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USP 382 – Implementation Guide for Parenteral Closure Systems

USP 382 – Implementation Guide for Parenteral Closure Systems

€199,00 EUR
€199,00 EUR
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USP <382> introduces a new approach to the qualification of elastomeric components for parenteral products, focusing on the functional suitability of the packaging and delivery system, rather than solely on material compliance.

This practical implementation guide clearly explains how to interpret and apply USP <382>, integrating it with USP <381> and USP <1382>, and translating regulatory requirements into concrete, audit-ready activities.

Beyond regulatory interpretation, the guide includes structured processes, operational checklists, and real-world case studies, enabling immediate application of the requirements and confident management of audits and inspections.

What you will find inside:

📘 USP <382> requirements explained in an operational way
✅ Step-by-step functional qualification process
🧪 Practical guidance on key tests (integrity, fragmentation, penetration, self-sealing, plungers, and spikes)
📋 Checklists, templates, and scientifically justified acceptance criteria
⚠️ Common pitfalls and how to prevent inspection findings

A hands-on guide designed for QA, QC, Regulatory Affairs, Packaging Development, and Validation professionals involved in injectable products.

Format: Professional PDF
Length: 71 pages
Updated: January 2026
Languages: ITA – ENG

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DECLARED REGULATORY BASIS

Built on the most up-to-date official sources.

Every guide is built from the official sources current at the editorial verification date stated in the document. The editions, revisions and cut-off dates used are declared and checked again for every new release; requirements are kept distinct from GuideGxP operational interpretation.

Main references for this guide USP <382> · USP <381> · EU GMP Annex 1 (2022)
  • Editions and revisions stated in the document
  • Explicit editorial verification date
  • Requirements separated from practical recommendations

GuideGxP is an independent publisher and is not affiliated with, approved by or sponsored by the authorities and organisations cited.

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