Name: Darshil Prajapati

Roll no.: 43

Industrial Visit Report: Sumar Biotech LLP

Introduction: An industrial visit was organized for students to gain practical insights into the
operations of a pharmaceutical company. The visit took place at Sumar Biotech LLP, located in
Gozariya, Mehsana, Gujarat. The purpose of the visit was to enhance the student's understanding
of the pharmaceutical industry, its manufacturing processes, quality control measures, and
regulatory compliance.

Company Overview: Sumar Biotech LLP is a leading pharmaceutical company that specializes
in the development, manufacturing, and distribution of a wide range of pharmaceutical products
[API], including generic drugs, and over-the-counter products. The company is known for its
commitment to quality, research, and technological innovation.
The industrial visit was conducted on 05.08.2023 by the Department of Microbiology, LJ
University, Ahmedabad, Gujarat.

Objectives of the Visit:

Gain practical knowledge about pharmaceutical manufacturing processes.
Understand the quality control and assurance procedures in the pharmaceutical industry.
Learn about the company's research and development efforts.
Explore the regulatory requirements and compliance in the pharmaceutical sector.

Activities and Observations:

During the industrial visit, students were guided through various departments within the
company, including:

Warehouse: Warehouses are important in the pharmaceutical sector since they serve as storage
and distribution centers for numerous pharmaceutical items. Warehouses are used extensively in
the pharmaceutical sector. Raw Material Storage: Raw materials such as active pharmaceutical
ingredients (APIs), excipients, and packaging materials are stored in warehouses before being
used in the manufacturing process. Warehouses provide a regulated environment for keeping
finished pharmaceutical items prior to distribution to wholesalers, retailers, or directly to
customers.

Research and Development (R&D): Students were given an overview of the R&D department,
where they learned about the drug discovery process, formulation development, and preclinical
testing.

Production Unit: Production is done in different batches. Two types of reactors in this unit. SSR
for neutral & basic material, and GLP for acidic material.

Quality Control and Quality Assurance: The QC/QA department emphasized the importance
of testing raw materials, in-process samples, and finished products to ensure they meet
established specifications.
Instruments:

Weighing Balance: Weighing balances play a pivotal role in the pharmaceutical sector by
accurately measuring and dispensing raw materials, active components, and final products.

pH Meter: pH meters hold essential significance in the pharmaceutical industry as they are
fundamental tools for gauging the acidity or alkalinity of diverse substances, encompassing
medications, solutions, and raw materials.

Vortex Mixer: Vortex mixers find widespread usage in the pharmaceutical domain, serving
various purposes such as mixing, blending, dissolving, and resuspending substances.

Autoclave: Autoclaves are integral to the pharmaceutical sector for sterilizing equipment,
instruments, and materials, ensuring their freedom from harmful microorganisms. This is crucial
in maintaining the quality and safety of the manufacturing process.

Incubator: Incubators are commonly employed in the pharmaceutical industry to create

controlled environments for nurturing and testing a variety of biological materials.

Quality Tests:

Microbial Limit Test: The microbial limit test is a quality control procedure essential in the
pharmaceutical sector to verify the absence of detrimental levels of microorganisms in
pharmaceutical products. This evaluation entails testing samples for the presence of bacteria,
yeast, and, molds, with the ultimate objective of preventing contamination that could jeopardize
the safety and efficacy of the product.

Bacterial Endotoxin Test: The bacterial endotoxin test (BET) holds immense importance as a
quality control measure in the pharmaceutical arena. It facilitates the detection and quantification
of bacterial endotoxins, toxins discharged from certain bacteria's cell walls. This examination
guarantees the safety of drugs, medical devices, and other products that come into contact with
the human body.

Growth Promotion Test: The Growth Promotion Test is a vital quality control process within
the pharmaceutical sector. It encompasses evaluating a culture medium's capacity to support the
growth of specific microorganisms. This examination ensures the suitability and effectiveness of
the culture medium used for microbial testing, a critical aspect for accurately assessing
pharmaceutical products for microbial contamination.

Product Purification: High-Performance Liquid Chromatography (HPLC): HPLC, which

stands for High-Performance Liquid Chromatography, is a methodology employed not only in
the pharmaceutical sector but also in other domains to segregate, identify, and quantify diverse
components within a mixture. Its application is especially valuable in the pharmaceutical
industry for scrutinizing and ensuring the quality of pharmaceutical products, guaranteeing
adherence to safety and effectiveness benchmarks. HPLC plays a pivotal role in identifying
impurities, analyzing drug formulations, and determining the concentration of active
pharmaceutical constituents.

Polarimeter: In the pharmaceutical field, a polarimeter serves the purpose of ascertaining

optical rotation, often employed to gauge the interaction of substances with polarized light.
Ultraviolet (UV) Spectroscopy: UV spectroscopy, also recognized as ultraviolet-visible
spectroscopy, is a technique extensively utilized within the pharmaceutical sector to scrutinize
and characterize diverse compounds. This methodology revolves around the assessment of the
absorption of ultraviolet (UV) and visible light by molecules present in the sample.

Stability Chamber: In the realm of pharmaceuticals, a stability chamber functions as a regulated

setting designed for assessing the durability and lifespan of drugs, vaccines, and related items. It
replicates various environmental factors such as temperature, humidity, and light to observe the
gradual deterioration of a product throughout its lifespan.

Regulatory Compliance: Company representatives highlighted the significance of adhering to

regulatory guidelines and obtaining approvals from health authorities. This included discussions
on Good Manufacturing Practices (GMP) and quality audits.

Key Learnings:
Pharmaceutical Manufacturing: Students gained a comprehensive understanding of the step-
by-step manufacturing process for various pharmaceutical products.

Quality Standards: The importance of maintaining stringent quality control measures to ensure
the safety and efficacy of pharmaceutical products was emphasized.

Regulatory Environment: Students learned about the complex regulatory landscape in the
pharmaceutical industry and the company's efforts to comply with various regulations.

R&D Efforts: Insights into the research and development activities highlighted the company's
commitment to innovation and continuous improvement.

Conclusion: The industrial visit to Sumar Biotech LLP provided students with valuable
exposure to the inner workings of a pharmaceutical company. It helped bridge the gap between
theoretical knowledge and practical applications in the pharmaceutical industry. Students left the
visit with a deeper appreciation for the challenges and complexities involved in producing safe
and effective medicines while complying with regulatory standards. The experience enriched
their understanding of the pharmaceutical sector and will contribute to their future endeavors in
the field.