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Thesis On Plant Base Oil

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Thesis On Plant Base Oil

this is thesis on plant base oil and there use cases

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Aries Gaming
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PRACTICE SCHOOL REPORT (BP705PP)

SKILL DEVELOPMENT

PREPARED BY

NAME: SAMMED JIVANDHAR PATIL

ENROLLMENT NO:2025402900118

ROLL NO: 108

UNDER GUIDANCE OF:

MS. RUMANA PATEL

M.PHARM (PHARMACOLOGY)

ASSISTANT PROFESSOR

SUBMITTED TO

SHREE DHANAVANATARY PHARMACY COLLEGE, KIM

GUJARAT TECHNOLOGICAL UNIVERSITY

IN PARTIAL FULFILLMENT OF THE REQUIREMENT FOR THE

BACHLOR OF PHARMACY

WINTER – 2023

SHREE DHANVANTARY PHARMACY COLLEGE, KIM – 254


CERTIFICATE

This is to certify that Practice School BP705PP report embodied in this entitled “SKILL
DEVELOPMENT” was carried out by PATIL SAMMED JIVANDHAR (Enrollment
No. 202540290118) studying in 7th semester B.Pharm at Shree Dhanvantary Pharmacy
College, Kim (254) for partial fulfillment of B.Pharm degree to be awarded by Gujarat
Technological University. This practice school (BP705PP) work has been carried out under
my guidance and supervision and it is up to my satisfaction.

DATE:

PLACE: KIM, (Surat)

SIGNATURE AND NAME OF STUDENT

SINGH RASHMI PUSHPENDRA

SIGNATURE AND NAME OF GUIDE SIGNATURE AND NAME OF


PRINCIPAL

MS. RUMANA PATEL Dr. M. N. NOOLVI

2
ACKNOWLEDGEMENT

This project consumed amount of work, lots of research, dedication, skills and its
implementation which would have not been possible without help, support and guidance of
many individuals and organizations. Therefore, I would like to express my sincere gratitude
to all of them.

My great pleasure to extend my deep sense of gratitude to DR.M.N.NOOLVI, principal of


SHREE DHANVANTARY PHARMACY COLLEGE, KIM for his valuable advice and
guidance during the course of my practice school training practical.

I would like to thank and express my gratitude to my project in-charge RUMANA MAM,
assistant professor at SHREE DHANVANTARY PHARMACY COLLEGE, KIM for her
cooperation and guidance throughout my practice school training practical.

I’m cordially grateful to my beloved parents and my dear friends for their moral support,
love and blessing

3
INDEX

Sr. No. Title Page No.

1 Guest Lecture 1. (Dr. Pratyush Somani)

2 Guest Lecture 2. (Mr. Anand Pande)

3 Guest Lecture 3. (Ms. Richa Patel)

4 Guest Lecture 4. (Mr. Parth Kava)

5 UV Spectroscopy

6 High Performance Liquid Chromatography(HPLC)

7 Gas Chromatography

8 Industrial Visit

9 Conclusion

10 Annexure

4
GUEST LECTURE-1

Name of Speaker: Dr. Pratyush Somani, Manager QA/RA, Purple Microport


Cardiovascular Pvt. Ltd. Sachin, Surat

Topic: Quality Assurance in medical device Industry

Date: 19/08/2023

Time: 11.00 am to 1.00 pm

• The lecture commenced with a comprehensive overview of Quality Assurance


in the medical device industry. The lecturer emphasized that QA is not merely
a process, but a commitment to ensuring patient safety, product reliability, and
adherence to regulations.
• Quality Assurance Components:
• The lecture delved into the core components of QA, highlighting design
control, risk management, regulatory compliance, supplier management,
process validation, and post-market surveillance. Each component was
explained with real-world examples to illustrate its significance.
• Regulatory Landscape:
• The guest lecturer provided an in-depth analysis of the complex regulatory
landscape governing the medical device industry. They emphasized the
importance of staying updated with regional and international regulations,
such as FDA guidelines in the United States and EU MDR in Europe.
• Balancing Innovation and Safety:
• A crucial theme of the lecture was striking the balance between innovation
and safety. The lecturer elaborated on the challenges of introducing new

5
features while maintaining the utmost safety and effectiveness of medical
devices.

• Challenges in Quality Assurance:


• The lecture addressed challenges that QA professionals encounter, including
evolving regulatory requirements, rapid technological advancements,
globalization of supply chains, and the intricate task of managing risk.
• Post-Market Surveillance:
• The guest lecturer stressed the importance of post-market surveillance in QA.
They discussed how continuous monitoring and data gathering after a device
is on the market help identify potential issues and enable prompt interventions.
• Discussion and Q&A:
• Following the lecture, an engaging discussion and question-and-answer
session allowed attendees to delve deeper into specific aspects of QA in the
medical device industry. Attendees sought clarification on topics such as risk
assessment methodologies, the impact of globalization on QA processes, and
strategies for managing regulatory changes.

6
GUEST LECTURE-2

Name of Speaker: Mr. Anand Pande, DGM Quality Control, Zydus Life Science

Topic: Good Laboratory Practice (GLP) & Schedule L-1

Date: 2/09/2023

Time: 11.00 am to 1.00 pm

Introduction
This report outlines the key aspects of Good Laboratory Practice (GLP) and Schedule L-1,
which are essential for maintaining the quality, integrity, and reliability of laboratory data in
the context of pharmaceutical and chemical industries. These guidelines ensure that
laboratories conduct experiments, studies, and tests in a systematic and controlled manner
to generate accurate and reproducible results.

Good Laboratory Practice (GLP)


Definition
GLP is a set of quality assurance principles and guidelines for the conduct of non-clinical
safety studies on pharmaceuticals, chemicals, and other products that have the potential to
impact human health and the environment. GLP ensures the reliability, integrity, and
consistency of laboratory data generated for regulatory submissions.

7
Key Principles
1. Quality System Management: Establishing and maintaining a comprehensive
quality system that covers all aspects of laboratory operations.

2. Personnel Training: Ensuring that all laboratory personnel are adequately


trained and competent to perform their assigned tasks.

3. Standard Operating Procedures (SOPs): Developing and implementing


written procedures for all laboratory activities, ensuring consistency and repeatability.

4. Facilities and Equipment: Maintaining suitable laboratory facilities and


equipment to support the conduct of studies.

5. Study Documentation: Accurate and complete documentation of all study-


related activities, observations, and results.

6. Sample Handling: Proper handling, storage, and disposal of test substances and
samples.

7. Quality Control: Regularly conducting quality control checks to monitor the


integrity of the data generated.

8. Archiving: Proper archiving of study-related records and data for future


reference and regulatory inspections.

Benefits of GLP
• Ensures the safety and efficacy of pharmaceuticals and chemicals.

• Enhances data reliability and credibility.

• Facilitates regulatory compliance and market access.

• Reduces the risk of product recalls and regulatory sanctions.

Schedule L-1 Definition


Schedule L-1 is a part of the Drugs and Cosmetics Rules in India, which lays down the
requirements for the licensing of manufacturing and sale of drugs and cosmetics. It
encompasses various aspects related to the manufacture, testing, and distribution of
pharmaceutical products.

8
Key Provisions
1. Premises and Equipment: Specifies requirements for the design, construction,
and maintenance of manufacturing and testing facilities. It also outlines guidelines for
equipment validation.

2. Personnel: Defines the qualifications and responsibilities of personnel involved


in manufacturing and quality control activities.

3. Quality Control: Describes the procedures for sampling, testing, and release of
raw materials, intermediates, and finished products.

4. Documentation: Emphasizes the importance of accurate and comprehensive


recordkeeping, including batch records, analytical data, and stability studies.

5. Labeling and Packaging: Specifies requirements for labeling, packaging, and


storage of pharmaceutical products.

6. Complaints and Recalls: Addresses procedures for handling complaints and


recalls of pharmaceutical products.

7. Batch Release: Outlines the responsibilities and requirements for batch release
by the authorized person.

Significance of Schedule L-1


• Ensures the quality, safety, and efficacy of pharmaceutical products in the Indian
market.

• Establishes a regulatory framework for drug manufacturing and distribution.

• Facilitates compliance with international quality standards, promoting export


opportunities for Indian pharmaceutical companies.

9
GUEST LECTURE-3

Name of Speaker: Ms. Richa Patel, QA Manager, Alphard Pharma, Surat

Topic: Overview of Pharmaceutical Industry

Date: 16/09/2023

Time: 11.00 am to 1.00 pm

10
Description:
1. Research and Development (R&D)
The Research and Development department is the heart of any pharmaceutical company. Its
responsibilities include:

• Drug Discovery: Identifying potential drug candidates through extensive research,


often targeting specific diseases or conditions.

• Preclinical Testing: Conducting rigorous testing in laboratories and animal models


to assess safety and effectiveness.

• Clinical Trials: Overseeing the progression of drugs through phases of human


clinical trials to evaluate safety, dosages, and efficacy.

• Regulatory Affairs: Preparing and submitting applications for regulatory approvals.

2. Manufacturing
The Manufacturing department ensures the efficient and consistent production of
pharmaceuticals:

• Drug Formulation: Developing the processes to create the final drug product,
including determining the appropriate dosage form (tablets, capsules, injections, etc.).

• Quality Control: Monitoring the quality of raw materials and finished products
through rigorous testing to meet regulatory standards.

• Scale-up Production: Transitioning from laboratory-scale production to large-


scale manufacturing.

3. Regulatory Affairs
Regulatory Affairs plays a crucial role in ensuring that pharmaceutical products meet legal
and regulatory requirements:

• Regulatory Submissions: Preparing and submitting applications for drug


approvals to regulatory agencies like the FDA (U.S.) or EMA (Europe).

• Compliance: Ensuring that the company adheres to all applicable regulations,


including labeling and advertising.

11
4. Marketing and Sales
The Marketing and Sales department focuses on promoting and distributing pharmaceutical
products:

• Market Research: Analyzing market trends, competition, and customer needs.

• Advertising and Promotion: Developing marketing campaigns and promotional


strategies.

• Sales: Managing relationships with healthcare providers, pharmacies, and


distributors.

5. Medical Affairs
Medical Affairs is responsible for providing medical and scientific expertise:

• Medical Information: Responding to inquiries from healthcare professionals


and patients about the company's products.

• Clinical Trials: Designing and managing post-marketing clinical trials to gather


additional data on product safety and efficacy.

• Key Opinion Leader Engagement: Collaborating with healthcare experts to


ensure the company's products are used effectively.

6. Quality Assurance and Compliance


Quality Assurance and Compliance oversee the company's adherence to quality standards
and regulatory requirements:

• Quality Assurance: Implementing quality control measures, conducting audits,


and ensuring that manufacturing processes meet quality standards.

• Compliance: Ensuring that the company follows all relevant regulations and
guidelines.

7. Supply Chain and Logistics


Supply Chain and Logistics manage the flow of materials, information, and products:

• Procurement: Sourcing raw materials and components required for


manufacturing.

• Distribution: Managing the distribution network to ensure timely delivery to

customers and markets.

12
8. Finance and Administration
The Finance and Administration department is responsible for the financial health of the
company:

• Budgeting: Managing budgets and financial planning for R&D, manufacturing,


and other operations.

• Administration: Handling administrative functions, including human


resources and legal affairs.

9. IT and Technology
Information Technology and Technology departments play a critical role in data
management, cybersecurity, and digital transformation:

• Data Management: Handling vast amounts of data generated during research,


clinical trials, and operations.

• Cybersecurity: Protecting sensitive information from cyber threats.

• Digital Transformation: Leveraging technology for process optimization and


innovation.

13
GUEST LECTURE-4

Name of Speaker: Mr. Parth Kava, CEO, Medlera Healthcare, Surat

Topic: Futuristic Scope of Biotechnology

Date: 22/09/2023

Time: 11.00 am to 1.00 pm

14
Introduction:

Biotechnology is the application of biological systems, organisms, or derivatives to develop


or create products or processes that improve our lives. It leverages the understanding of
genetics, molecular biology, and cellular processes to manipulate living organisms or
biological systems for practical purposes.

Futuristic Scope of Biotechnology 1. Precision Medicine


Precision medicine is a paradigm shift in healthcare. It involves tailoring medical treatments
to an individual's genetic makeup, allowing for personalized therapies. Key components of
this futuristic application include:

• Genomic Medicine: Analyzing an individual's entire genome to predict disease


susceptibility and customize treatment

• Targeted Therapies: Developing drugs that specifically target the genetic


mutations driving diseases, leading to more effective treatments with fewer side effects.

2. Gene Editing and CRISPR-Cas9


Gene editing technologies, especially CRISPR-Cas9, have opened doors to manipulate
genes with unprecedented precision. This has profound implications:

• Curing Genetic Diseases: Potential to cure genetic disorders like sickle cell
anemia and cystic fibrosis at the genetic level.

• Enhancing Agriculture: Improving crop yields and making plants more


resistant to pests and diseases.

• Ethical Considerations: Ethical debates regarding the use of gene editing in


humans, including germline editing.

3. Synthetic Biology
Synthetic biology is an interdisciplinary field that combines biology, engineering, and
computer science to design and construct new biological parts, devices, and systems. The
futuristic applications are vast:

• Biofuel Production: Engineering microorganisms to produce sustainable biofuels,


reducing reliance on fossil fuels.

• Bio-Computing: Creating biological computers for data storage and processing.

• Biological Sensors: Developing biological sensors for environmental monitoring


and disease detection.

4. Regenerative Medicine
Regenerative medicine holds the promise of replacing or regenerating damaged tissues and
organs:

15
• Stem Cell Therapy: Using stem cells to repair damaged tissues and treat
conditions such as spinal cord injuries and heart disease.

• 3D Bioprinting: Printing functional organs, like kidneys or hearts, using a


patient's own cells, reducing the need for organ transplantation.

5. Bioinformatics and Big Data


The integration of biotechnology with bioinformatics and big data analytics is transforming
research and healthcare:

• Drug Discovery: Accelerating drug discovery by analyzing massive datasets of


molecular interactions and drug responses.

• Personalized Medicine: Leveraging patient data for tailored treatment plans


and early disease detection.

6. Environmental Biotechnology
Biotechnology can contribute significantly to solving environmental challenges:

• Bioremediation: Using microorganisms to clean up pollutants in soil and water.

• Biofuels and Green Chemistry: Developing environmentally friendly alternatives


to traditional industrial processes.

7. Nanobiotechnology
Nanobiotechnology involves the integration of nanotechnology and biotechnology for
novel applications:

• Drug Delivery: Precise drug delivery systems using nanoparticles to target specific
cells or tissues.

• Diagnostic Tools: Highly sensitive nanosensors for early disease detection.

16
EQUIPMENTS USED IN QA DEPARTMENT

QA (QUALITY ASSURANCE)

It is the way of preventing mistake and defects in manufactured products and avoiding
problems whe services is delivered to customers.

The basic two principle of QA are:

1. Fit for purpose-“the product should be suitable for intended purpose”

2. Right first time-“mistake should be eliminated”

It includes management of quality of raw material, assemblies, products, components,


services related to production and management along with regular inspection processes.

Now in pharmaceutical industries QMP and cGMP are very important aspects in an
organization.

cGMPs noe generally recognize(QA-compliance,QC Testing) cGMP:

QA Qulity Assurance

QC Quality Control

In the pharmaceutical industry, qulity assurance (QA) is essential for ensuring that
pharmaceutical product are manufactured to a safe and consistent standard.

QA is area that refers to any aspect that affect a drugs quality during its research, development
and manufscturimg.

17
List of Quality Eqipment:
Crock meter

Electric Balance

Iorn

Qulity assurance tester

Cloth Measuring Tape

18
UV SPECTROPHOTOMETRY

19
packets of photons. The relation between the energy of a photon and the frequency
appropriate for the description of its propagation is
E = hv
Where, E = Energyinergs
v = Representsfrequency incyclespersecond
h = Plank's constant (6.6256 x 10-27 erg-sec)
The data obtained from a spectroscopic measurement are in the form of a
plot of radiant absorbed or emitted as a function of position in the
electromagnetic spectrum. This is known as a spectrum and the position of
absorption or emission is measured in units of energy, wavelength or
frequency.
Beer-Lambert’s law:
Colorimetry is the determination of the light absorbing capacity of a system. A
quantitative determination is therefore, carried out by subjecting a colored
solution to those wavelengths of visible energy which are absorbed by that
solution. UV and visible absorption bands are due to electronic transitions in
the region of 200 nm to 780 nm. In case of organic molecules, the electronic
transitions could be ascribed to a s, p or n electron transition from the ground
state to an excited state (s*, p* or n*).There are four types of absorption bands
that occur due to the electronic transition of a molecule. R - Bands: n p*, in
compounds with C=O or NO2 group k - Bands: p p*, in conjugated systems.
b - Bands (Benzenoid bands): Due to aromatic and heteroaromatic systems
E - Bands (ethylenic bands): In aromatic systems.
When light (monochromatic or heterogeneous) falls upon a homogeneous
medium, a portion of the incident light is reflected, a portion is absorbed within
the medium and the remainder is transmitted. If the intensity of the incident
light is expressed by I, that of the absorbed light by Ia, that of the transmitted
light by It, and that of the reflected light by Ir, then:

Credit for investigating the change of absorption of light with the thickness
medium is frequently given to Lambert; Beer later applied similar experiments to
20
solutions of different concentrations and published his results. The two separate
laws governing absorption are usually known as Lambert's law and Beer's law. In
the form they are referred to as the Beer-Lambert law. Mathematically, the
radiation-concentration and radiation-path length relation can be expressed by
......................(2)
The more familiar equation used in spectrometry
log (I/I0) = a* c * l ...................(3)

I0 = intensity of the incident energy


I = intensity of the emergent energy

c = concentration
l = thickness of the absorber (in cm) a = molar
absorbtivity for concentration in moles/L
Represents a concentration of 1% w/v and 1 cm cell thickness and is used
primarily in the investigation of those substances of unknown or undetermined
molecular weight.
PRINCIPLE OF QUANTITATIVE SPECTROPHOTOMETRIC ASSAY OF
MEDICINAL SUBSTANCES:
The assay of an absorbing substance may be quickly carried out by preparing a
solution in a transparent solvent and measuring its absorbance at a suitable
wavelength. The concentration of the absorbing substance calculated from the
measured absorbance using one of three principal procedures.

21
UV-VISIBLE INSTRUMENTATION COMPONENTS OF UV-VIS
SPECTROPHOTOMETER:
1. SOURCE
2. COLLIMATING SYSTEM
3. MONOCHROMATORS
4. SAMPLE HOLDER
5. DETECTORS
6. READ OUT DEVICES

1.
2.
3.
4.

1.Lenses

2.Mirrors

3.Slits

22
Monochromators
1.Fiters
2.Prisms
3.Gratings

Detectors
1.Barrier Layer Cell/Photovoltaic cell
2.Phototubes/Photo emissive tube
3.Photomultiplier tube

Read out Devices


SINGLE BEAM INSTRUMENT:
One simple and widely used spectrophotometer is Spectronic 20 manufactured by
Milton Roy Company.
CONSTRUCTION:

The Spectronic 20 is equipped with Tungsten filament light source operated by


astabilized power supply. The intensity of radiation from the lamp is sufficiently
constant to produce reproducible data. Radiation from the source passes trough a
fixed slit to the surface of reflection grating. The diffracted radiation then passes
through an exit slit to the cuvette and then to a phototube. The amplified electrical
single from the detector power is measured. The amount of current detected
corresponds to the radiant energy falling on phototube. The S-20 is equipped with
an occludr, which is a vane that automatically falls between the beam and the
detector wherever the cuvette is removed from its holder. The light control devices
consists of V shaped aperture that is moved in and out of the beam to control the
intensity of the beam falling on Phototube.

23
24
25
Calibration SOP of UV

5.1 Control of Wavelength:


5.1.1 Reagents:
Perchloric acid (70.0% AR Grade), Purified water.
5.1.2 Preparation of 1.4M Perchloric acid solution.
Pipette 11.5 mL of Perchloric acid (70.0%) into 100 mL volumetric flask and add
30 mL water, mix well and make up the volume with water.
5.1.3 Preparation of Holmium perchlorate solution.
15 mL of 1.4M Perchloric acid solution, heat on a water-bath to dissolve, cool to
room temperature and make up the volume with 1.4M Perchloric acid solution.
5.1.4. Scan this solution in the range of 200 nm to 800 nm, using 1.4M Perchloric
acid as a blank. using 1 cm cuvette.
5.1.5. Check the observed maxima against the acceptance criteria, which are given
below:
Maximum at 241.15 ±1 nm (240.15 to 242.15)
287.15 ±1 nm (286.15 to 288.15)
361.50 ±1 nm (360.50 to 362.50) 536.30 ± 3 nm (533.30 to 539.

5.2 Control of Absorbance:

5.2.1 Reagents:
Sulphuric acid (AR Grade),
Purified water,
Potassium dichromate (AR Grade).

26
5.2.2 Preparation of 0.005M Sulphuric acid solution:
Pipette 5.4 mL of Sulphuric acid in 100 mL volumetric flask and add 30 mL
water, mix well and make up volume with water. Pipette 10.0 mL of above
solution in 2000 mL volumetric flask, make up volume with water.
5.2.3 Preparation of Potassium dichromate solution: Use potassium
dichromate after reading instructions from the supplier COA, if not specified
in the supplier's COA then proceed as per the reagent preparation provided in
pharmacopoeia. Weigh accurately about 60 mg (57.0 mg to 63.0 mg)
Potassium dichromate into a 100 mL volumetric flask. Add 30 mL 0.005M
Sulphuric acid, dissolve and make up the volume with 0.005M Sulphuric acid.
(Use this solution for 430 nm)
Pipette 10 ml of above solution in 100 ml volumetric flask and dilute to
volume with 0.005M Sulphuric acid solution. (Use this solution for 235nm,
257 nm, 313nm, 350nm).
5.2.4 Check the absorbance of Potassium dichromate solution, using 0.005M
Sulphuric acid as a blank at the following wavelengths: 235, 257, 313 and 350
nm. Calculate the value of Specific absorbance "A (1%, 1-cm)" as per the
following formula:
A (1%,1 cm) = Absorbance x 10 x 1000
Weight of K,Cr,O, in mg

The expression A (1%, 1cm) representing the Specific absorbance of dissolved


substance refer to the absorbance of a 1.0% w/v solution in a 1cm cuvette.
Where, 1000 is used to convert weight of K,Cr,O, from milligram to gram, and
10 is used for 1% w/v (1% w/v 1000 mg/100 mL i.e. 10). 5.2.2.5. Check the
absorbance of Potassium dichromate solution, using 0.005M Sulphuric acid as
a blank at the 430 nm. Calculate the value of Specific.
'absorbance 'A (1%, 1-cm)' as per the following formula:
A (1%,1 cm) = Absorbance x 1000

27
---------------------------
Weight of K,Cr₂O, in mg
The expression A (1%, 1cm) representing the Specific absorbance of dissolved.

Substance refer to the absorbance of a 1.0% w/v solution in a 1cm cuvette.


Where, 1000 is used to convert weight of K, Cr₂O, from milligram to gram.

5.3

Wavelength (nm) Acceptance Criteria (Specific absorbance)


volume with water.

5.3.3 Scan the solution between 190 nm to 220 nm, use water as a blank.
using 1 cm cuvette

28
5.3.4. Acceptance criteria:
The absorbance of the above solution at 198 nm should not be less than 25.4
Resolution:
5.4.1 Reagent:
Toluene (AR Grade), Hexane (AR Grade).
5.4.2. Preparation of 0.02% v/v solution of toluene in hexane: Pipette 1.0 mL of
Toluene into 50 mL volumetric flask and add 30 mL hexane, shake for few minutes
and make up volume with hexane.
Pipette 5.0 mL of above solution into 50 mL volumetric flask and make up the volume
with hexane.
Further pipette 5.0 mL of above solution into 50 mL volumetric flask and make up the
volume with hexane.
5.4.3 Scan the sample between 260 nm to 275 nm. Use hexane as a blank. using 1 cm
cuvette
5.4.4 Check the absorbance maximum at 269 nm and minimum at 266 nm. Take the
ratio of absorbance of 269 nm and 266 nm and fill the data as per Annexure-II.
5.4.5 Acceptance Criteria:
Ratio of absorbance about 269 nm and 266 nm is not less than 1.5.
5.5 Resolution Power (Secondary Derivative):
5.5.1 Reagent:
Toluene (AR Grade), Methanol (HPLC Grade).
5.5.2 Preparation of 0.02% v/v solution of toluene in methanol: Pipette 2.0 ml. of
Toluene into 200 mL volumetric flask and add 50 ml. methanol, shake for few minutes
and make up volume with methanol. Pipette 2.0 mL of above solution into 100 ml.
volumetric flask and make up the volume with methanol.
5.5.3 Instrument Method Parameter
Measuring Mode: Spectrum Slit With: 1.0 nm
Wavelength: 255 nm to 285 nm
Sampling Interval: 0.05

29
Scaling Mode: Slow
5.5.4 Perform the baseline correction in the range 255 to 285 nm for spectrum. Use
methanol as blank, using 1 cm cuvette
5.5.5 Scan the sample between 255 nm to 285 nm and save the spectra.
5.5.6 Click the 'Manipulate' option; screen will appear with 'Type, Dataset, Operation,
Constant and Calculate'

30
5.5.7 Set the above-mentioned parameters as below, 5.5.12

Acceptance Criteria: Not less than 0.2

5.6 Make entry of calibration in the equipment logbook as per SOP QC-088.

5.7 Record all the results of calibration as per Annexure-II.


5.8

5.9

5.10

5.10.1

31
FTIR (Fourier Transform Infrared Spectroscopy)
A method of obtaining an Infrared spectrum by measuring the interferogram

of a sample sing an interferometer, then performing a Fourier Transform upon

the interferogram to obtain the spectrum.

Furie Transform Infrared (FTIR) spectroscopy is an analyticl methodology

used in industry and academic laboratories to understand the structure of

individual molecules and the composition of molecular mixtures. FTIR

spectroscopy uses modulated, mid-infrared energy to interrogate a sample.

The infrared light is absorbed at specific frequencies directly related to the

atom-to-atom vibrational bond energies in the molecule. When the bond

energy of the vibration and the energy of mid-infrared light are equivalent, the

bond can absorb that energy. Different bonds in a molecule vibrate at different

energies, and therefore absorb different wavelengths of the IR radiation. The

position (frequency) and intensity of these individual absorption bands

contribute to the overall spectrum, creating a characteristic fingerprint of the

molecule.

FTIR spectroscopy has broad use and applicability in the analysis of


molecules important in the pharmaceutical, chemical and polymer industries.
FTIR analysis is used in both industry and academic laboratories to better
understand the molecular structure of materials as well as the kinetics,
mechanism and pathways in chemical reactions and catalytic cycles. FTIR
spectroscopy is used to ensure that raw materials, intermediate compounds
and final products are within specification. In chemical and pharmaceutical
R&D, in-situ FTIR spectroscopy is used to help scale up chemical

32
Reactions optimize reaction yield and minimize by-product impurities. In
chemical and pharmaceutical production, FTIR spectroscopy functions as a
process analytical technology (PAT), ensuring that processes are stable and in
control and achieve final product specifications.

Work:

To measure chemistry in real time requires the transfer of modulated infrared


radiation into a reaction vessel or continuous flow apparatus, and then the
return of the unabsorbed energy to the spectrometer. To accomplish this, React
IR technology uses an internal reflection (Attenuated Total Reflectance/ATR)
sensor mounted at the end of a tubular optical probe that can be inserted into a
chemical reaction, or an ATR sensor that is an integral part of a cell
monitoring continuous flow reactions.

33
The ATR method is an ideal complement to FTIR instrumentation for analysis
and monitoring of chemical reactions. The restricted depth of penetration of
the infrared energy into the sample permits high-quality FTIR spectra of
optically dense reaction mixtures. The neat solution phase of a chemical
reaction is measured and bubbles, particles, catalysts, biological solids, water,
etc., do not interfere with the measurement.
Suitable ATR sensors for analyzing chemical reactions must have the requisite index
of refraction to enable internal reflection and must also perform in harsh chemical
environments without degrading. Both diamond and silicon are excellent sensor
materials for FTIR-ATR, and the choice of which to use is dependent on the type of
chemistry and the infrared peak positions that need to be tracked.

CALIBRATION OF FTIR:

Calibration (Verification of the wave-number scale) of FTIR Spectrometer:

Follow the operational procedure and record the Spectrum


of
the Polystyrene film over the range of 3800 cm-1 to 650 cm-1.

Record the wave number in attachment no. 01.

The spectrum should show the Transmission minima (absorption maxima) at


the wave-number given in the attachment no. 01

Validation Procedure of FTIR Spectrometer:

Ensure that, the instrument is ready for calibration and the start-up procedure
is followed.

Calibrate the instrument for power spectrum, resolution, wave number


accuracy, repeatability of wave-number and repeatability of absorbance.

Ensure that the Instrument is ready for the calibration and start-up the
procedure is followed.

Initialized the instrument.

Click on the icon Measurement, select “EP5.0 validation”.

34
After selecting “EP 5.0 validation”.

Click on “Measurement”.

Verify the necessary information or change the details as per requirements.

Click on “OK” to start the background.

After background validation completion,“ Set polystyrene film into the sample
chamber” is displayed in the screen.

Set the polystyrene film accordingly and click on “OK”, scanning will start.

After completion of the validation the report will be generated and printed
automatically.

Compare the results for its compliance against limits given in validation
format and put remark regarding validation status.

Make entry of the usage into the Instrument usage logbook.

Calibration report shall come in form of validation format at the time of


printing.( Annexure-2)

File the validation report duly signed and checked.

Affix calibration label on the instrument.

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HPLC AND GC DEMONSTRATRION

HPLC (High Performance Liquid GC (Gas Chromatography)


Chromatography)

High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) are two
common techniques used for chemical analysis and separation of compounds. Here's a brief
overview of how to use each of these techniques:

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HPLC (High-Performance Liquid Chromatography):

1. Sample Preparation:

- Prepare your sample by dissolving or suspending it in a suitable solvent. Ensure the sample
is filtered to remove particulate matter if necessary.

2. Instrument Setup:

- Turn on the HPLC instrument and allow it to equilibrate.

- Install the appropriate column (stationary phase) for your analysis.

- Set the flow rate, temperature, and detector settings according to your method.

3. Mobile Phase:

- Prepare the mobile phase, which is a solvent or solvent mixture. It should be filtered and
degassed to remove air bubbles.

- Ensure that the mobile phase is compatible with your sample and column.

4. Sample Injection:

- Inject your prepared sample into the HPLC instrument. This can be done manually or using
an autosampler.

5. Separation:

- Start the HPLC run, and the sample will pass through the column.

- The components in your sample will interact with the stationary phase, causing separation
based on their chemical properties (e.g., size, polarity).

6. Detection:

- The separated components will pass through a detector (e.g., UV, fluorescence, or mass
spectrometry) that quantifies their presence.

- Collect and analyze the data generated by the detector.

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7. Data Analysis:

- Analyze the chromatogram to determine the retention times, peak shapes, and areas for each
component.

- Compare your results with standards or known compounds for identification and
quantification.

8. Maintenance:

- After your analysis, flush the column with a suitable solvent to clean it.

- Properly shut down the HPLC instrument, ensuring it is ready for the next use.

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GC (Gas Chromatography):

1. Sample Preparation:

- Prepare your sample by dissolving it in a suitable solvent or converting it to a gas (if


necessary).

2. Instrument Setup:

- Turn on the GC instrument and allow it to equilibrate.

- Install the appropriate column for your analysis (e.g., capillary column).

3. Carrier Gas:

- Select a carrier gas (e.g., helium, nitrogen) and set the flow rate.

- Ensure the carrier gas is high purity and free of impurities.

4. Sample Injection:

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- Inject your sample into the GC instrument, either manually or using an autosampler.

5. Separation:

- Start the GC run, and the sample will be vaporized and pass through the column.

- Separation occurs based on the interaction of the sample with the stationary phase within
the column.

6. Detection:

- As the separated components exit the column, they pass through a detector (e.g., FID, TCD,
ECD) that measures their concentration.

7. Data Analysis:

- Analyze the chromatogram to determine retention times and peak areas.

- Identify and quantify compounds by comparing retention times with standards or known
compounds.

INDUSTRIAL VISITS
Skill Development Program
Industrial Visit

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Name of Company: Ribosome research Centre

Address: Sr No.261/1, Block No. 271, near Shri Dhanvantary Pharmacy College,
Kim, Gujarat 394110

Date: 26/08/2023

Time: 9.30 am to 3.00 pm

Participated Year: 4th Year B.Pharm

Introduction:
The industrial visit to the Ribosome Research Centre offered a distinctive opportunity
for participants to gain profound insights into the cutting-edge advancements within the
realm of molecular biology and biotechnology. Renowned for its pioneering research in
ribosome structure, function, and its roles in diverse cellular processes, the Ribosome
Research Centre was the focal point of this enlightening experience. During the visit,
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attendees had the privilege of touring the laboratory facilities, engaging with
researchers, and directly witnessing ongoing research endeavors.

Objectives:
1. To grasp the significance of ribosome research in the domains of molecular biology
and cellular processes.
2. To acquire knowledge about the state-of-the-art laboratory techniques and equipment
employed in ribosome research.
3. To observe practical applications of ribosome research in the realms of biotechnology
and medicine.

Activities and Observations:


1. Laboratory Tour: The visit commenced with an extensive tour of the laboratory
facilities. Attendees were introduced to various sections of the laboratory,
encompassing advanced microscopy labs, protein analysis units, and DNA sequencing
setups. Researchers elucidated the critical role of each section in the research process.

2. Presentation on Ribosome Structure and Function: A senior researcher delivered a


comprehensive presentation on ribosome structure and function. The presentation
covered topics including ribosome composition, the translation process, and the integral
role of ribosomes in protein synthesis. Participants gained valuable insights into the
intricacies of these molecular machines.

3. Live Experiments: Participants were afforded the opportunity to witness live


experiments involving ribosome analysis. Researchers demonstrated techniques such
as cryo-electron microscopy, which allows the visualization of ribosome structures at
near-atomic resolution. This highlighted the interdisciplinary nature of ribosome
research, integrating biology, chemistry, and physics.

4. Interaction with Researchers: A highlight of the visit was the direct interaction with
researchers and scientists at the centre. Participants engaged in in-depth discussions

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regarding ongoing projects, research challenges, and the potential applications of
ribosome research in various domains, such as drug discovery and genetic engineering.

5. Application in Medicine: A dedicated session shed light on the medical implications


of ribosome research. Researchers discussed how understanding ribosome malfunction
could yield insights into various genetic disorders and diseases. This underlined the
potential for targeted therapies and precision medicine.

6. Q&A Session: The visit concluded with a question and answer session, affording
participants the opportunity to seek clarification on various aspects of ribosome
research and delve deeper into specific areas of interest.

Key Takeaways:
1. Ribosome research is a multidisciplinary field of paramount importance in
comprehending cellular processes and molecular biology.
2. Advanced techniques, such as cryo-electron microscopy, have revolutionized our
capacity to study ribosome structures at exceptionally high resolutions.
3. Ribosome research extends its influence into diverse domains, including medicine,
genetic engineering, and biotechnology.

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ALPHARD PHARMA: -

45
46
QUALITY MANAGEMENT SYSTEM: -
Short description of the Quality Management System of the firm
responsible for Manufacturing Quality division of Alphard Pharma is a
distinct organization body that functions and reports to authorized
partners and is independent of all other plant functions. Head of Quality
division is technically qualified with remarkable experience in the
responsible area. Site In charge – Quality Assurance reports to
Managing Director.
Alphard has adopted a policy of operating the pharmaceutical
manufacturing under control of Quality Management System, installed
and operating as stated under the Quality Manual. It is also our policy
to update the standards as per WHO, cGMP and customer requirements
with mutual dialogue. The quality control department is fully
authorized to take appropriate decision on quality matters.
Departments of ALPHARD

1.Qurantine Room

2. Raw Material Room

3. Tablet Inspection Room 4. Bottle Cleaning Room

5. Raw Material Dry Store

6. Semi Finished Quarantine Room

7. Instrument Room
8. Physico-chemical Lab

9. Retain Sample Room

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10

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ZYDUS LIFESCIENCES

LIMITED

Zydus shall be leading healthcare provider with robust product


pipeline: Stepping beyond the billion, we shall achieve of over USD 3 billion in
2015and be a research based Pharma company by 2020.
API shall contribute to this by being reliable service provider to Customer,
maintaining cost comp our customer, maintaining cost competitiveness through
Continuous improvement in process, offering quality product keeping prime
focus on environment, health safety...
Mission: -
To unlock new possibilities in life-sciences through quality healthcare solutions
that impact lives.

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Purpose: Empower people with the freedom to live healthier and more fulfilled
lives.

ZYCOV-D virus and elicits an immune response mediated by the


cellular and humoral arms of the humanyCoV-D is a Plasmid DNA
vaccine that produces the spike protein of the SARS-C immune system,
which play a vital role in protection from disease as well as viral
clearance.

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• Nutralite. Healthier & Delicious.
• Sugar Free Product:
From twenty-five pharmaceutical production operations in India and
Zydus Cadila develops and manufactures an extensive range of
pharmaceuticals as
well as diagnostics, herbal products, skincare products and other OTC
products. Starting from late 2015, having concluded a voluntary license
agreement with Gilead, the company also produces the generics for
hepatitis C treatment
(i.e. sofosbuvir, distributed under the brand name SoviHep).

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Ranitidine (Zydus) 300 mg tablet:

• USES:
• Gastric and duodenal ulcers
• Gastroesophagal Reflux Disease
• Erosive Esophagitis
• Zollinger-Ellison Syndrome
• Hypersecretory Condition

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Antiseptic:
53
54
Conclusion
Hands on training of different equipments like FTIR, UV spectroscopy, HPLC, GC, flame

photometry of QA department use to check the quality of different dosage forms helps us for

better and detailed operative or practical knowledge and to develop our skills in these

instruments so that in future we would have better practical knowledge in operating these

instruments and will be easily eligible for job in FDCA related and QA related jobs in

industries.

Seminar sessions in this program teaches about theoretical and informative knowledge of

different cGMP guidelines, about schedule-M ,UV , IR spectroscopy, NMR spectroscopy,

about different schedules, HPLC, Quality and safety guidelines organized by different

professors ,FDCA commissioner, Drug inspector ret. assistant professor which helps in

increasing our knowledge in these subjects.

One of the major part in skill development was industrial visit organized by our college at

Alphard pharma which is a small scale industry and other visit was in Zydus life sciences

which is an API unit in Ankleshwar. This visit gives us a thoroughly practical knowledge

about how a drug is made starting from getting raw material to the packaging and how the

API plant operates and safety guidelines to keep during working in industry.

I learned a lot of things in this program and feeling grateful to be a part of this program and

learned a lot of new things which will be never taught in any colleges or universities.

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ANNEXURE

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