The BioPharmaChem Ireland (BPCI) working group (WG) committees reflect the diverse evolving activities that occur in a biopharmaceutical manufacturing site. Their purpose is to bring together members from different biopharmaceutical organisations, who are directly or indirectly involved in the manufacturing and supply chain, to discuss and network with peers and stakeholders on generic themes that directly impacts the sector that operates in global markets.
Each WG committee has its key objectives outlined along with the topics it covers. Periodically, driven by industry needs, a subject focus WG group can be developed to address key areas of concern for the sector. In general, the WG committees meet a few times a year with a member driven agenda. Participation and access to any of the BPCI WG committees is open to all employees from BPCI member companies.
How to get involved / Key Working Group Committees
This committee focuses on current Good Manufacturing Practices (cGMP) aligned to the Quality and Regulatory framework in the Biopharmaceutical manufacturing industry.
Key issues it addresses include: record keeping; personnel qualifications; inspection audits (regulatory bodies); change deviations and compliance in emerging third country trade market(s).
Contact: Karina Cassidy (firstname.surname@ibec.ie)This Committee provides a discussion forum for member companies on issues relating to equipment, process and cleaning validation in the industry. Areas such as data integrity, human error management, process validation, paperless validation and statistical tools employed in the Biopharmaceutical manufacturing industry are discussed.
Contact: Karina Cassidy (firstname.surname@ibec.ie)
This Committee is a forum for sharing best practices relative to external manufacturing along with the management of third-party partners. Key issues addressed within this forum are: key drivers for external sourcing; key regulatory and quality areas associated with partnering with a third party manufacturer; qualified person (QP) product release and collaboration with Contract Manufacturing Organisation (CMO).
Contact: Karina Cassidy (firstname.surname@ibec.ie)
This committee manages the operational and strategic issues relating to complex global supply chain systems. Some key issues addressed include: Good Distribution Practice (GDP); Supply Chain Security; and Supply Chain Management systems.
Contact: Karina Cassidy (firstname.surname@ibec.ie)This committee is concerned with issues relating to the compliance of the laboratory within Biopharmaceutical manufacturing in terms of Good Manufacturing Practice (GMP). Areas discussed within this forum include revised regulation(s) that impact the laboratory department, management of laboratory equipment, vendor certification/reduced testing.
Contact: Karina Cassidy (firstname.surname@ibec.ie)
This committee is a discussion forum for issues related to the Good Manufacturing Practices (GMP) training of employees employed within a Biopharmaceutical manufacturing facility. Key area discussed includes the behavioural based quality related documentation and record management systems. As well as up to date learning management systems employed by the industry.
Contact: Karina Cassidy (firstname.surname@ibec.ie)