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Biocon  /  Businesses  /  Biosimilars  /  Quality & Compliance

BIOCON BIOLOGICS

Quality & Compliance

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At Biocon Biologics, adherence to the highest quality and compliance standards is one of our core values and we strive to achieve it consistently across all functions associated with Research and Development, Manufacturing, Testing, Release, and Distribution of our biosimilar products. Our Quality Management System is supported by comprehensive procedures and protocols aligned with Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Distribution Practice (GDP), Good Documentation Practice and Good Pharmacovigilance Practice (GVP), to ensure high standards of quality consistently.

A strong, well-trained Quality team monitors every step of the development and manufacturing process to ensure every product complies with internationally accepted good practices and standards of quality, purity, efficacy and safety. Our Quality Control and Quality Assurance teams ensure compliance with cGMPs to deliver high-quality products consistently

Biocon Biologics’ manufacturing facilities, located across Bangalore in India and Johor in Malaysia, have received over 25 cGMP approvals from international regulatory agencies.

Excellence Through Digital Transformation

We are continuously looking at ways to strengthen our quality culture and improve our systems and processes to best-in-class regulatory standards. Digitization is a critical part of our strategy and plays an important role in ensuring consistency of quality and process efficiency.

Biocon Biologics has drawn on the latest global technology trends in the health and life sciences industry to deploy digital initiatives to enhance quality and compliance.

Our Center of Excellence (Quality Systems Digital Transformation & Operation Excellence) has enabled the identification and execution of digital and process solutions through structured root cause analysis. The vision of the CoE is to transform the quality culture of Biocon Group through the adoption of Lean Six Sigma Principles to enable continuous innovation, consistent right-first-time delivery, enhanced efficiency, productivity and agility.

The CoE is developing an overarching operational excellence framework through the deployment of digital solutions to enhance quality and compliance, augment productivity, enable data integrity. It will create an enterprise where everybody works unitedly to build higher standards of governance and deliver greater levels of trust to all our stakeholders.

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Facilities Approved By Key International Regulatory Agencies
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U.S. FDA
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EMA
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Central Drugs Standard Control Organisation, India
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PMDA, Japan
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Health Canada
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COFEPRIS, Mexico
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ANVISA, Brazil
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MCC, South Africa
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Ministry of Health, Turkey
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Ministry of Health, Iran
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Ministry of Health, Russia
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NPRA, Ministry of Health, Malaysia
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Ministry of Food and Drug Safety (MFDS), South Korea
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TGA, Australia
CORPORATE GOVERNANCE
KEY THERAPEUTIC AREAS
RESEARCH SERVICES
OUR CULTURE
RESPONSIBILITY
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