IN PLANT TRAINING

REPORT
Name - Jitendra Umesh Vishwakarma.
L.Y.B.PHARM
Rollno - B79422
Company name - ACG capsules
 Date: 30th May 2022, Monday
Activity Done/observed References/discussion
Meeting with HR ● Discussed the role,
responsibilities, and
scope of the Internship
● Employee registration
Safety Induction Discussion about near miss
Program with Mr. incidents, injuries, precautions
Nagendra to avoid accidents including-
● Use of Personal
Protective Equipment
● Reporting of any accidents
● Briefing about fire
safety protocols
● Detailed information about
the assembly points and
plant layout
Quality ● Detailed study of Standard
Control Operating Procedure (SOP)
Department of Purified water, Gelatin,
Sampling and Plant
Handling
● Performed Purified water
Trend analysis performed
to study and report any
deviations.
● Performed the pH,
isoelectric pH and
conductivity testing on
Purified water
Lessons learnt
Information and history of the Company
Introduction to company's policies
and detailing.
Safety protocols to be strictly adhered
to in the plant premises
● On studying the SOP thoroughly, we
gained clarity about the appropriate
methodical approach towards testing
of Gelatin, Purified water and
Sampling and Plant Handling.
● Gained insight over importance
of Documentation in a
pharmaceutical Industry
● Performed the pH test and
conductivity test on Water samples
obtained from Gelatin Room, Return
Gelatin Loop, Return Hall 1, Return
Hall 2. While performing Isoelectric
pH, we used Resin in order to reduce
the pH to a
certain extent.
 Date:31st May2022,Tuesday

Activity References/discussion Lessons learnt

Done/observed
Meeting with Mr. ●Attended a Good Manufacturing ● Following GDP and
Chandan Kumar, Practices and Good GMP Protocol and
GMP Plant Head Documentation Practices correct Documentation
Workshop headed by Mr. Practices is of utmost
Chandan Kumar importance in
Pharmaceutical Industry
●Covered the GMP Protocol and
Guidelines, including appropriate use
of PPE kits, maintenance of personal
hygiene

●Covered GDP protocol, in which no

overwriting must be done on official
documents, logbooks etc. The result
obtained must be presented without
any data integrity.

●Wrong entries must be corrected by

adding an asterisk, cancelling the
wrong entry, and mentioning “Wrong
entry corrected” followed by
signature and date.

●No void spaces must be left blank,

they should always be marked with a
forward slash.
Quality ● Observed and received hands-on ● Understood the working
Control training on the use and working of of UV
Department UV spectrophotometer and spectrophotometer and
understood the absorbance appropriate placements
calculation and measurement using of cuvettes.
“ThermoInsight” program ● Understood the
● Performed Volumetric Analysis, importance of
titration and Standardization of performing tests on
Sodium Hydroxide using packaging materials and
Potassium Hydrogen Phthalate. labels.
● Performed the pH, isoelectric pH Eg- Static test is done to
and conductivity testing on Purified avoid or check for any
water. remaining foreign
● Prepared Ammonia Solution capsule or material in
and Ammonia Buffer the plastic bags which
can cause serious issues
when sent to
the customer.
 ● Complete Testing of packaging
material including corrugated
boxes, labels, and plastic bags
1. Test for plastic bags included
primary inspection for any
tears, static test, seal
measurement, dimensions etc.
2. Test for label included-
calculating the % gumming in
the respective layers as well as
the total label.
● Documentation of Loss on Drying
readings of Hard-shell Gelatin
Capsules following the GDP
protocol
● Studied the Indian Pharmacopoeia
for Trisodium Phosphate and
Tetrasodium Pyrophosphate

Date: 1st June 2022, Wednesday

Activity References/discussion Lessons learnt

Done/observed
Quality ● Detailed activity related to
Control Inventory Management of
Department chemicals (liquid and solid),
reagents, indicators, chemical
stock, and glassware stock.
● Online entry regarding the stock
and tabulating the list of
chemicals and
glassware available.
● First-in-First-Out and First-
Expired-First-Out is strictly
adhered to, in order to avoid
any chemical
incompatibilities and health
hazards.
 Date:2ndJ u ne 2022,Thursday
Activity References/discussion
Done/observed
Quality ● Performed the appropriate dilution
Control of various pigment samples for
Department measuring the absorbance.
● Operated the UV
spectrophotometer and calculated
the absorbance using
“ThermoInsight” program and
completing its necessary
documentation.
● Established the interference/ non-
interference of preservatives
(methyl paraben and propyl
paraben) in Gelatin capsules by
appropriate dilution in 50ml
Methanol and further calculation of
absorbance using UV
spectrophotometer.
● Performed the tests of pH,
Identification, Chloride content
and solubility (ether, water,
chloroform and ethanol) on
Silicon dioxide sample
● Performed Hardness (Titration
using EDTA) and chloride content
test (using test kit) on Purified water
sample
Lessons learnt
● It is necessary to understand
the presence and interference
of preservative content in the
capsule, as if these levels go
above the allowed limits, it
can cause a health hazard
● The dilution of the obtained
pigment samples is done, as
these colorants will give a
very high absorbance reading
at the necessary wavelength.
Once these dilutions and
calculations are performed,
the QC department then
releases its recommendations
(increase/decrease in amount
of colorant/water) to obtain
the necessary pigment.
 Date:3rdJ u n e 2022,Friday
Activity References/discussion Lessons learnt
Done/observed
Quality ● Performed the Assay and Loss on ● Performed the pilot test
Control ignition test of Silicon dioxide for Quantitative analysis
Department sample measurement of Ink
● Performed Non-volatile and Content.
Aldehyde and Ketone test on ● Learnt the importance of IPA
Isopropyl Alcohol Sample. in capsule manufacturing
● Performed pH, isoelectric pH, process.
and conductivity test of Gelatin
Sample.
● Performed Quantitative Analysis of
Ink Content per capsule (using n-
butanol and 100 capsules in RBF,
followed by filtration through G4
sintered glass filter. Then on
comparing the before and after
weights of G4 filter we get the
amount of solid ink content present
in a
printed capsule)

Date: 4th June 2022, Saturday

Activity References/discussion Lessons learnt

Done/observed
Quality ● Performed complete testing of Understood the properties,
Control Gelatin Samples. Tests included- limits, quality, and importance
Department 1. Solubility of testing the Gelatin Sample.
2. Appearance
3. Identification
4. Acidity
5. Aldehyde and ketones
6. Viscosity
7. Bloom strength
8. Gelling property
9. Residue on ignition
10. Sulphur dioxide content
11. Loss on drying
 WEEKII-6thJ u n e 2022to11thJ u n e 2022

Date: 6th June 2022, Monday

Activity Done/observed References/discussion Lessons learnt

Quality ● Performed complete testing Understood the properties, limits,

Control of Methyl Paraben quality, and importance of testing
Department Samples. Tests included the Methyl Paraben Sample.
are-
1. Sulphated Ash
2. Chlorides
3. Sulphates
4. Identification
5. Appearance
6. Loss on drying
7. Solubility
8. Acidity

Date: 7th June 2022, Tuesday

Activity Done/observed References/discussion Lessons learnt

Quality ● Performed complete testing Understood the properties, limits,

Control of Propyl Paraben Samples. quality, and importance of testing
Department Tests included are- the Propyl Paraben Sample.
1. Sulphated Ash
2. Chlorides
3. Sulphates
4. Identification
5. Appearance
6. Loss on drying
7. Solubility
8. Acidity
● Viscosity Test of
Gelatin sample using
viscometer.
● Quantitative Analysis of Ink
content in Capsule
 Date:8thJune2022,Wednesday
Activity Done/observed References/discussion Lessons learnt

Quality ● Performed Acid Value ● Understood the properties, limits,

Control testing of Polysorbate 80 quality, and use of Polysorbate 80
Department (Tween 80) in pharmaceutical industry.
● Performing Purified water ● Trend analysis should be done to
trend analysis from 4 ensure that the raw material
different locations. samples produced and procured
● Performing Raw material from different vendors are within
gelatin data and trend limits and can be used.
analysis
● Quantitative analysis of
Ink content per capsule
● Inventory management of
glassware apparatus

Date: 9th June 2022, Thursday

Activity Done/observed References/discussion Lessons learnt

Quality ● Performed complete testing Understood the properties, limits,

Control of Polysorbate 80 (Tween quality, and importance of testing
Department 80) Tests included- the Polysorbate 80 Sample.
1. Solubility
2. Appearance
3. Acidity
4. Aldehyde and ketones
5. Refractive Index
6. Assay
7. Acid Value
● Quantitative Analysis of
Ink content in Capsule
 Date:10thJune2022,Friday
Activity Done/observed References/discussion
Quality ● Performed complete testing
Control of Titanium dioxide
Department ● Glassware apparatus
Inventory management and
storage
● Established chemical
compatibility between
different chemicals stored.
Hence, changed the
previous storage scheme
from alphabetical storage to
storage based on chemical
and GHS
compatibility
Date: 11th June 2022, Saturday
Activity Done/observed References/discussion
Quality ● Performed complete testing
Control of Gelatin samples
Department ● Performed dilution of the
pigment samples and
measured absorbance using
UV spectrophotometer.
Lessons learnt
● Understood the importance of
appropriate storage of chemicals,
as per the chemical compatibility
and GHS guidelines.
● Learnt the use of Titanium
dioxide in capsule
manufacturing and the
importance of performing the
tests.
Lessons learnt
● Underwent hands on training on
operating UV spectrophotometer,
pH meter, Conductivity meter,
Oswald’s viscometer, and Bloom
strength apparatus
 WEEKIII-6thJ u n e 2022to11thJ u n e 2022

Date: 13th June 2022, Monday

Activity Done/observed References/discussion Lessons learnt

Quality ● Performed testing of Understood the properties, limits,

Control Glacial Acetic acid quality, and importance of testing
Department sample. Tests included the Glacial acetic acid Sample.
are-
1. Acetate test
2. Chloride test
3. Sulphate test
4. Heavy metals test
● Preparation of
Lanthanum nitrate
solution
● Preparation of Standard
Ethanolic sulphate
solution
● Preparation od Iodine
solution
● Sampling of ethylene
glycol monoethyl ether
● Sampling of Potassium
thiocyanate

Date: 14th June 2022, Tuesday

Activity Done/observed References/discussion Lessons learnt

Quality ● Performed testing of ● Understood the properties, limits,

Control Ferric Oxide Black quality, and importance of testing
Department pigment. Tests included the Ferric oxide black Sample.
are- ● Understood the working of
1. Solubility several apparatus and their
2. Water soluble matter importance in pharmaceutical
3. Identification industry
4. Loss on ignition ● Learnt the use of Tannic and Picric
5. Assay acid solution for simple
● Briefing about- identification of Gelatin Capsules.
1. Capsule processing
2. HPLC
3. Karl Fischer apparatus
Including, detailed
explanation of its working,
parts, and apparatus
● Tannic acid (10% w/v)
and Picric acid (1% w/v)
WEEKIII-6thJ u n e 2022to11thJ u n e 2022
solution
preparation, which was
further
 used for the identification
test of gelatin capsules.
(When 1 capsule is
dissolved by heating in 50
ml water, it is centrifuged
and to the supernatant when
picric or tannic acid solution
is added, a white precipitate
is formed indicating a
positive result)

Date: 15th June 2022, Wednesday

Activity Done/observed References/discussion Lessons learnt

Quality ● Preparation of ● Understood the properties, limits,

Control Potassium quality, and importance of testing
Department Permanganate reagent the Gelatin Sample.
● Standardization of 0.01 M ● The % gumming is calculated by
and 1 M Sodium hydroxide first finding out the total weight of
using Potassium hydrogen total label (3 layers) then by
Phthalate. measuring the levels of individual
● Preparation of Tannic and layers. The adhesive present is to
Picric acid solution and be removed via IPA and acetone
using that for performing mixture and the total and single
the identification test of weights are remeasured. Hence,
capsules further calculating the % gumming.
● Performed complete testing
of Gelatin. Tests included-
1. Identification test-
a. Using Copper sulfate
b. Gelling Property
2. Appearance of solution
3. Residue on ignition test
4. pH, isoelectric pH
and conductivity
● Quantitative analysis of %
gumming of label
paper packaging
material.
 Date:16thJune2022,Thursday
Activity Done/observed References/discussion Lessons learnt

Quality ● Performed testing of Understood the properties, limits,

Control Isopropyl alcohol sample. quality, and importance of testing
Department Test included- the Isopropyl Alcohol Sample.
1. Description
2. Solubility (water,
chloroform, ether,
and alcohol)
3. Identification
a. Mercuric sulphate test
b. Potassium dichromate
4. Acidity/ Alkalinity
5. Aldehyde and ketones
6. Non-volatile matter
7. Water-insoluble matter

Date: 17th June 2022, Friday

Activity Done/observed References/discussion Lessons learnt

Quality ● Performed testing of ● Understood the properties, limits,

Control Isopropyl alcohol sample. quality, and importance of testing
Department Test included- the Isopropyl Alcohol Sample.
1. Distillation Range ● Received hands on training on the
2. Refractive Index use of Refractometer apparatus for
using Refractometer calculating the refractive index
3. Specific gravity at 20
C and 25 C
4. Identification test
using dimethyl amino
benzaldehyde in
sulfuric acid
5. Peroxide test
● Preparation of Methyl
Orange, Methyl Red,
Bromocresol green,
Bromophenol blue,
Bromothymol blue,
Phenolphthalein, Eosin
solution, Oracet Blue
indicators
Activity Done/observed References/discussion Lessons learnt

Quality ● Performed complete testing ● Understood the properties,

Control of Gelatin samples limits, quality, and importance
Department ● Performed dilution of the of testing the Gelatin Sample.
pigment samples and ● Importance and requirement of
measured absorbance using several volumetric solutions and
UV spectrophotometer. reagents in pharmaceutical
● Preparation of several industry.
volumetric solutions
including-
1. 0.01M
Sodium
Thiosulphat
e
2. Hydrochloric acid 0.1M
3. Dilute Hydrochloric acid
4. Dilute sulphuric acid
5. Silver nitrate solution
6. Lead nitrate solution
● Preparation of Tannic and
Picric acid solution and
using that for performing
the identification test of
capsules
 WEEK IV- 20th June 2022 to 25th June 2022
Date: 20th June 2022, Monday
Activity Done/observed References/discussion Lessons learnt

Research and ● Performed dissolution testing Understood the properties, use,

Development of HPMC capsules, involving quality, and importance of testing
department a. preparation of- HPMC capsules in pharmaceutical
Phosphate buffer and industry
HCl buffer.
b. Measuring absorbance Understood the use of
using UV specific machines and
spectrophotometer apparatus in the
● Performed disintegration pharmaceutical industry
testing of HPMC capsules
● Detailed practical
explanation about the
working of the following
apparatus-
1. Dissolution test
apparatus (12 basket
type)
2. Disintegration test
apparatus
3. Glatt Powder coater
and granulator
4. Capsule locking station
5. Induction sealer
6. Bulk and Tapped
density apparatus
7. Solid filling machine
8. Liquid filling machine
9. Powder filling
manual machine
10. Band sealing machine

Date: 21st June 2022, Tuesday

Activity Done/observed References/discussion Lessons learnt

Research and ● Performed dissolution testing Understood the properties, use,

Development of HPMC capsules, involving quality, and importance of testing
department a. preparation of- HPMC capsules in pharmaceutical
Phosphate buffer and industry.
HCl buffer.
b. Measuring absorbance Understood the importance and
using UV process of conduction of audit.
spectrophotometer
● Performed disintegration
testing of HPMC capsules
● Observed the Sun Pharma audit
of Quality control Department
 Date:22 ndJ u n e 2022 ,Wednesd
Activity Done/observed References/discussion Lessons learnt

Research and ● Performed dissolution Understood the properties, use,

Development testing of HPMC capsules, quality, and importance of testing
department involving HPMC capsules in pharmaceutical
a. preparation of- industry.
(Nutraceutical Lab) Phosphate buffer and
HCl buffer. Understood the process behind
b. Measuring development and important
absorbance using parameters to look for when
UV producing Whey protein powder in
spectrophotometer the nutraceutical lab
● Performed
disintegration testing of
HPMC capsules
● Preparation of Whey
Isolate Protein and
performed the necessary
testing on the final
product.

Date: 23rd June 2022, Thursday

Activity Done/observed References/discussion Lessons learnt

Research and ● Performed dissolution Understood the properties, use,

Development testing of HPMC capsules, quality, and importance of testing
department involving HPMC capsules in pharmaceutical
a. preparation of- industry.
Phosphate buffer and
HCl buffer. Understood the importance of band
b. Measuring sealing in liquid filled capsules.
absorbance using
UV
spectrophotometer
● Performed
disintegration testing of
HPMC capsules
● Performed Band
sealing procedure on
liquid filled capsules.
● Performed the following test
on Calcium carbonate
sample-
1. Bulk density
2. Tapped density
3. Particle size measurement
 Date:24 thJ u n e 2022 ,Frida
Activity Done/observed References/discussion Lessons learnt

Research and ● Performed dissolution Understood the properties, use,

Development testing of HPMC capsules, quality, and importance of testing
department involving HPMC capsules in pharmaceutical
a. preparation of- industry.
Phosphate buffer and
HCl buffer. Understood the detailed process
b. Measuring involved in the development of
absorbance using seamless soft shell gelatin
UV capsules.
spectrophotometer
● Received detailed practical
explanation on the process,
raw materials machinery,
and its parts, required in the
development of Seamless
soft- shell capsules
● Attended the DISSO India
2022 webinar

Date: 25th June 2022, Saturday

Activity Done/observed References/discussion Lessons learnt

Quality Control ● Performed the following Understood the properties, use,

Department
Production Department
● Received a detailed
● Received a complete round
tests on Mica based quality, and importance of testing
Titanium dioxide sample- Mica based titanium dioxide sample
1. pH
2. Solubility Understood the complete flow and
3. Loss on drying various machinery involved in the
production of capsules, along with
explanation regarding the roles of all the departments involved.
roles of different
departments in a
pharmaceutical industry
of the plant, which
included-
1. Microbiology Lab
2. Quality Assurance Lab
3. Production Area
4. Washing Area
5. Packaging, Forwarding
and Dispatch area
6. Printing Area
7. Inspection Area