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SHREE S. K. PATEL COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH GANPAT UNIVERSITY INDUSTRIAL VISIT TO SPENSUS PHARMACEUTICALS LTD
Organizers |
Faculty of Pharmacy |
Participants |
15 |
Contact No. |
|
Start Date |
11/04/2025 09:00 AM |
End Date |
11/04/2025 04:30 PM |
Venue |
Industrial Visit to Spensus Pharmaceuticals Ltd, Mehsana |
Social Media Share |
Description
SHREE S. K. PATEL COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH
GANPAT UNIVERSITY
INDUSTRIAL VISIT TO SPENSUS PHARMACEUTICALS LTD
Subject: Industrial Visit to Spensus Pharmaceuticals Ltd, Mehsana
Participants: Faculty (04) & M Pharm PQA students (15)
Date: 11/04/2025
Department of Pharmaceutical Quality Assurance, Shree S. K. Patel College of Pharmaceutical Education & Research, Ganpat University planned an Industrial Visit to Spensus Pharmaceuticals Ltd., Mehsana for M. Pharm. Pharmaceutical Quality Assurance students on 11th April, 2025. Total 04 faculty members and 15 M. Pharm students were visited the company. The visit was organized to bridge the gap between theoretical knowledge and real-world practices in the pharmaceutical sector.
Objective of the Visit
- The primary objectives of the visit were:
- To understand the functioning of a pharmaceutical manufacturing unit.
- To learn about various departments and their roles in drug development.
- To observe and analyze the production processes, quality control, and packaging techniques.
- To gain insight into the regulatory and safety standards followed in the industry.
The visit was started with the welcome of faculty members and students by the team of Spensus including Mr. Harshad Patel, Plant Head., Mr. Dilip Prajapati, QA Head., Mr. Sushil Patel, QC Head and Dr. Nilesh Patel, Director, Spensus Pharma. Ltd. The team explained the basic overview of the company with different department and operations.
Production Department Visit
The entry door for raw materials and man is different to avoid contamination, there are reverse laminar air flow and there are different exit doors for materials. All the raw materials were stored there, checked, weighed on weighing machine and sampling was done there. They have different room for the materials to be stored at cool conditions, the area was neat, hygienic and clean. There is a fridge which stored material at 2 to 8 degree Celsius and a refrigerator which stores raw materials below -25 degree Celsius. Vacuum cleaning of material is also done there. Mr. Dilip Prajapati, QA Head have explained all the labelling and storage conditions of the raw material in detail. There are 3 different types of labels used for raw material. White label for quarantine material, yellow for under test and green for approved material. Hygrometer is used to maintain temperature and humidity.
The dispensing room is where the flow of materials from the warehouse occurs, including excipients, raw materials, solvents, and color materials. In the production department, there is a planned layout at the entrance of the company, where QA Head has introduced students to the materials that come from the dispensing room through a dynamic pass box. The production area also contains a tools room and a quarantine room for in-process materials.
Tablet manufacturing involves using a tablet press machine, alongside an auto coater for tablet coating. There is a visual inspection room designated for coated tablets, as well as a quarantine area for finished products. Different packaging methods are utilized depending on the product, such as a pouch packing machine that utilizes fin seal packaging, and a precision balance is used to ensure the correct weight of each package. Finally, there is a finished store for completed products. Overall, the production area in a pharmaceutical facility is designed as a GMP-compliant, segregated space where various unit operations involved in tablet manufacturing are carried out.
QC/QA Department Visit
Mr. Sushil Patel has introduced students to the Quality Control (QC) area, where products and raw materials are tested using HPLC, UV-spectrophotometry, and infrared spectroscopy. Students learn the working principles and procedures for analyzing products and checking solvent limits, with all instruments calibrated every six months. The QC area includes equipment for dissolution testing, pH measurement, and friability testing, as well as a physicochemical room with essential equipment like hot air ovens and water baths. Additionally, there are designated stability rooms for long-term (25°C/60% RH), accelerated (40°C/75% RH), and intermediate (30°C/65% RH) stability testing, equipped with walk-in stability chambers, data loggers, and alarms for monitoring deviations. Documentation includes stability protocols, reports, and chamber qualification records.
The visit was concluded with thanks to Dilip Prajapati, QA Head; Sushil Patel, QC Head; Harshad Patel, Plant Head; and Nilesh Patel, Director of Spensus Pharma, for their invaluable contributions during the overall visit.
This experience has been invaluable as it gave us insight into how industries operate and helped us identify the connections between our academic knowledge and practical applications as Pharmaceutical Quality Assurance faculty and students. We gained a better understanding of how documentation is performed in accordance with regulatory guidelines.