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, Pharma covigilance, 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.
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.
Following policy establishment, governance focuses on compliance through departmental reviews and real-time quality audits to prevent breaches. With Industry 4.0 advancements, pharmaceutical companies are increasingly automating processes to enhance compliance with data integrity.
How can Good Manufacturing Practices (GMP) be effectively integrated into daily operations to uphold product consistency, proper documentation, and quality control standards?
Following Good Manufacturing Practices (GMP) is essential for ensuring consistent product quality in drug manufacturing. GMP provides guidance on personnel qualifications, facility and equipment requirements, material management, production controls, quality checks, validation, and more.
Organizations can adopt a risk-based approach using Quality Risk Management (ICH Q9) to align their policies with GMP guidelines, emphasizing that quality is the responsibility of all employees. Regular training in GMP is crucial, and documentation should be clear and accessible, possibly in local languages. In-process quality checks and Quality Release tests ensure consistent product quality, while Continuous Process Verification promotes ongoing quality assurance. Internal audits serve as a governance tool to identify issues and implement corrective actions.
How can sustainability be embedded into pharmaceutical compliance practices, including sustainable sourcing, waste management, energy efficiency, and eco-friendly packaging design?
Significant advancements in ESG sustainability are becoming a social and regulatory responsibility for all organizations, including the pharmaceutical industry. To meet these obligations, the industry is focusing on reducing paper usage through simplified documentation and automated, paperless manufacturing processes.
To minimize waste, manufacturing should optimize solvent use and enhance handling procedures for rejected materials, allowing for reprocessing instead of destruction. Energy efficiency can be improved by utilizing alternative fuels, such as biomass, for boilers and exploring renewable energy sources like solar power. Additionally, packaging materials should be redesigned to decrease paper and plastic use through compact designs. Collaboration between the engineering and pharmaceutical industries can lead to the development of machinery that minimizes waste and employs biodegradable or bulk packaging solutions. Ultimately, the Quality Unit can serve as a change agent in implementing ESG initiatives while ensuring product quality and regulatory compliance.
What best practices should companies adopt to prepare for regulatory audits, manage audit findings, and demonstrate a commitment to patient safety and continuous improvement in quality standards?
To achieve success, it’s crucial to be consistently prepared for inspections. This involves adhering to regulatory requirements, following written procedures, and ensuring comprehensive documentation right from the start of any activity, aligned with Data Integrity principles (ALCOA++). All manufacturing and testing records must be reviewed before a batch is released, and QMS documentation should be kept updated. Periodic reviews at all organizational levels, including top management, are necessary to maintain the manufacturing site's health.
Even with strict adherence to systems and procedures, inspectional observations may occur. In such cases, voluntarily offering a Corrective and Preventive Action (CAPA) plan during the inspection can be beneficial if accepted by the inspector. If not accepted, the observation will be included in the inspection report.
When responding to inspectional observations, it's important to thoroughly analyze the cited issues, consider the background, and develop a comprehensive CAPA that extends beyond the cited observation. Conduct an impact assessment related to product quality and patient safety, including additional testing if necessary. Responses to the regulatory agency must be timely and, although not all CAPAs need to be completed beforehand, they should demonstrate a holistic approach with justifiable timelines for implementation. Periodic follow-ups on CAPA progress are also recommended.
According to GMP guidelines, self-inspections or internal audits should be conducted to ensure compliance and drive continuous improvement in the quality system and product quality. Regulatory inspections can also reveal potential areas for enhancement and should be treated as opportunities for growth, especially regarding critical issues like data Integrity to mitigate patient safety risks and protect business interests.
How is India contributing to the global bioeconomy, and what key innovations in biotech are driving the country’s influence on international markets?
India is one of the fastest-growing major economies globally, ranked 5th in GDP. The country excels in various sectors, including infrastructure, research, and pharmaceuticals, earning the title ‘Pharmacy of the World’ during the COVID-19 pandemic as a significant exporter of vaccines and generic medicines. To sustain this growth, innovation and resource optimization in production are crucial.
India is also contributing to the global bioeconomy by advancing renewable energy through solar, wind, hydro, and biomass, achieving a record ethanol blending rate of nearly 20 percent. Efforts to reduce plastic use, promote recycling, and utilize plastic in road construction are ongoing.
The pharmaceutical industry is focusing on Research and Development to enhance manufacturing efficiency by adopting new, non-destructive technologies, like Process Analytical Technology (PAT). The Government of India has allocated Rs. 2300 cr. for the Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) program to support biotech research, indicating progress but emphasizing the need for continuous improvement.
The Union Budget 2025 introduced several reforms. How do you think the inlaid provisions will shape the growth of India’s pharmaceutical sector with further policy changes driving innovation and global competitiveness?
India, known as the ‘Pharmacy of the World’, is a major exporter of generic drugs. However, the pandemic highlighted challenges, such as our reliance on imports from countries like China for raw materials and active pharmaceutical ingredients (APIs). In response, the Government of India launched the Production Linked Incentive (PLI) Scheme for the Pharmaceutical Industry in 2020 to promote self-reliance under the Atmanirbhar Bharat.
In the Union Budget for 2025, Rs.2445 crore has been allocated for the PLI Scheme, a 14 percent increase from the previous year. Additionally, Rs.1615 crore is set aside for the Development of the Pharmaceutical Industry, reflecting a 25 percent rise. The budget exempts customs duty on 36 life-saving drugs for cancer patients and rare disease sufferers and offers tax exemptions for bulk drugs used in their manufacture.
To enhance medical education, 10,000 new seats will be added to medical colleges over the next five years, and Rs.20,000 crore is designated for research and medical tourism under the 'Heal in India' campaign. Various programs aim to provide medical care to the poorest citizens of India. Overall, the Union Budget for 2025 presents a positive outlook, focused on strengthening the pharmaceutical industry, supporting patients, and achieving the goals of Atmanirbhar Bharat.
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.
Following policy establishment, governance focuses on compliance through departmental reviews and real-time quality audits to prevent breaches. With Industry 4.0 advancements, pharmaceutical companies are increasingly automating processes to enhance compliance with data integrity.
How can Good Manufacturing Practices (GMP) be effectively integrated into daily operations to uphold product consistency, proper documentation, and quality control standards?
Following Good Manufacturing Practices (GMP) is essential for ensuring consistent product quality in drug manufacturing. GMP provides guidance on personnel qualifications, facility and equipment requirements, material management, production controls, quality checks, validation, and more.
Organizations can adopt a risk-based approach using Quality Risk Management (ICH Q9) to align their policies with GMP guidelines, emphasizing that quality is the responsibility of all employees. Regular training in GMP is crucial, and documentation should be clear and accessible, possibly in local languages. In-process quality checks and Quality Release tests ensure consistent product quality, while Continuous Process Verification promotes ongoing quality assurance. Internal audits serve as a governance tool to identify issues and implement corrective actions.
How can sustainability be embedded into pharmaceutical compliance practices, including sustainable sourcing, waste management, energy efficiency, and eco-friendly packaging design?
Significant advancements in ESG sustainability are becoming a social and regulatory responsibility for all organizations, including the pharmaceutical industry. To meet these obligations, the industry is focusing on reducing paper usage through simplified documentation and automated, paperless manufacturing processes.
To minimize waste, manufacturing should optimize solvent use and enhance handling procedures for rejected materials, allowing for reprocessing instead of destruction. Energy efficiency can be improved by utilizing alternative fuels, such as biomass, for boilers and exploring renewable energy sources like solar power. Additionally, packaging materials should be redesigned to decrease paper and plastic use through compact designs. Collaboration between the engineering and pharmaceutical industries can lead to the development of machinery that minimizes waste and employs biodegradable or bulk packaging solutions. Ultimately, the Quality Unit can serve as a change agent in implementing ESG initiatives while ensuring product quality and regulatory compliance.
What best practices should companies adopt to prepare for regulatory audits, manage audit findings, and demonstrate a commitment to patient safety and continuous improvement in quality standards?
To achieve success, it’s crucial to be consistently prepared for inspections. This involves adhering to regulatory requirements, following written procedures, and ensuring comprehensive documentation right from the start of any activity, aligned with Data Integrity principles (ALCOA++). All manufacturing and testing records must be reviewed before a batch is released, and QMS documentation should be kept updated. Periodic reviews at all organizational levels, including top management, are necessary to maintain the manufacturing site's health.
Even with strict adherence to systems and procedures, inspectional observations may occur. In such cases, voluntarily offering a Corrective and Preventive Action (CAPA) plan during the inspection can be beneficial if accepted by the inspector. If not accepted, the observation will be included in the inspection report.
When responding to inspectional observations, it's important to thoroughly analyze the cited issues, consider the background, and develop a comprehensive CAPA that extends beyond the cited observation. Conduct an impact assessment related to product quality and patient safety, including additional testing if necessary. Responses to the regulatory agency must be timely and, although not all CAPAs need to be completed beforehand, they should demonstrate a holistic approach with justifiable timelines for implementation. Periodic follow-ups on CAPA progress are also recommended.
According to GMP guidelines, self-inspections or internal audits should be conducted to ensure compliance and drive continuous improvement in the quality system and product quality. Regulatory inspections can also reveal potential areas for enhancement and should be treated as opportunities for growth, especially regarding critical issues like data Integrity to mitigate patient safety risks and protect business interests.
How is India contributing to the global bioeconomy, and what key innovations in biotech are driving the country’s influence on international markets?
India is one of the fastest-growing major economies globally, ranked 5th in GDP. The country excels in various sectors, including infrastructure, research, and pharmaceuticals, earning the title ‘Pharmacy of the World’ during the COVID-19 pandemic as a significant exporter of vaccines and generic medicines. To sustain this growth, innovation and resource optimization in production are crucial.
India is also contributing to the global bioeconomy by advancing renewable energy through solar, wind, hydro, and biomass, achieving a record ethanol blending rate of nearly 20 percent. Efforts to reduce plastic use, promote recycling, and utilize plastic in road construction are ongoing.
The pharmaceutical industry is focusing on Research and Development to enhance manufacturing efficiency by adopting new, non-destructive technologies, like Process Analytical Technology (PAT). The Government of India has allocated Rs. 2300 cr. for the Biotechnology Research Innovation and Entrepreneurship Development (Bio-RIDE) program to support biotech research, indicating progress but emphasizing the need for continuous improvement.
The Union Budget 2025 introduced several reforms. How do you think the inlaid provisions will shape the growth of India’s pharmaceutical sector with further policy changes driving innovation and global competitiveness?
India, known as the ‘Pharmacy of the World’, is a major exporter of generic drugs. However, the pandemic highlighted challenges, such as our reliance on imports from countries like China for raw materials and active pharmaceutical ingredients (APIs). In response, the Government of India launched the Production Linked Incentive (PLI) Scheme for the Pharmaceutical Industry in 2020 to promote self-reliance under the Atmanirbhar Bharat.
In the Union Budget for 2025, Rs.2445 crore has been allocated for the PLI Scheme, a 14 percent increase from the previous year. Additionally, Rs.1615 crore is set aside for the Development of the Pharmaceutical Industry, reflecting a 25 percent rise. The budget exempts customs duty on 36 life-saving drugs for cancer patients and rare disease sufferers and offers tax exemptions for bulk drugs used in their manufacture.
To enhance medical education, 10,000 new seats will be added to medical colleges over the next five years, and Rs.20,000 crore is designated for research and medical tourism under the 'Heal in India' campaign. Various programs aim to provide medical care to the poorest citizens of India. Overall, the Union Budget for 2025 presents a positive outlook, focused on strengthening the pharmaceutical industry, supporting patients, and achieving the goals of Atmanirbhar Bharat.
