Spring Intro 2023

03/03/2023

Ph. Eur. PAT WP

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Created November 2008 •

Licensing authorities and inspectorates

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Industry Academia

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Terms of reference • Review of existing general monographs and chapters to identify potential revision needs in the field of Process Analytical Technology (PAT) considering the proposals made by the EMEA PAT team. Where appropriate drafting of revised texts. • Identify and where appropriate drafting of new general monographs or chapters in the field of PAT considering the proposals made by the EMEA PAT team (see below). • Updates (as suggested The EMEA PAT team): • 2.9.47 Demonstration of uniformity of dosage units using large sample sizes (adopted) • New general chapters on analytical techniques which may be referred to in PAT-based applications such as acoustics, effusivity or imaging techniques • 5.25 chapter on PAT - Process analytical technology (adopted in November 2018)

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• Summary of Product Characteristics – Not in Compliance with EC Guideline on Summary of Product Characteristics/QRD Template • Labels and leaflets – Not updated in line with Directive 2001/83/EC as amended and relevant guidelines/QRD Template • Invented names – Proposed names too similar to existing names and/or containing INN stem • Refer to relevant Guidelines (HPRA Guideline etc.) Common Deficiencies – Module 1

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