By Prabhat Prakash & Prarthana Sharma
Hyderabad: Electronic batch records (EBR) are transforming the management of documentation and drug production by pharmaceutical companies. For the pharma industry, precision, compliance, and efficiency are paramount, EBRs are a leap ahead from from traditional paper-based processes to a streamlined, digital approach.
By digitising batch records, organisations can ensure real-time data accuracy, reduce human error risks, and enhance regulatory standards compliance. EBRs provide transparency and traceability in the manufacturing process that helps ensure product quality and patient safety.
The second edition of ETPharma’s Next-Gen LabCon curated a discussion on ‘Upscaling to Electronic Batch Records: Lessons from a Pharmaceutical Manufacturer’, addressing the challenges and opportunities of EBRs upscaling. The participants for the discussion were Dr Pavan Bhat, Executive Director, Natco Pharma, and Sandeep Raktate, President, India & Ireland Operations, Amneal Pharmaceuticals. The session was moderated by Vikas Dandekar, Eiditor, ETPharma.
The discussion centred around the challenges and opportunities of upscaling to electronic batch records in the pharmaceutical industry. The discussions focused on the importance of digital transformation in the industry, including the potential benefits of cost efficiency, agility, and skill set improvement, as well as the need for companies to adopt ESG practices and embrace sustainability. Dr Bhat said, “As we flow to core manufacturing, focussing on digital transformation and automation is vital. Digital answers ought to be tailored to every organisation, even as automation drives efficiency and value financial savings. Transitioning to digital batch records is critical for better record integrity and regulatory compliance. Implementing MES structures, though complex, is necessary for actual-time data and analytics. Effective digital answers must enhance value, productivity, best, and sustainability through 20-30 per cent.”
The speed of digital adoption is driven more by proactive management and strategic planning rather than by reactive responses to immediate needs, Raktate said, “CDMO groups ought to speedily adapt to client wishes to be competitive, be quicker in adoption of recent technologies. In evaluation, corporations inside the regular drug enterprise are probably slower to trade. For instance, European markets are pushing for sustainability, including mandates for going paperless due to ESG requirements. In India, at the same time as ESG adoption is growing, there is a digital divide amongst businesses.”Commenting on how greenfield opportunity in CDMO is worth pursuing due to the added advantage of integrating superior technology, Dr Bhat added, “If you’ve got a greenfield opportunity in CDMO, it is well worth pursuing because it lets you construct contemporary, green structures from the start, integrating superior technology and the Internet of Things (IoT) without the want for retrofitting. This is especially valuable as CDMO partners from the US and Europe are drawn to India’s cost performance, agility and skill set. As CDMOs operations increasingly have more awareness of data analytics, having a greenfield setup positions you to leverage those advancements correctly.”
Raktate stated, “India’s regulatory bodies, which include Schedule M and CDSCO, are striving to seize up with worldwide standards, however face demanding situations due to the legacy structures and the potential effect on numerous industries. The shift towards digitalisation is underway, in particular among larger companies, although it comes with initial excessive fees and time investments.”
Raktate mentioned that for greenfield initiatives, beginning with a fully electronic system is right. Transitioning from paper to electronic simplifies documentation, reduces errors, and enhances audit efficiency. Electronic structures streamline information tracking and offer real-time indicators, improving reaction instances and factual integrity as compared to cumbersome paper data.
“Adopting virtual solutions allows us to live in advance of regulatory modifications and build acceptance as true with auditors. Digital systems ensure statistics integrity, and compliance with standards like 21 CFR and streamline audit approaches by presenting correct, real-time information. Building confidence from day one with these structures could make regulatory bodies smoother and more efficient,” stated Dr Bhat.
Digitalisation and AI cannot replace human judgement and the need for thorough investigations. Digital structures cannot eliminate human mistakes, they can help save troubles associated with facts integrity and manipulation. Raktate stated, “Transitioning to electronic systems is useful, as it reduces the threat of problems related to paper-based total statistics and lets in for better coping with capacity troubles. Starting with a robust digital method helps avoid sizable complications and builds self-belief within the gadget.”
The positive shift in the Indian pharmaceutical industry, as evidenced by the aid of a decrease in observations, audits, and inspections, the reductions indicating upgrades in regulatory compliance and pleasant standards, bringing India in the direction of international benchmarks. However, the trend is dynamic and subject to change, so ongoing interest in satisfaction and compliance is essential to sustaining this progress.
Dr Bhat concluded, “For an effective IT and IoT integration, it is critical to design a necessary solution in which all components are interconnected seamlessly. This ensures statistics flow smoothly throughout one-of-a-kind structures and vendors, creating a cohesive community. While setting this up is less complicated in a greenfield state of affairs, integrating into present surroundings with multiple programmes and ERP systems is extra complicated but feasible with certain expert evaluations. This method prevents redundant information access and guarantees green operation.”
The experts concluded that upscaling to digital batch facts (EBR) underscores its transformative effect on the pharmaceutical industry by enhancing accuracy and lowering the want for rigorous inspections.
