Quality and Compliance

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.

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.

BioPharmaChem Senior Executive, Karina Cassidy (firstname.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. 

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. 

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.  

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.

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.