes, Liquid and Dry InjectionVials/Ampoules, Penicillin,
Eye/Ear/Nasal Drops, Lyophilized
Injections and many more.

Plant 4
Concentrated in Hormonal
Preparations,AkumsPlant-4 came into
existence in 2010, offering facilities in
Tablets, Hard/Soft Gelatin Capsules,
Liquid Orals and Injectables in
Vials/Ampoules.

Plant 5
A dedicated Plant for Ointments
& Cosmetics,AkumsPlant-5
offers manufacturing of Creams,
Gels/ Tonics, Scrubs/ Lotions,
Non-medicated Toothpaste,
Shampoos/StylingGels, Oils and
many more . Started in 2010, it
is concentrated in Dermatology
and Cosmetics.

Plant 6
Maxcure
AkumsPlant-6, Maxcure, a
100% subsidiary of Akums
Drugs & Pharmaceuticals Ltd
e
setup
in 2010, manufactures
Ayurvedic, Nutraceutical &
Food supplements for top
Pharma companies of India.

FACILITIES & INFRASTRUCTURE

Brief Description of Critical Areas:
1. Receiving Bay: This area is meant for unloading & preliminary
inspection of the incoming material.
2. Sampling Unit & Dispensing Unit: These areas are developed
for sampling for incoming raw material & for dispensing of raw
material to the production areas. Each area has reverse laminar air
flow having 5 micron filter at delivery point and a prefilter of 10
micron at the entry from where fresh air is drawn.
3. Under test raw material store: Developed to retain the
received raw material till its analysis from Q.C. Department.
4. Approved R.M. Store: The area is meant for storage of approved
R.M. after analysis by Q.C. It has one air conditioned sub store for
storage of thermo liable items.
5. Rejected R.M. Store: A separate area for the raw material found
rejected by Q.C. as per the laid down specification is developed for
storage and further preceding thereafter.

PLANT : 3
Injectables, SVP, LVP, Ear & Eye
drops

Introduction to
Q.C. Department

Quality Control laboratories are fully inspected by the

MHRA and FDA. All Quality Control activities and
equipment are fully supported by approved GMP
documentation.
The services offered by our Quality Control Group include:
In-process, bulk and finished drug product
(packaged) testing
Drug product stability testing
Testing of equipment for absence of drug
substance and detergent (cleaning verification)
Microbial testing of drug products (stability and
bioburden)
Method transfer

Containers for
parenteral

An ampoule (also
ampul, ampule, or
ampulla) is a small
sealed vial which is
used to contain and
preserve a sample,
usually a solid or
liquid

A vial (also known as

a phial or flacon) is a small
glass or plastic vessel or
bottle, often used to store
medication as liquids,
powders orcapsules.
screw vials (closed with a
screw cap or dropper /
pipette), lip vials (closed
with a cork or plastic stopper
) and crimp vials (closed
with a rubber stopper and a
metal cap).

BASIC INSTRUMENTS:1. Vernier Caliper: Vernier Caliper is used to measure

the dimensions of Ampoule, rubber bung, vials.

2. Weighing Balance

pH meters: pH is the negative logarithm

of hydrogen ion concentration. Every
substance has its specific pH range. So pH
meter is used for identification of pH range of
the substance.

Conductivity meter:
An electrical conductivity
meter (EC meter) measures the
electrical conductivity in a solution.

ULTRASONIC
BATH

Sonication is the act of

applying sound energy to
agitate particles in a sample,
for various purposes.
Ultrasonic frequencies
(>20 kHz) are usually used,
leading to the process also
being known
as ultrasonication or ultrasonication.[1]
In the laboratory, it is usually
applied using an ultrasonic
bath or an ultrasonic probe,
colloquially known as
a sonicator.

Karl Fischer titration is a

classic titration method in analytical
chemistry that uses coulometric
or volumetric titration to determine
trace amounts of water in a sample.
It was invented in 1935 by the
German chemist Karl Fischer

WATER FOR INJECTION:PREPARATION OF WFI

BORE WELL
WATER

RAW WATER
(pH-6 to 8)
Sodium
metabisulphate
dosing
PASSING
THROUGH SAND
FILTER

SODIUM
HYPOCHLORIDE
SOFT WATER
(pH-6 to 8)

ULTRA
FILTERATION
TANK

RO 2
CEPHALOSPORIN
BLOCK
PENICILLIN
BLOCK

RO 1
RO 2
LIQUID
INJECTION

UV PASS
(Microbes
removed)

EDI
(Electrode
Deionisation)

DEMINERALISATION

PW
TANK

BOILER
At 143c

MULTIPLE COLOUMN
DISTILLATION PLANT

Gas Chromatography

Basic Principle of GC sample

vaporized by injection into a
heated system, eluted through
a column by inert gaseous mobile
phase and detected

INTRODUCTION

The key parts of a gas chromatograph include:

a source of gas as the mobile phase
an inlet to deliver sample to
a column, the column where separations occur
an oven as a thermostat for the column
a detector to register the presence of a chemical in the
column effluent
a data system to record and display the chromatogram.

Flowchart for GC:-

COLOUMNS

Packed columns are 1.5 - 10 m in length and have an

internal diameter of 2 - 4 mm. The tubing is usually
made of stainless steel or glass and contains a packing
of finely divided, inert, solid support material that is
coated with a liquid or solid stationary phase.
Capillary columns have a very small internal
diameter, on the order of a few tenths of millimeters,
and lengths between 25-60 meters are common.

DETECTORS

Flame Ionization
Detector (FID)
Thermal Conductivity
Detector (TCD)
Electron Capture Detector
Thermionic Detector
Flame Photometric Detector (FPD)
Photoionization Detector (PID)

HPLC

HPLC is an abbreviation for High Performance

Liquid Chromatography(It has also been
referred to as High Pressure LC)

HPLC is a separation technique that involves:

the injection of a small volume of liquid sample
into a tube packed with tiny particles (3 to 5 micron (m) in
diameter called the stationary phase)
where individual components of the sample are moved down the
packed tube (column) with a liquid (mobile phase) forced through
the column by high pressure delivered by a pump
These components are separatedfrom one another by the
column packing that involves various chemical and/or physical
interactions between their molecules and the packing particles.
These separated components are detected at the exit of this tube
(column) by a flow-through device (detector) that measures their
amount.

FLOWCHART FOR HPLC

COMPONENTS OF HPLC
Describing the 5 major HPLC components and their functions
1. Pump:
The role of the pump is to force a liquid (called the mobile phase) through
the liquid chromatograph at a specific flow rate, expressed in milliliters per
min (mL/min).
Normal flow rates in HPLC are in the 1-to 2-mL/min range.
Typical pumps can reach pressures in the range of 6000-9000 psi (400-to
600-bar).
During the chromatographic experiment, a pump can deliver a constant
mobile phase composition (isocratic) or an increasing mobile phase
composition (gradient).
2. Injector:
The injector serves to introduce the liquid sample into the flow stream of
the mobile phase.
Typical sample volumes are 5-to 20-microliters (L).
The injector must also be able to withstand the high pressures of the liquid
system.
An auto sampler is the automatic version for when the user has many
samples to analyze or when manual injection is not practical.

3. Column:

Considered the heart of the chromatograph the columns stationary phase

separates the sample components of interest using various physical and
chemical parameters.
The small particles inside the column are what
cause the high back pressure at normal flow rates.
The pump must push hard to move the mobile
phase through the column and this resistance causes
a high pressure within the chromatograph.

4. Detector:

The detector can see (detect) the individual

molecules that come out (elute) from the column.
A detector serves to measure the amount of those molecules so that the
chemist can quantitatively analyze the sample components.
The detector provides an output to a recorder or computer that results in
the liquid chromatogram(i.e., the graph of the detector response).

5. Computer:

Frequently called the data system, the computer not only controls all the
modules of the HPLC instrument but it takes the signal from the detector and
uses it to determine the time of elution (retention time) of the sample
components (qualitative analysis) and the amount of sample (quantitative
analysis).

MOBILE PHASE
Depending upon polarity(Increasing
order):-

N-Hexane
Methylene chloride
Chloroform
Methyl-t-butyl ether
Tetrahydrofuran (THF)
Isopropanol
Acetonitrile
Methanol
Water

Detectors

UV Detector
Fluorescence
Refractive Index
Electrochemical
Conductivity

What is HPLC
used for?
Qualitative analysis
the most common parameter for compound ID is its retention time(the time
it takes for that specific compound to elute from the column after injection)

Quantitative Analysis
The measurement of the amount of a compound in a sample
(concentration); meaning, how much is there?;
There are two main ways to interpret a chromatogram(i.e. perform
quantification):
1.determination of the peak height of a chromatographic peak as measured
from the baseline;
2.determination of the peak area (see figure below);

FT-IR?
FT-IR stands for Fourier Transform Infrared, the preferred method of
infrared spectroscopy.
In infrared spectroscopy, IR radiation is passed through a sample. Some of
the infrared radiation is absorbed by the sample and some of it is passed
through (transmitted).
The resulting spectrum represents the molecular absorption and
transmission, creating a molecular fingerprint of the sample.

UV spectrophotometry

Ultravioletvisible spectroscopy or ultraviolet-visible

spectrophotometry (UV-Vis or UV/Vis) refers to absorption
spectroscopy or reflectance spectroscopy in the ultraviolet-visible spectral
region. This means it uses light in the visible and adjacent (near-UV
and near-infrared [NIR]) ranges. The absorption or reflectance in the visible
range directly affects the perceived color of the chemicals involved. In this
region of the electromagnetic spectrum, molecules undergo electronic
transitions.

PACKAGING:3. Bursting strength test apparatus: The force required for

bursting or complete rupture of the board is measured through
a Digital Indicator. The bursting strength defines the materials
quality as compared to the others. Digital
Bursting Strength Tester provides
a hydraulic load under a rubber diaphragm
of a specific area of the sample under test. It
can be used to accurately determine the
bursting strength of paper, corrugated
cardboard, carton box, card board, leather,
cloth or synthetic leathers. The bursting
strength value is expressed in terms of
kgs/cm2.

Pharmaceutical
Tablets
PRODUCTS
We hold expertise in successfully offering in the
Indian markets around forty different types of
pharmaceutical tablets that are carefully formulated
to fight diseases as well as keep people healthy.
These tablets are made available in tamper proof
packaging so as to provide in these longer shelf life.
Pharmaceutical Capsules
We offer extensive research based Pharmaceutical
Capsules that are highly effective as well as accurate
in composition. Safe to consume, these Capsules are
offered by us in appropriate packaging so as to
maintain their properties for a long period of time. Its
tamper proof packaging also ensures these remain
safe as well as deliver higher shelf life.
Soft Gelatin Capsules
We offer Soft Gelatin Capsules for meeting the
treatment needs of various ailments. These Soft
gelatin capsules consist of filling that contain
dissolved/suspected active substance, and of a onepiece shell. Owing to the hermetic seal, filling
ingredients are protected against any harmful

Dry Syrups
We also hold expertise in the manufacturing of Dry
Powder Syrups. These are very useful in meeting the
successful treatment needs of various ailments. These
syrups can be orally consumed and are clinically tested so
as to ensure these have no side effects.
Prefilled Syringes
We are engaged in meeting the manufacturing demands
of Prefilled syringes. With the rapid rise in technology in
the medical field, these needles are designed to cater to
the needs of ill people. We offer these in tamper proof
quality packaging so as to ensure their safety as well as
longer shelf life.
Hormonal Preparations
Recognized by W.H.O G.M.P and 14001:2004
specifications,Akums specialize in producing and
distributing hormonal preparations. Our company holds
GMP plant and top-ranking pharmaceutical equipment
offering the best quality preparations and serving
healthier future of brightness to the world.
Eye & Ear Drops
We hold expertise in offering Eye, Ear, Nasal Drops in FFS
& 3-pc Packs. A result of continuous R&D done at our unit,
these drops manufactured by us are carefully formulated
and used for curing eye as well as other infections/
related ailments. Our expertise lies in offering these in

Liquid Orals
We offer high range of oral liquid section, which caters
to the needs of the pharmaceutical industry. The
dosage is formulated using high quality ingredients
and technologically advanced machines. Our range is
highly effective and renders good results and being
the packing done in safe and hygienic conditions it
ensures high effective and enhanced shelf life.
Creams & Ointments
We offer customers Creams & Ointments that help in
providing velvety smooth texture that improves skin
firmness, elasticity, minimizes wrinkles as well as
tightens the skin. Featuring a perfect blend of skin
conditioning natural oil, vitamins & essential nutrients,
these ointments helps in reducing as well as in
preventing fine and expression lines.
Ayurvedic Products
We are manufacturing the Traditional medicines in the
traditional way of processing. The company has
played a pioneering role in re-establishing ancient
knowledge with modern research and manufacturing
techniques. And provide its gentle healing touch to
millions in the world. We constructed & follow-up
W.H.O G.M.P specifications. The processing & Packing

ASSOCIATE PARTNERS
SOME OF AKUMS VALUABLE CUSTOMERS

MARKETED PRODUCTS