Quality & GMP
Manufactured under good manufacturing practice
Quality is built into every batch — from incoming raw material through to the sealed, serialised carton. Our pharmaceutical quality system follows the ICH Q8–Q10 framework and good manufacturing practice, with defined specifications, validated methods and release testing before any pack leaves the facility.
Batch releaseIn spec
USL
LSL
n = 11all within specification
A single pharmaceutical quality system governs development, manufacturing, testing and release. Nothing ships without a passing batch record reviewed against its specification.
GMP
Manufacturing standard
ICH
Q8–Q10 quality system
100%
Batches release-tested
Rx
Prescription only
Pharmaceutical quality system (ICH Q10)
- Monitoring
- Process performance & product quality
- CAPA
- Corrective & preventive action
- Change management
- Controlled, assessed change
- Management review
- Governance & oversight
Principles
- Defined specifications for every raw material, intermediate and finished product.
- Quality risk management applied throughout (ICH Q9).
- Batch records reviewed and approved before release.
- Retained samples and stability monitoring for each batch.
- Every carton serialised and independently verifiable.
The quality system is built on the ICH Q8(R2) / Q9 / Q10 framework and applicable GMP.