Quality and Compliance

The BPCI working groups mirror the diverse activities that are ongoing in a biopharmaceutical manufacturing site. Their purpose is to bring together members from different organisations, who are directly or indirectly involved in manufacturing chain, to discuss non-proprietary information and resolve universal issues. Each group has a charter outlining the broad topics that they cover but smaller sub-groups can be formed to tackle specific tasks or projects in more granular detail. Typically, the groups aim to meet once a quarter with the agendas developed from member feedback, although this may vary as needs be. Access and participation in the groups is open to all employees of BPCI member companies. 

 

How to get involved / Working groups

The GMP Laboratory group covers lab equipment management/maintenance - particularly obsolescence and validation, Computer System Validation (Data Integrity), Process Analytical Technology (PAT), Training/qualification for analysts/chemists, Vendor certification/reduced testing. Changes in regulations that impact the GMP Lab are also covered e.g. ICH Q3D on Elemental Impurities, FDA Assay Development and Validation, Water for Injection - Reverse Osmosis.

Lead by BioPharmaChem Executive, Enda Dempsey, (firstnane.surname@ibec.ie)

 

 

The GMP Quality and Regulatory Affairs is a broad group which discusses the latest changes in Quality and Regulatory Affairs. Recent audits/regulator trends and FDA Quality Metrics are a standing item. Key issues include Data Integrity, Annex 16 – Change deviations and compliance in emerging markets – China, India, Brazil.

Lead by BioPharmaChem Executive, Enda Dempsey, (firstnane.surname@ibec.ie)

 

The GMP Cleaning Validation is a spin-out group from GMP Validation. The main area of interest equipment cleaning processes and strategies. Currently designing a detailed benchmarking survey across the different industry sectors e.g. API, Drug Product, Fill Finish, Tableting etc. Also cover individual technical issues. 

Lead by BioPharmaChem Executive, Enda Dempsey, (firstnane.surname@ibec.ie)

 

GMP Training working group manages all aspects of employee GMP training, engagement and Behavioural Based Quality and documentation/record management. Some recent topics are Data Integrity, Learning Management systems, On-the-Job Training, Vendor Training. 

Lead by BioPharmaChem Executive, Enda Dempsey, (firstnane.surname@ibec.ie)

 

The External Manufacturing working group is responsible for sharing share best practice in External Manufacturing and the management of third-party partners. An overview of some the issue covered are; Drivers for External v Internal Sourcing, regulatory and quality imperatives of External Manufacturing, trends in outsourcing from Emerging Markets, tolling, QP release and collaborating with CMOs. The External Supply QA Strategy is a subgroup for External Manufacturing, but it will specifically look at the challenges for Quality oversight of product manufactured by external partners. Topics include QA Oversight of CMOs / Suppliers; Risk Management; Regulatory compliance; Mutual Recognition Agreement; Industry Hot topics e.g. serialization; Human Error Management; Data Integrity.  

Lead by BioPharmaChem Executive, Enda Dempsey, (firstnane.surname@ibec.ie)

 

Supply Chain working group manages operational and strategic issues that arise from the increasingly global and complex supply chain systems. Some of the key topics include; Good Distribution Practice, Supply Chain Security, Falsified Medicine Directive and Supply Chain Management systems.

Lead by BioPharmaChem Executive, Enda Dempsey, (firstnane.surname@ibec.ie)

 

The Serialisation group is has one interest, the impact of the Falsified Medicines Directive (FMD), in particular, the need to serialise prescription medication and some over-the-counter products. Two main strands are the EMVO/IMVO and installation/refitting of production lines to meet the new standards.

Lead by BioPharmaChem Executive, Enda Dempsey, (firstnane.surname@ibec.ie)