Spring Intro 2023

03/03/2023

Process Analytical Technology (PAT) • A system for designing, analysing and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality

• PAT is a useful tool to achieve the desired state

• PAT tools • Multivariate tools for design, data acquisition and analysis • Process analyzers • Process control tools • Continuous improvement and knowledge management tools

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EMA PAT Team

• Created November 2003 to review implications and ensure that European regulatory framework and authorities are adequately prepared to conduct thorough and effective evaluations of PAT-based submissions • 9 + 1 (Chair) Assessors & Inspectors (QWP, BWP, IWG/EDQM observer) • Forum for dialogue and understanding between Quality Working Party and ad Hoc Group of GMP Inspection Services to prepare a harmonised approach in Europe on assessment of applications and inspections of systems/ facilities including new approaches to manufacturing and control of actives substance, medicinal product, packaging etc. (PAT) • SPECIFIC OBJECTIVES: • To define and agree a work plan on an annual basis • Review legal and procedural implications on EU regulatory system including: (Need for revision of existing guidelines and for new guidelines; Batch release; Sampling and testing arrangements by OMCLs; Need for revision of assessment/inspection practices and quality system approaches; Impact on Ph. Eur. activities • Review and comment on relevant documents produced by other organisations (EDQM, FDA etc). • Review of related international procedures and approaches. • Perform review and assessment of “mock” submissions of application using PAT and quality by design principles and prepare a list of key issues with proposals on how to address them • When requested, to provide specialist input into dossier assessment and scientific advice • Develop a procedure for assessment of PAT related applications involving a co-ordinated approach by assessors and inspectors. • Communicate the outcomes to QWP, BWP, IWP and Ad Hoc GMP inspection Services Group for adoption and for wider communication. • Avoidance of disharmony with other regional approaches • Identify training needs of assessors and inspectors (QWP, BWP, IWG/EDQM observer) EMA questions and answers

https://www.ema.europa.eu/en/human regulatory/research-development/quality design#pat-team-mandate-section

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