Introduction:
The
pharmaceutical industry plays a crucial role in human health and well-being,
developing and supplying life-saving medications. To ensure the safety and
efficacy of these products, stringent quality control (Q.C.), quality assurance
(Q.A.), and research and development (R.D.) processes are essential. However,
keeping pace with evolving regulations and technologies demands a skilled
workforce trained in advanced Q.C., Q.A., and R.D. techniques. The Department
has signed Memorandum of understanding with Insta Vision Laboratory Satara to
provide such kind of skills to the students. Under this MOU, Insta Vision
Laboratory has agreed to provide a twenty one day Industrial Training Programme
on ‘Advance QC, QA, & R&D Techniques in Pharmaceutical Industry’
for Post Graduate (M.Sc.) students. This report provides an overview of an industrial
skill training program.
Training Methodology:
The
training program adopted a blended learning approach, combining theoretical
sessions, practical demonstrations, case studies, and hands-on exercises.
Industry experts, regulatory affairs professionals, and experienced researchers
have served as trainers, providing participants with real-world insights and
best practices.
Basic Understanding for Theoretical
Concepts During Course:
•
API and Formulation Industry work flow
•
Functions and working in QC QA and Regulatory Affairs
•
GMP, GLP, GDocP, 21 CFR part 11 & Data Integrity
•
Calibration, Validation, Qualification
•
QC Sections Working (RM, PM, FP)
•
Lab-Chemicals, Glassware's, Standards, Lab Safety
•
Spectroscopic and Chromatographic Analytical Techniques ( HPLC, UV, IR, GC)
•
Failure Investigation-OOS/OOT and Deviations, QMS- Change Control, CAPA, RCI
•
Pharmacopeia and Regulatory Authorities
Instruments Handled During Training:
§ HPLC
(Shimadzu LC 2010 C; Chromeleon 6.8 SR 11)
§ UV-Spectrophotometer
(Shimadzu; UV-1800)
§ Dissolution
Test Apparatus (Lab india ; DS8000)
§ Disintegration
Test Apparatus (Electrolab; ED-2SAPO)
§ Analytical
Balance-Operation and Calibration (Aczet, CY224)
§ pH
meter - Operation and Calibration (Hanna; HI 2211 )
§ Friability
test apparatus (Electrolab, USPXXIII)
§ Hardness
tester (Scientech: SE-276(A))
§ Digital
Vernier caliper (Emtex Engineering)
§ Karl
Fischer apparatus (Veego, Matic-D)
§ Digital
Density Meter (Anton Paar, DMA 38)
§ Digital
Melting Point Apparatus (Lab India: MR-VIS) Tap Density Apparatus (Electrolab,
ETD-1020)
Duration and Certification:
The program was designed to be conducted over a specified duration, ensuring comprehensive coverage of the training skills. This training program was conducted during 15/04/2023 to15/05/2023 period. Participants who successfully completed the training were awarded a certification, recognizing their enhanced skills in Q.C., Q.A., and R.D. techniques in the pharmaceutical industry.
Total
Number of participated students: 23
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