Dissolution Testing and Compendial Methods in GMP Pharmacopeias – Audit-Ready Operational Guide (USP, Ph. Eur.)

Dissolution testing is one of the most exposed topics during GMP audits.
It is technically complex, highly variable, and often poorly understood—even in experienced laboratories.
Following USP or Ph. Eur. “by the book” is not enough: inspectors expect control, conscious choices, and defensible decisions.

This guide is designed for QC, QA, and QPs working under audit pressure who must take fast, well-reasoned decisions—without getting lost in pharmacopeial chapters, ambiguous interpretations, or repeatedly reworked documents.

It does not explain what the regulation says.
It tells you what to do, how to do it, and how to defend it during an inspection.

The Real Problem

In daily practice, this is what happens:

• USP and Ph. Eur. say similar things… but not identical
• Methods are “compendial”, yet no one clearly defines how far they can be adapted
• S1–S2–S3 criteria are known, but poorly managed under stress
• A dissolution OOS immediately becomes a regulatory time bomb
• Each laboratory applies the method “as it has always been done”
• In an audit, however, every choice must be explained and documented

The result?
Slow decisions, uncertainty in front of the inspector, weak investigations, and days of unnecessary rework.

The Concrete Benefit You Get

With this guide you will:

• Drastically reduce audit preparation time
• Know when a failure is truly an OOS (and when it is not)
• Avoid errors that lead to avoidable deviations
• Manage USP and Ph. Eur. without confusion
• Defend your decisions using inspection logic, not theory
• Face audits with confidence, not in defensive mode

Each chapter is designed to accelerate decisions, not to study regulations.

What the Guide Contains

Immediately usable, not descriptive content:

• Practical interpretation of compendial methods
• Operational comparison of USP vs. Ph. Eur.
• Clear explanation of S1, S2, S3 criteria (with real examples)
• Audit-ready management of:
  • Apparatus
  • Medium
  • Degassing
  • Filters
  • Sampling
• OOS and deviation management for dissolution testing
• Risk-based approach for multi-pharmacopeia decisions
• Operational “Audit-Ready” checklist
• Typical inspection findings (and how to avoid them)

No theory. Operational decisions already made for you.

Why Buy This Guide?

• Regulations are already interpreted
• Critical decisions are guided
• You don’t need to rebuild the reasoning every time
• You avoid unnecessary investigations and avoidable findings
• It costs less than a single day of rework

A guide that pays for itself at the first audit.

Who This Guide Is Really For (and Who It’s Not)

Ideal for:

• QC Analysts & QC Managers
• QA Specialists & QA Managers
• Qualified Persons (QP)
• Regulatory Affairs involved in analytical methods
• Laboratories operating in multi-market environments

Not for:

• Those looking for an academic explanation of pharmacopeias
• Roles without decision-making responsibility
• Professionals not working under audit pressure

This guide is built on real audit experience, not theoretical interpretation.
It is aligned with EMA, FDA, and PIC/S expectations and designed to make dissolution testing defensible, consistent, and audit-ready.

Product Details

• Format: Professional PDF
• Length: 51 pages
• Updated: February 2026
• Languages: ITA – ENG

DOWNLOAD A PREVIEW OF THE GUIDE