Quality Assurance - Overview
Anthem Biosciences, equipped with state-of-the-art facilities, has established Quality Department to ensure current quality and international regulatory standards are practiced.Dedicated team of about 60 people are committed to provide quality products and services in all phases of the project (R&D to Manufacturing)
Quality Department has three key functional units – Quality Assurance, Quality Control (Analytical and Microbiology), and Regulatory Affairs.
Our manufacturing and testing facilitiesare in compliance to:
- US FDA CFR 210 and 211
- ICH Q7 and EU GMP guidelines
Inspection History
- Inspected by qualified persons,
- Client QA and third party auditors
- USFDA inspection awaited
Accreditation Planned (2013-2014)
- Integrated Management Systems
- ISO 9001:2008 (Quality Management Systems)
- ISO 14001:2004 (Environmental Management Systems)
- OHSAS 18001:2007 (Occupational Health and Safety Management Systems)
- AAALAC (Accreditation of the Association for Assessment and Accreditation of Laboratory Animal Care)
- OECD GLP certification by NGCMA (National GLP Compliance Monitoring Authority)
Quality Assurance
Responsible for implementation of Quality Systems in the organization.
We focus on:
We focus on:
- Developing, Implementing and continuously evolving Quality Standards
- Monitoring to ensure compliance
- Upgrading Quality Systems as per cGMP, GLP and ICH standards
- Upgrading technology standards
- Training personnel on quality aspects across various departments in the organization
- Conducting Internal audits as part of self inspection program
- Conducting Quality Reviews
- Overseeing qualification and validation activities (facility, equipment, analytical methods and process validation)
Regulatory Affairs
- Compilation and filing of regulatory documents (eCTD format) to regulatory authorities as per client requirement
- Addressing regulatory queries by Regulatory Authorities
- Compliance to National regulatory requirements
- Interaction with the Office of The Drug Controller General of India and office of the State Drug Controller
Expertise
- Extensive experience and knowledge in submitting DMF's, INDs and IMPD.
- Filed API DMF’s to US FDA for supporting ANDA’s on behalf of a US based client.
Facilities