AI can detect anomalies during production: Bharat Shah

  • Interviews
  • Oct 24,24
In this exclusive interview with Sanskriti Ramachandran, Bharat Shah of SK Healthcare, delves into the role of ai and automation in the pharma industry.
AI can detect anomalies during production: Bharat Shah

Automation has already replaced many manual processes that were prone to human error, improving the consistency and reliability of QC procedures. AI takes this a step further by enabling real-time monitoring and predictive analytics, says Bharat Shah, MD, SK Healthcare.

What is the importance of quality control in pharma?
   Quality control (QC) is a critical aspect of the pharmaceutical industry because it ensures that drugs are safe, effective, and meet stringent regulatory standards. Every drug that reaches the consumer must go through rigorous testing to guarantee it is free from contamination, properly formulated, and stable. Without QC, there is a significant risk of substandard or harmful products reaching patients, which can lead to severe health consequences. The role of QC extends to compliance with regulatory requirements from agencies like the FDA, EMA, or CDSCO. These agencies set benchmarks that ensure manufacturing processes meet Good Manufacturing Practices (GMP) to maintain consistency in drug production. QC also plays an essential role in protecting the reputation of pharmaceutical companies. A robust QC system assures patients, healthcare professionals, and regulators that a company's products can be trusted, reducing the likelihood of recalls or legal liabilities, which can be financially and reputationally damaging.
 
What role do you see AI/automation playing in quality control and assurance?
   AI and automation are revolutionising quality control and assurance processes within the pharmaceutical industry by enhancing efficiency, precision, and compliance. Automation has already replaced many manual processes that were prone to human error, improving the consistency and reliability of QC procedures. AI takes this a step further by enabling real-time monitoring and predictive analytics. For instance, AI algorithms can detect anomalies during the production process, allowing for swift corrective actions that prevent the release of defective products. Automation systems handle tasks like raw material sampling and in-process testing with a level of precision and speed that is impossible for human operators. Additionally, AI can analyse large datasets from the production floor to predict equipment failures or quality issues before they arise, thus minimising downtime and improving overall production efficiency. These technologies also streamline compliance reporting by automating the collection and analysis of data required for regulatory submissions, reducing the time and effort needed for audits.
 
How is your company ensuring quality control in your production?
   Our company has integrated a sophisticated blend of traditional QC techniques and advanced technologies to maintain the highest level of product quality throughout the production lifecycle. We use fully automated systems to oversee critical stages of manufacturing, from dosing to packaging, ensuring precision and consistency in every batch we produce. In addition to automation, we have implemented AI-driven tools to monitor production processes in real-time, allowing us to detect and address any deviations or potential quality issues instantly. This approach not only ensures compliance with regulatory standards but also minimises the risk of errors that could compromise product quality. We also employ a digital Quality Management System (QMS), powered by AI that centralises all quality-related data. This system enhances traceability and ensures that all processes are fully documented, making audits by regulatory bodies more efficient. Furthermore, by using predictive analytics, we can anticipate potential risks in production and implement corrective measures proactively, which not only safeguards product quality but also enhances operational efficiency by reducing wastage and preventing downtime. This combination of automation, AI, and traditional QC practices ensures that our products consistently meet the highest industry standards.

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