USP 382 – Implementation Guide for Parenteral Closure Systems
USP 382 – Implementation Guide for Parenteral Closure Systems
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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What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.