By Devanshi Dewan & Rashmi Mabiyan
Mumbai: The pharmaceutical industry is one of the largest sectors in India when it comes to transforming healthcare and making it more accessible to the world. It is pertinent to upgrade our quality standards that apply to the pharma industry, where quality is fundamental as primarily it is about the health of the people, informed leaders at the 4th edition of the REPharma Summit in an invigorating panel discussion titled “Quality Metrics Transforming Pharma Manufacturing Practices.”
The eminent panellists discussed the significance of quality metrics that are at play during the manufacturing process of pharmaceuticals and the role of standards in assessing competency.
The panel consisted of industry leaders namely, Shital Pathak, Sr VP – Head Analytical R&D ( Formulations), Glenmark; Dr M Damodharan, Chief Quality Officer, Sai Life Sciences Limited; Alok Mehrotra, Chief Quality Officer, Syngene International Limited and Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance as moderator.
Beginning the panel discussion, Jain highlighted, “We have the vision that we should be the volume leader, as far as 2030 is concerned. If we achieve sales of 1.2 billion dollars, we have to also achieve a prediction value. We are third largest in volume, which means the price realisation of our products have to be upgraded.”
He continued, “Unless the systems and structures are put in place, the changes on the ground do not take place. Quality metrics are very important in transforming the pharma industry because unless you have got a meta mindset, you cannot bring about transformation.”
Taking the conversation forward, Pathak spoke about the role of R&D involvement in the pharma manufacturing process and talked about the various challenges that surround quality metrics in the pharma manufacturing process.
He also added, “If we look at the current scenario, we ensure the quality efficacy and safety of the products through cGMP compliance, but it really does not give us much opportunity to look for areas of improvement. So, that is where I think the quality matrixes are going to play a major role. Another important thing here is simply patient safety and customer satisfaction.”
Furthering the discussion on quality metrics, Dr Damodharan stated, “Quality metrics is not a rocket science. It started because we thought there was going to be something positive. The vision actually improved with liquidation, safety activities being eliminated.”
Talking about the data and technological aspects involved in measuring the quality metrics in the manufacturing process, Mehrotra discussed about cause analysis and proclaimed how quality metrics are an important aspect of the manufacturing process.
He explained, “When we get a deviation before a failure happens, the next logical step is to look for a good cause analysis. So once we have the root cause, we look at minimising deviations, raising the bar on a single variable to find. As part of our MFI processes, we are supposed to review our data, at least on an annual basis. We then have a cross-industry comparison to come up with very robust processes that minimise patient risk. Having a documented formal process of risk assessment and remediation is what agencies are looking for. As technology evolves, we need to have people who are trained at the competency level. Once training becomes structured, the culture starts to change.”
While concluding the panel discussion, Jain emphasised how documentation becomes important in the manufacturing process. He also mentioned the role technology and facilities play in the quality metrics in the pharmaceutical manufacturing processes.
