Name: Shristi Khadgi
Role: Quality Assurance Officer at Tismor Health and Wellness
Before starting the GMP course, I aimed to strengthen my understanding of Good Manufacturing Practice (GMP) principles and enhance my ability to critically assess real-world industrial issues in the pharmaceutical industry. I also wanted to gain deeper insight into the manufacturing processes of pharmaceutical dosage forms and develop a clearer understanding of the regulatory requirements necessary to ensure product quality and compliance.
One specific instance where the course made a meaningful impact was when I identified an artwork discrepancy between a Packaging Work Order (PWO) and the actual product label during IPQA checks. Drawing on what I had learned, I understood that all documentation must align precisely with the approved artwork and the validated manufacturing and packaging processes. When I noticed that the PWO and label did not match, I recognised this as a deviation from GMP requirements.
As it was not feasible to immediately revise the PWO, I initiated a Change Control to formally correct the document. In addition, we raised a planned deviation to permit a controlled hand amendment of the artwork number. During the hand amendment process, we referenced both the Change Control (CC) numbers and Quality Deviation Report (QDR) numbers, ensuring all updates were appropriately documented with signatures and dates to maintain full traceability. The GMP course emphasised that initiating a Change Control is the first and most critical step whenever modifying a process, document, or equipment. This ensures proper documentation history, transparency, and traceability.
The group discussion sessions, particularly those based on real-world scenarios, were among the most valuable aspects of the course for me. They provided the opportunity to engage with peers, exchange perspectives, and analyse GMP-related situations collaboratively. This enriched the learning experience, broadened my understanding, and exposed me to different approaches to addressing the same problem. Presenting my viewpoints and receiving constructive feedback from lecturers further strengthened my critical thinking skills and deepened my understanding of GMP principles.
Since completing the course, I have noticed a significant shift in how I approach my work. I now evaluate tasks and decisions through the lens of product quality and patient safety. I consistently assess whether processes meet defined criteria, adhere to approved procedures, and align with regulatory requirements. The course has also reinforced the importance of continuous improvement in maintaining compliance and operational excellence.
I would highly recommend this course to anyone interested in pursuing a career in quality within the pharmaceutical or food industries. The GMP program provides a comprehensive understanding of key regulatory authorities such as the TGA, FDA, and EMA, and explains how their requirements strengthen industry practices. It also delivers practical guidance on maintaining product quality and ensuring patient safety. Most importantly, it builds the confidence to make compliant, well-informed decisions within a regulated environment.
