Quality & compliance
Auronova quality systems — cGMP and pharmacopoeia-aligned
Auronova Limited aims to establish strong quality systems from the initial stages of development, designing the facility for cGMP compliance and international pharmacopoeia standards.
Standards
What Auronova is designing for
Regulatory readiness is treated as a design input — not a late-stage retrofit.
cGMP guidelines
The facility is being designed as per cGMP standards so that manufacturing practices, documentation culture, and quality controls can mature with the plant.
Pharmacopoeia standards
Quality systems are oriented to international pharmacopoeia expectations including IP, BP, USP, and EP — supporting both domestic and export market ambitions.
Analytical readiness
Data integrity and method quality
Analytical development capabilities are planned around reliable data, validated methods, and modern instrument practices.
21 CFR Part 11 mindset
Analytical instruments and data workflows intended to comply with 21 CFR Part 11 guidelines.
Method development
Analytical method development and validation to support consistent product quality.
Sustainable operations
Process choices that favour efficiency and responsible environmental performance as operations scale.