What we do
Under this pillar, BPCI members can engage in discussions centred on related quality, compliance & regulatory issues, and new technology, innovations in areas of quality & regulatory affairs (GMP, GDP etc.) and policy issues affecting the industry. Activities include knowledge sharing, audit findings, benchmarking, peer to peer learning and the facilitation of networking opportunities through industry initiatives, workshops, forums and webinars. There is strong engagement and biannual meetings between the BPCI QA/QC Steering Group and the HPRA.
How to get involved / Our working grops
This committee focuses on areas centred on Good Manufacturing Practices (cGMP) aligned to the quality and regulatory framework in operation in the (Bio)Pharmaceutical manufacturing industry. This working group committee meets four times a year, a mix of online and in-person meetings.
Key areas of interest:
- Regulatory and related standard(s) requirements
- Inspection audits by regulatory bodies
- Change deviations
- Compliance related matters in emerging third country trade market(s).
Members that should get involved:
- Quality Assurance
- Quality Control
- Regulatory Affairs professionals
Lead by BioPharmaChem Ireland Senior Executive, karina.cassidy@ibec.ie
This committee acts a discussion and benchmarking forum for evolving regulatory expectations, best practices for validation/qualification, manufacturing facility business processes/ technologies that enable lean manufacturing.
Key areas of interest:
- Data integrity
- cGMP validation
- Digitalising manufacturing execution
- Process monitoring
- Human error management
- Process validation
- Paperless validation
- Statistical tools
Members that should get involved:
- Validation professionals
- Quality Operations
- Supply Chain
Lead by BioPharmaChem Ireland Senior Executive, karina.cassidy@ibec.ie
This Committee is a forum for sharing best practices relative to external manufacturing along with the management of third-party partners. This working group committee meets quarterly, online.
Key areas of interest:
- Drivers for external v internal sourcing
- Regulatory and quality requirements of external manufacturing
- Key regulatory and quality areas associated with partnering with a third-party manufacturer
- Trends in outsourcing from emerging markets
- Qualified Person (QP) release
- Collaboration with Contract Manufacturing Organisations (CMO).
Members that should get involved:
- QP managers
- Operations
Lead by BioPharmaChem Ireland Senior Executive, karina.cassidy@ibec.ie
This working group committee oversees the operational and strategic issues arising from the increasingly global and complex pharmaceutical supply chain systems. This working group committee meets four times a year, a mix of online and in-person meetings.
Key areas of interest:
- Good Distribution Practice (GDP)
- Supply Chain Security
- Falsified Medicine Directive
- Supply Chain Management Systems
Members that should get involved:
- Quality Assurance
- Logistics
- Supply chain
Lead by BioPharmaChem Ireland Senior Executive, karina.cassidy@ibec.ie
