NAVIGATING GLOBAL COMPLIANCE IN PHARMA TO ENSURE QUALITY AND SUSTAINABILITY

Having an inspirational approach to lead, Dr. Birendra brings over two decades of experience across pharma and healthcare industry. He has a proven track record of excellence and is recognized for setting strategies of quality cultural transformations to achieve global compliance along with sustained growth. Currently, he is in a strategic role in Global Quality, Pharmacovigilance, IT Compliance at Mankind Group. Prior to this, he is known to have led global transformation programs & initiatives in Cipla, Torrent, Zydus, Intas and Mankind at enterprise level.

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Dr. Birendra Singh, President & Global Quality Head, Mankind Pharma

In an exclusive interaction with Mandvi Singh, Managing Editor, siliconindia, Dr. Birendra Singh, President & Global Quality Head, Mankind Pharma Ltd. sheds light on 'Navigating Global Compliance in Pharma to Ensure Quality and Sustainability'

How can pharmaceutical companies establish and maintain robust data integrity practices to ensure regulatory compliance and product quality throughout drug development and manufacturing processes?

Data integrity is essential in the pharmaceutical industry, ensuring the quality, safety, and efficacy of drugs. Since medications can have both beneficial and harmful effects, it's crucial that they meet high standards throughout their lifecycle, including development, manufacturing, and discontinuation. Accurate documentation during product development is vital to avoid the release of unsafe or ineffective products.

Effective technology transfer is necessary for sharing knowledge between development and manufacturing, which should be well-documented for future reference, including corrective actions. Maintaining data integrity during commercialization is critical as each batch can affect thousands of patients, and any breaches can jeopardize safety.

Regulatory agencies like the US FDA and WHO stress the importance of data integrity, leading to published guidelines. Organizations should define clear standard operating procedures (SOPs) that comply with these guidelines and ensure personnel at all levels understand their importance through training. Promoting a "speak-up" culture encourages reporting of any integrity breaches.