ICH Q / S / E mapping

Where the guidelines meet the bench.

ICH's Quality, Safety and Efficacy guidelines describe what a regulator needs to see. This is where each one turns into a specific test — Clinic Safe Solutions advises on the required tests and presents you with a solution.

Safety (S) guidelines are vital to bringing your product to the bedside, yet the biggest hurdle. Clinic Safe Solutions provides you with options while keeping costs reasonable.

Regulatory framework ICH Guidelines
Q

Quality

Chemistry, manufacturing & controls

Q1 · Stability
Stability programme & shelf-life data
Q2(R2) · Analytical validation
Method validation & qualification
Q3 · Impurities
Impurity profiling & control strategy
Q5A–E · Biotech quality
Cell banking, viral clearance, comparability
Q6B · Specifications
Release specifications & CoA
Q7 · GMP
GMP batch production & batch records
Q8–Q10 · Development & QMS
QbD, risk assessment, quality management system
S

Safety

Biological & nonclinical safety

S6(R1) · Biotech safety
Biosafety assessment & biodistribution
Adventitious agents
Mycoplasma testing
Adventitious agents
Sterility testing
Bacterial endotoxin
Endotoxin (LAL) testing
Viral safety
Viral clearance & adventitious virus testing
E

Efficacy

Clinical development

E6(R2) · GCP
GCP-aligned clinical batch manufacturing
E8(R1) · General considerations
Clinical trial material planning
Comparability
Bridging studies across process changes
CTD / CMC
CMC documentation for IND / CTA filings
Why this matters

The guideline number isn't the deliverable. The data is.

A guideline reference in a regulatory filing only holds up if the underlying test was actually run, by the right provider that can produce the record behind it.

Not sure where to start?

Drop us an inquiry and we'll tell you which of these actually apply, how your current data matches the requirements, and where the gaps are.

Ask us directly