Report

On
In- plant Training
Completed At
SYMBIOSIS PHARMACEUTICALS LIMITED ,
SANGLI.

Submitted By:
1. Miss . Neha V. Kurle
2. Miss. Anupama C. Jatakar

Annasaheb Dance College of B Pharmacy, Ashta,

Talk: Walwa, Dist: Sangli, Maharashtra.

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 DECLARATION

We hereby declare that the training report entitled “INDUSTRIAL TRAINING

REPORT- SYMBIOSIS CO-OPERATIVE PHARMACEUTICALS PVT. LTD.” has been

prepared by us under the guidance and supervision of our training and plavement
officer prof. Sandip M. Honmane Annasaheb Dance College of B Pharmacy,
Ashta, in partial fulfillment of the requirement for the award of the degree of
Bachelor of Pharmacy.
We further declare that we have not submitted this work previously.

Date: /07/2019 Miss . Neha Kurle

Miss. Anupama Jatakar
Place: Ashta

CERTIFICATE

This is to certify that the training report on “INDUSTRIAL TRAINING REPORT-

“SYMBIOSIS CO-OPERATIVE PHARMACEUTICALS PVT. LTD” submitted by Miss.

Neha V. Kurle & Anupama C. Jatakar in the partial fulfillment for the award of
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degree of Bachelor of Pharmacy, through Anmasaheb Dange College of Pharmacy,
Ashta. This training report is now ready for examination.

Dr. P. K. Pawar

Principal,
Annasaheb Dance,
College of Pharmacy,
Ashta

ACKNOWLEDGEMENT

It is precious moment to acknowledge the various individuals who helped me

during completion of this project.

Firstly, I would like to thanks my guide Mr.S. M. Honmane for his valuable
guidance, continuous encouragement during completion of project.

I am thankful to Dr. P. K. Pawar,, the principal of our college for this constant
encouragement.

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I am thankful to my family members who encourages and support me all time.

My heartful thanks to our librarian for providing me books and time to time
valuable help.

I am thankful to production manager Mr. D. D. Chowgule for his endurable and

constant guidance.I would like thank all my friends, colleagues, senior and juniors
for their Best Wishes.

Lastly, I thanks to Annasaheb Dange college of Pharmacy and well-wishers who

have contributed directly or indirectly for successful completion of this project.

Date: Miss. N.V.. Kurle & Miss. A.C..Jatakar

INDEX

Sr.No. Particulars Page No.

1 Company Profile and Organiasation

2 Departments
3 Air Handeling Unit
4 Water Purification Treatment Plant
5 Raw Material
6 Manufacturing
7 Quality Control
8 Utilities Available

9 Quality Assurance

4
10 List of Products

11 Traning Certificate

12 Conclusion

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 SYMBIOSIS CO-OPERATIVE
PHARMACEUTICAL.LTD.SANGLI

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 COMPANY PROFILE
Based in Sangli ( Maharashtra), Symbiosis Cooperative Pharmaceuticals Ltd. was incorporated
in the year 1994.The company is leading the road to success with visionary guidance and
optimistic approach of Mr. D. D Chougule (Chairman) and consistent support of professional
board of Directors . State of the art infrastructure we own systematically managed infrastructure
well segregated in different departments namely office ,manufacturing, quality assurance,B.S.R.
and raw material storage and managedby team of trained,experienced and technically competent
professionals. The total area of the company comprises of about 6690 square meter whereas, the
built up area is 2396.3 square meter. Further, overall manufacturing activity is carried out as per
the standard procedures directed by GMP. Compliances with Regulatory considerations. The
Companys quality policy states : “We Symbiosis Co-Op. Pharmaceuticals Ltd. As a collectively
adhered to ensure and assure that the every product manufactured and distributed to our end meet
with the current standards of quality, purity, efficacy and safety soas to satisfy all the
requirements of our customers and end users”

ADDRESS: SYMBIOSIS CO-OP.PHARMACEUTICALS LTD.

Plot no. J-89,MIDC, Kupwad Block Sangli-416416

ORGANISATION OF COMPANY

DEPARTMENTS

 Personnel
 Store
 Quality assurance
 Production

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  Quality control
 Packaging
 Sales and Marketing
 Regulatory Affairs
 Maintenance

AIR HANDELING UNIT (AHU)

It has 4 classes :

Class A – 100’s/cu.ft

Class B -10000’s/cu.ft

Class C – 1000000’s/ cu.ft.

Fresh air 80%-90% - 5 microns-10 microns.

Planum – 5 microns-3 microns

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HEPA filters – (0.33 microns) DOP (dioctyle Phthalate) cleaned every month –particulate matter
test-sampling-microbial study i.e 5 days- microbes-7 days-pathogens.

PURIFIED WATER TREATMENT PLANT

First of all M.I.D.C portable water comes and in 3000litre 2 tanks.

Then it goes to the sand filter using 3HP pump. Back wash is too given in this sand filter tank.

Water passes to 20000 overhead water storage tank

By using 1.5 HP pump water is then passed ultra filter plant.

It has 20 micron filter.- where prefilteration is done.

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These three filter can be cleaned by 10%HCL, 2% NaoH, 2%NaOCL.

The filtered water is stored in 3000 litre storage tank.

It is cleaned weakly with 0.01% Tipol solution.

By using Hp pump it is passed to reverse osmosis plant.

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 RAW MATERIALS

Raw materials and packaging material:

The receipt of each Raw and Packaging Material is intimated by security.

After receipt of the intimation of the consignment each document should be examined carefully

Check Delivery Challan (Whether the material is received as per Purchase order, whether the
material received from approved vendors.)

Before unloading inspect the vehicle for cleanliness.

Each delivered of raw and packaging material should be examined visually while unloading.

Match information on outer shipper or packs as mentioned in delivery challan.

If material received is damaged breakage or leakage or not in intact condition, such container is
to be segregated from other materials and kept aside with a suitable manner.

Each container ,bags and packets should be cleaned from outside by vaccum cleaner and dry lint
free cloth in receiving bay.

At the time of unloading Raw or packing material it should be crossed verified with invoice or
delivery challan and must checked physically for the the following points for its correctness;

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  Name of Material
 Quantity per packet or container
 Mfg. Date/Expiry date. Use before date
 Batch NO.
 Net. weight, Gross weight, Tare weight.
 Storage condition on packs

After de-dusting store person shall shift the material in staging area for physical verification.

Record the observations in physical verification record.

Deface the approved label of the manufacturer on the container, with a black marker pen.

Transfer material to quarantine area.

Give the acknowledgement to the transporter. Record all the details in material inward register.

Fix the QARANTINE label on each and every container for all Raw material and ensure that
manufacturer label or name of the product should not be covered by the quarantine label.

After sampling, Q.C dept shall put sticker as “SAMPLED”adjacent on quarantine labels of
sampled containers.

After completion of analysis Q.C person will affix the “APPROVED” or “REJECTED” label on
the quarantine label.

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 Tranfer the material to respective stores after Q.C analysis. ( Green label)

Transfer the material in designated approved storage area.if rejected by Q.C dept. (RED
label )

All raw materials should be stored on racks.

MANUFACTURING

20 Microns and 1 Microns . Filter are used in boiler for portable water.

Rinsed with purified water

Check all the equipments

Manufacturing starts after all inspection.

Prepare sugar syrup. ( By using pharmagrade sugar.)

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Then filter from 200 mesh filter.

Micro testing is done .

Sugar content is checked by polarimeter.

Above or below 5% is allowed.

Drug slurry is prepared.

Filter it and add in syrup.

Check pH and add sweetening agent.

Add colouring agent.

Finally make up the volume .

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Bulk testing is done.

Clarity is checked.

Labelling is done

Label is checked.

Leak test is done.

Packaging.

 STEPS INVOLVES IN MANUFACTURING

 Material are weighed as per work order in presence of supervisor and brought to
manufacturing area.
 Before starting of operation, cleaning of tank is checked.
 The weighed materials are poured in stainless steel tanks.
 The liquid is clarified by cycling through the filtration system. The material is
collected in another tank until released from Q.C. department. A label under test is
attached.
 Once the Q.C. approves the formulation then the bottles are filled, sealed and then put
in inspection unit. There it is checked for clarity and presence of any defects to the
bottle during the filling of the bottles, they are passing from the magnifying system
for checking of any cuts or breaks of bottles.
 A record of filling is maintained.

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Figure 1. Top view of bulk liquid manufacturing tank

Figure 2. Rotary bottle filling machine

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 QUALITY CONTROL

In this department first water testing is done for checking whether its potable or purified
one .
Following tests are done for water testing.
 pH: 100ml H2O+0.3ml saturated solution of KCL
 Hardness
 Total dissolved solids
 Acidity or Akalinity
 Ammonia
 Calcium and Magnesium
 Heavy Metals
 Chloride

List of documents maintained on QC:

1. Raw material specification

2. Packaging material specification
3. Label/carton colour shade card
4. Finished product specification

QC maintains the specification for raw materials,packaging material, bulk product, and finished
product. Inspect , analyse.

Quality Control is one of the key departments in any Pharma company. After R&D large
number of people works in the QC department.

A chemist executing a qualitative analysis seeks to identify the substances in the sample. A
quantitative analysis is an attempt to determine the quantity or concentration of a specific
substance in the sample. For example, determining whether a sample of salt contains the

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element iodine is a qualitative analysis; measuring the percentage by weight of any iodine in
the sample is a quantitative analysis

Functions of quality control department

 To carries official tests of raw materials.

 To performs official tests of manufactured product during process & finishedones.
 To checks process &equipments during production.
 To checks area of production for cleanliness.
 Checks of packaging materials & also printed labels.
 To issue pass or rejection labels for raw materials & packing materials.
 To checks of stored & finished product after a specified time.
 Maintenance of records of all assay & test performed in Q.C. department.
 Quality Control had two different divisions
1. Weight Analysis
2. Instrumental Analysis

The different Instruments used in QC department are:

 UPLCFTIR
 KF Titration
 HPLC Particle size analyzer
 Melting Point apparatus
 GCXRD Polarimeter
 Friability Apparatus
 Disintegration Apparatus TLC

Once the raw material enters the factory premises and before going to the Stores department
the Quality of the material will be checked by QC department. If the quality is as per the
guidelines then the QC department approves the raw material. This is called Raw material
analysis. The concerned QC chemist will perform the basic duties and the Group leader or
Manager approves. Finished Product analysis will be done after the Product/material is

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 manufactured.

UTILITIES AVAILABLE

a. Boiler
b. Generator
c. Air compressor
d. Cooling tower
e. Air handeling unit
f. Hoist no.1 &2
g. Dust collector
h. Split A.C
i. Vacuum Desicators
j. Air curtains

1. U.V. Spectrophotometer

Figure 1. U.V. Spectrophpotometer

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 Hardware features
 Compact design.
 Resolution to less than 2nm.
 High mass, stable optical bench.
 Wide dynamic range.
 Ultra small beam…1mm.
 Double beam optical system.
 Range from 190 to 1100 mm.

2. Polarimeter

Specifications
Scales:
Angular 0.3600 subdivided to 10 micrometer drum enable direct reading to 0.50
and by estimation to 0.20.

SOURCE
Sodium lamp 35 watts. White light can be up to 120.

RANGE OF THIS SCALE

+30 to -130.
The Quality will be checked in three different stages.
1) Raw material analysis
2) In Process Sample analysis
3) Finished Product analysis

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 Figure 2. Polarimeter

STANDARD OPERATING PROCEDURE

 Switch on the instruments.
 Focus the top eyepiece to show scale & index line.
 Observe through the scale telescope.
 Turn the control wheel until the scale reads ‘ZERO’ on the upper scale.
 Now observe through field telescope & focus to get circular disc of light.
 By the means of control wheel, bring ‘Two’ halves of circular disc of equalintensity.
 Note the reading through the scale telescope.
 Switch off the POWER SWITCH of the instrument & disconnect from AC mains.

Precautions
 With no sample in through, micrometer drum & scale in telescope should be zero.
 Before turning power on check that stabilizer is connected to the instrument.

3. Digital PH Meter

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 Figure 3. Digital PHMeter

FEATURES
 Accurate and highly stable
 Automatic, temperature compensation and manual slope correction
 Elegantly styled
 Small laboratory version
 Output for recording version
 Usable for potentiometric titration, redox potential & ion selective
electrodemeasurement

SPECIFICATIONS
1- pH
 Range : 0-14
 Resolution : 0.01
 Accuracy : ± 0.01
 Repeatability : ± 0.01
 Stability: ± 0.05 in 8 Hr.

2- Emf in mV
 Range: 0 - ±1999
 Resolution : ± 0.01
 Accuracy : ± 0.01% of or ±2

3-Input
 Receptacles : BNC

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 Polarizing currents : 10u A
 Isopotential point : 700
 Slope correction : 80-105%
 Temp. compensation : 0-100°C

STANDARD OPERATING PROCEDURE

 Connect the instrument to mains and allow warming up for about 10 min.
 Prepare 3 buffer solutions of pH 9.2, 4, 7 using standard buffers in distilled water.
 Adjust temp. dial to the temp. of solution also put mode switch in pH position.
 Dip the electrode fully in 7 pH solution and wait for reading stabilized. Adjust
theASYMMPOT. Knob to get reading of 7.
 Now immerse the electrode in either pH 9.2 or pH 4 buffers and adjust the slopeknob
so that display reads pH of buffer and tighten the nut.
 Repeat step 4 & 5 again, each time electrodes are to be washed in distilled water.
 To check immerse the electrode in third buffer to verify.

4. Broookfield Viscometer

Features and Benefits

 Continues torque sensing capability.
 Torque measurement accuracy : 1% of full scale range
 Repeatability: 0.2 % full scale range.
 Easy speed adjustment and on/off control.
 Compatible with all Brookfield accessories.
 NIST traceable viscosity standard available.
 Electronic drive means quiet, reliable operation.
 Universal power supply worldwide compatibility.
 2 years limited warranty.
 Traditional Brookfield quail.

Figure 4. Brookfield viscometer

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 5. Karl Fischer Titration

Figure 5. Karl Fischer titration

Features

 Dispensing pump for Un-interrupted and convenient operation. Instrument

withmicrocontroller, self explanatory alphanumeric display.
 Automatic calculation of moisture control, PPM and %
 The instrument is designed for accurate estimation of moisture in various solid,liquid or
gas samples. It is used by QC and R&D laboratories. The instrument isalso suitable for
accurate estimation of moisture in transformation / insulation oiletc.

6. Laboratory Vaccum Oven

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 Figure 10. Vaccum Oven

FEATURES
 All stainless steel chambers.
 Low leakage rate.
 High reliability.
 Resistance to corrosive atmosphere.
 Full view of interior
 Insulated with glass wool / water jacket / both.

QUALITY ASSURANCE

Quality assurance department prepares following documents with the help of concerned
personnel of every section.

 Validation documents
 Standard Operating Procedures

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The documents are- Installation qualification, operational qualification and performance
qualification for process equipments and critical instruments.

Quality Assurance ensures that all the activities and process parameters are strictly followed as
per Standard Operating Procedures and process instructons.

Every incoming material is tested before use for production and in process checks are done
during production activity at specific stages. The test methods, equipments and manufacturing
process are validated.

All the production activities are carried out under the supervision of expert technical staff. The
senior personeel give training to all employees as per schedule and monitor the periodic
assessment of the training.Every personnel from the production department are committed to
achieve budgeted production within the specified yields and quality standards.

“Quality is never an accident, it is always the result of high intension,

sincereeffort, intelligent direction and skillful execution, it represents the wise
choice of many alternatives”

Principle:Q.A. is a wide ranging concept covering all matters that individually orcollectively
influence the quality of a product. It is the totality of the arrangements made With the object
of ensuring that pharmaceutical products are of the quality required for the intended use. Q.A.
therefore incorporates GMP and other factors, including those outside the scope such as
product design and development.

 The system of Q.A. appropriate to the manufacturing of pharmaceutical productsshould

ensure that:
 Production and control operations are clearly specified in a written form andGMP

Functions:

Functions of quality assurance department are to see that;

 Pharmaceutical products are designed and developed in a way that takesaccount of

requirements of GMP and other associated codes such as those ofgood laboratory
practice (GLP) and good clinical practice (GCP).

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 Production and control are clearly specified in a written form and GMPrequirements
are adopted.
 Managerial responsibilities are clearly specified in job descriptions;
 Arrangements are made for the manufacture, supply, and use of the correctstarting and
packaging materials.
 All necessary controls on starting materials, intermediate products, and bulkproducts
and other in-process controls, calibrations, and validations are carriedout.
 The finished product is correctly processed and checked, according to thedefined
procedures.
 Pharmaceutical products are not sold or supplied before the authorized personshave
certified that each production batch has been produced and controlled inaccordance
with the; requirements of the marketing authorization and anyother regulations relevant
to the production, control and release ofpharmaceutical products.
 Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical
products are stored by the manufacturer, distributed, and
Subsequently handled so that quality is maintained throughout their shelf life.
Quality assurance is a wide-ranging concept covering all matters that individually or
collectively influence the quality of product. It is the totality of arrangements made
with the object of ensuring that pharmaceutical products are of the quality required for
their intended use. Quality assurance therefore incorporates GMP and other factors,
including those outside the scope of this guide such as product design and development

GMP for Pharmaceutical Products:

Good manufacturing practice is that part of quality assurance which ensuresthat
products are consistently produced and controlled to the quality standards appropriate
to their intended use and as required by the marketing authorization. GMP rules are
directed primarily to diminishing the risks, inherent in any pharmaceutical production,
which cannot be prevented completely through the testing of final products. Such risks
are essentially of two types: cross-contamination (in particular by unexpected

27
 contaminants) and mix-ups (confusion) caused by false labels being put on containers.
Under GMP:

 All manufacturing processes are clearly defined, systematically reviewed in thein the
light of experience, and shown to be capable of consistentlymanufacturing
pharmaceutical products of the required quality that comply withtheir specifications;
 Critical steps of manufacturing processes and any significant changes made tothe
processes are validated;
 All necessary facilities are provided, including:
 Instructions and procedures are written in clear and unambiguous language,specifically
applicable to the facilities provided.
 Operators are trained to carry out procedures correctly.
 Records are made (manually and/or by recording instruments) duringmanufacture to
show that all the steps required by the defined procedures andinstructions have in fact
been taken and that the quantity and quality of theproduct are as expected; any
significant deviations are fully recorded andinvestigated.
 Records covering manufacture and distribution, which enable the completehistory of a
batch to be traced, are retained in a comprehensible and accessibleform.
 The proper storage and distribution of the products minimizes any risk to theirquality

LIST OF PRODUCTS

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1) Alreid Syrup 30ml/60ml

2) Mebex Suspension 30ml

3) Bendex Suspension 10ml
4) Colimax OF+ Drops 15ml
5) Flucold AF Drops
6) Colimax Drops

7) Cheston CS Suspension (Export )

8) Dimol Drops

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 Conclusion

The industrial training is very important for pharmacy students. It is also a good apportunity to
aquire a practical knowledge. During my training , I acquired a lot of new things. That will be
help to clarify my theoretical knowledge. I hope and pray that it will help me much ,ore in my
future profession.

During our training time i had seen various instruments and apparatus and system. We could
acquire lot of information regarding this instrument and their working procedure.

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