Putting Science to Work

Quality and Certifications

Syngene with its well experienced and integrated quality and regulatory organization provides compliance across EU and US regulations to its multi-national clients servicing Research and Development, all phases of Manufacturing (Pre-Clinical to Phase I – III) to include small and large molecules along with medical devices, nutraceuticals and other regulated products. The quality systems are implemented and monitored; where relevant, upgraded, according to current and evolving international regulations, guidelines, standards and industry best practices.

Quality and Regulatory Compliance:

Quality Policy

Syngene is committed to providing services and products that meet or exceed client’s expectations and regulatory requirements by:

  • Hiring and retaining a well experienced staff with international experience

  • Integrating and aligning quality in all our work practices

  • Adopting world class quality systems, processes and tools

  • Striving for Highest level of scientific and operational excellence with focus on quality

  • Complying to applicable national and international regulations and standards

  • Focusing on continual quality improvement

  • Fostering a quality compliant cultures

  • Recognising and rewarding excellence in quality

Corporate Quality and Regulatory Compliance

Corporate Quality and Regulatory Compliance provides Quality Management System strategy directed towards Syngene’s vision. This establishes a framework for Quality for verticals / Business Units as well as partnerships / collaborations / alliances.

Continuous improvement and harmonization of Quality Policies and Processes with integration.

Implement and upgrade Quality Management Systems to comply with applicable International Regulatory requirements and industry practices in relevant area.

Formulate enhancements and work to design, validate and implement new processes to enhance the effectiveness of QA within Syngene while identifying and communicating prioritized areas of risk collaboratively and proactively

Conduct Management Review to share quality metrics, accomplishments, challenges and resource allocations.

Our Quality Systems

  • cGMP: Manufacturing and Production

  • GLP: Non/Pre-Clinical environment, health and Safety Studies

  • GCP: Clinical Development

  • CAP and NABL (ISO 15189: Medical laboratories - Requirements for quality and competence): Central lab at Clinical Development

  • ISO 13485 - Medical devices - Quality Management Systems - Requirements for regulatory purposes: S15 Formulation Unit.

  • ISO 9001:2008 -Our Management Systems is in line as per ISO 9001:2008 standards for following scope- Contarct Services in Discovery, Develpment and Manufacturer of Chemical Molecules, Drug Products and Biopharmaceuticals.

Key Compliance
Good Laboratory Practices (GLP)

  • The GLP test facility at Syngene is certified by National GLP Compliance Monitoring Authority (NGCMA), India for conducting studies in compliance with the OECD Principles of GLP.

    • Physical-chemical studies
    • Toxicity studies
    • Mutagenicity studies
    • Others: Bio analytical (TK analysis for pre-clinical studies)

  • Services provided under this umbrella is mutually accepted by the OECD member countries for the assessment of chemicals.

  • The principles of GLP are strictly adhered during the entire course of study

  • An independent Quality Assurance Unit monitors the overall activities as per GLPs.

  • A dedicated test item/substance/article control office is established and functional.

  • Archive facility at Syngene provides a secure storage and retention of records and materials.

  • Effective communication links are established for the sponsor to interact with Study Director, Quality Assurance and Management.

Syngene values the explicit and implicit duties of the sponsor.

Current Good Manufacturing Practices (cGMP)

Syngene provides manufacturing services of APIs and intermediates, biologics, drug products as well as manufacturing and supply of clinical material under GMP standards. Our manufacturing and testing facilities are GMP certified from Indian drug regulatory authority and are in compliance with US FDA 21 CFR Part 210 and 211, ICH Q7 and EU GMP guidelines. We have extensive experience in analytical method validation, process validation and cleaning validation under GMP regulations.

We are regularly inspected by the office of the DCGI (Drugs Control General of India) (Indian FDA). We have also been inspected by a number of qualified persons, client QA and third party auditors.

  • Syngene's Quality Department has three key functional units – Quality Control, Quality Assurance and Regulatory Affairs, each with its own responsibilities:

  • Quality Control establishes procedures for quality control of incoming materials, in process, intermediates, API and Drug Products. The state of the art quality control laboratories follow all the current guidelines for monitoring strict quality of our products / analytical services.

  • Quality Assurance is responsible for implementing and monitoring of Quality Systems throughout the company. Quality Assurance ensures the continual compliance with cGMP and regulatory requirements. Quality Assurance controls all the operations starting from the procurement of raw materials to production and shipping of products with scientifically based control systems.

  • Regulatory Affairs handles both National and International Regulatory Affairs.

  • National Regulatory Affairs is responsible for licensing and compliance to all National Regulatory requirements for import, export, manufacturing, testing of drugs, biologics, agrochemicals and other products handled at Syngene.

  • International Regulatory Affairs is responsible for filing all regulatory documents to various regulatory authorities as per the requirement of the clients and addressing all regulatory queries.

Good Clinical Practices (GCP)

Syngene’s Clinical Development group supports early through late phase clinical trials across a wide range of therapeutic areas.

Services includes clinical trial management, PK/Bioanalytical - small molecules and biologics, central lab, integrated eClinical services, clinical data management and biostatistics, regulatory affairs, medical monitoring, pharmacovigilance and medical writing.

Clinical Development Quality Assurance group comprises of Clinical and Analytical Quality Assurance. They are responsible for the Quality Management Systems for the activities undertaken by Clinical Development to ensure compliance with international and national regulations and guidelines mandated by various regulatory authorities. They conduct routine system audit of the Quality Management Systems as well as vendor audits.

Clinical Quality Assurance is responsible for the conduct of study audits of the BA/BE, Phase I, II, III and IV; this also includes in-house and onsite audits of clinical trial investigation sites.

Analytical Quality Assurance is responsible for the study and process audits at the Bioanalytical Laboratory; responsible to ensure compliance with CAP and NABL (ISO 15189) requirements in Central Laboratory.

Certifications
GMP Certificate

GMP  Certificate by the Drug Controller General of India

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GMP Certificate

GMP Certificate by the Drug Controller General of India(Unit II)

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FDA – Establishment Inspection Report

FDA – Establishment Inspection Report

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GLP Certified facilities

GLP Certified facilities

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US FDA Redacted EIR

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FDA – Establishment Inspection Report

NABL Certificate

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ISO 13485: Medical devices -- Quality management systems -- Requirements for regulatory purposes

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ISO 9001 -2008 Certificate

ISO 9001 -2008 Certificate

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