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Quality Management

At Syngene, quality is of paramount importance and comes even before business profits. We have earned a remarkable reputation for ourselves among clients and regulatory agencies for our quality culture across the organization. Syngene’s quality department is involved at every stage of a drug’s life cycle — safety assessment, development and manufacturing of drugs and clinical development. Driven by the corporate quality team, it makes use of individual quality teams to ensure compliance with good laboratory practices (GLP), good manufacturing practices (GMP) and good clinical practices (GCP).

Our quality management system (QMS)

We strongly believe and emphasize on the phase and business model appropriate quality management system (QMS), meeting the essential regulatory requirement. Our QMS focuses on continual improvements by adopting technological advances and keeping in line with various regulatory requirements. Automated quality management systems like Track-wise system, learning management system (LMS), laboratory management system (LIMS), document management system (DMS) are in place for smooth compliance as per various regulatory standards.

The principles of the quality management system adopted by the company are as per the standards/ guidelines given below:

  • GMP as per schedule–M of Drugs and Cosmetics Act (India)
  • ICH series guidelines
  • EU-GMP
  • Japan GMP
  • 21 CFR parts 11, 210, 211, 620 and 820
  •  OECD guidelines
  • New drugs and clinical trials rules, 2019
  • ISO 9001:2015
  • ISO 13485:2016

Quality policy

Syngene is committed to offering various scientific research and development services that meet or exceed client expectations. All our services are in compliance with national and international regulatory requirements. We achieve this by:

  • Integrating and aligning quality into 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 with applicable national and international regulations and standards
  • Focusing on fostering a culture of continuous quality improvement
  • Fostering an environment of a quality compliant culture
  • Recognizing and rewarding excellence in quality
  • Ensuring integrity in generating and presenting data
  • Providing continuous education on GXP requirements
  • Integrating hygiene and quality

Corporate quality assurance

A well experienced team of corporate quality assurance is in place to ensure implementation of robust quality system across Syngene. CQA is acting as key function to implement quality policies, latest update in GMP, regulatory guidelines, guiding business unit quality team to deliver quality products in quality time.

Each site has well trained personnel for quality to implement and follow the quality system.

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. This includes:

  • Physical-chemical testing (including five batch analysis)
  • Toxicity studies
  • Mutagenicity studies
  • Analytical and clinical chemistry testing
  • Viral clearance study:
    • Services acceptable to all OECD member countries for assessment of chemicals (full adherence to MAD system)
    • Ensures strict adherence to principles of GLP during the entire course of study
    • Offers independent quality assurance unit to monitor overall activities as per GLPs
    • Offers fully functional dedicated test item/substance/article control office
    • Offers archive facility for secure storage and retention of records and materials
    • Ensures establishment of effective communication links for the sponsor to interact with study director, quality assurance and management (Syngene values the explicit and implicit duties of the sponsor)
  • Others:
    • Bioanalysis (method, development and validation)
    • Sample analysis
    • Safety pharmacology studies

Current good manufacturing practices (cGMP)

Syngene’s GMP vertical has three key functional units — quality control (QC), quality assurance (QA) and regulatory affairs (RA), each with its own responsibilities

Quality control

Quality control establishes procedures for quality control of incoming materials, in process, intermediates, API and drug products. Our state-of-the- art quality control laboratories follow all the current guidelines for monitoring strict quality standards of all our products / analytical services.

Quality assurance

Quality assurance is responsible for implementing and monitoring quality systems throughout the company. It ensures continual compliance with cGMP and regulatory requirements. It also controls all operations starting from procurement of raw materials to production and shipping of products using scientific control systems.

Regulatory affairs

Regulatory affairs (RA) is responsible for obtaining the necessary drug regulatory licenses in India as well as accreditations wherever required, from other countries in the world. RA caters to small molecule as well as biologics projects. RA authors the dossiers (investigational, marketing applications), and prepares regulatory communications (pre-IND, scientific advice, query response etc.) as and when required by the client. RA also provides strategic and chemistry, manufacturing and controls (CMC) consulting services to internal stakeholders or clients for their development programs.

Good clinical practices (GCP)

Syngene’s clinical development business group serves pharmaceutical and biotechnology companies across the globe in conducting clinical research from early-phase through late-phase clinical trials across a wide range of therapeutic areas.

Services include:

  • Phase I- bioavailability/ bioequivalence (BA/BE) studies
  • Clinical trial management
  • PK/bioanalytical (small molecules and biologics)
  • Central Laboratory
  • Integrated eClinical services
  • Clinical data management and biostatistics
  • Regulatory affairs
  • Medical monitoring
  • Pharmacovigilance
  • Medical writing

GCP Quality group comprises clinical quality assurance team, bioanalytical quality assurance team, an independent quality systems management team and quality improvement teams. Together, they are responsible for administration of quality management systems for activities undertaken by clinical development.

This is to ensure compliance with national and international regulations and guidelines mandated by various regulatory authorities. They conduct study audits and routine systems audits of various functions of clinical development operations and quality management systems including important vendor/supplier qualification and surveillance audits.

Clinical quality assurance is responsible for conducting audits BA/BE, early phase in-house healthy volunteer studies and onsite audits of clinical trial investigation sites for early and late phase studies. It is also responsible for ensuring compliance with ICH-GCP by performing audits in clinical data management and biostatistics functions. Clinical quality assurance also ensures compliance with CAP and NABL (ISO 15189) requirements in Central Laboratory.

Bioanalytical quality assurance is responsible for audits of study process, data and method validation of bioanalytical laboratory and pharmacokinetic data.

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