↔ Product Design
Formulation draws on the substance master
A formulation references the substances it is built from rather than restating their identity and grade, so a change to a material reaches the formulation that uses it.
The substance is the source of record
An API, an excipient, a raw material: each carries an identity, a grade, an impurity profile, and a supplier behind it. Most operations retype that information into every dossier, every specification, every batch record. Krevyos holds each substance once, as a master the whole operation draws from, so a change to a source or a limit reaches every place it is used.
- Domain owner
- Head of CMC · Analytical Lead · Regulatory CMC
- Substance types
- Active ingredients · Excipients · Raw materials · Reagents · Reference standards
- Standards
- USP · Ph. Eur. · JP · ICH Q3A/B/C/D · ICH M7 · FDA IID
Capabilities
Substance masters for API, excipient, and raw material
Each substance held once, with its identity, grade, and specification: the API, every excipient, and every raw material draw from one record rather than a copy pasted into each product.
- API / Excipient / Raw material
- USP / Ph. Eur. / JP grades
Impurity and degradation profiles per ICH Q3A/Q3B
Related substances, degradation products, and nitrosamine risk assessments held against the substance they belong to, so a new impurity finding surfaces everywhere that substance is filed.
- ICH Q3A / Q3B
- Nitrosamine risk
- Genotoxic (M7)
DMF and CEP linkage to the supplying source
The supplier's Drug Master File or Certificate of Suitability is linked to the substance it supports, so a DMF update or a CEP revision is visible to every dossier that relies on it.
- US DMF Type II
- EDQM CEP
- ASMF
Excipient precedents against the FDA IID
Excipient levels checked against Inactive Ingredient Database precedents as they are set, so a level that exceeds precedent is caught in development rather than in a deficiency letter.
- FDA IID limits
- Ph. Eur. functionality
Elemental impurities and residual solvents per ICH Q3D/Q3C
Elemental impurity and residual solvent assessments held as part of the substance record, so risk is evaluated once and reused across every product that uses the material.
- ICH Q3D
- ICH Q3C
- Class limits
Touchpoints
↔ Analytical Development
Methods test against the substance specification
Analytical methods and their acceptance criteria are anchored to the substance specification, so a spec change and the method that verifies it never drift apart.
← Organizations & Resources
Suppliers and their master files
Each substance carries the supplier and the DMF or CEP behind it, so a supplier change and its qualification status are part of the substance record, not a separate spreadsheet.
→ Regulatory Affairs
Module 3 substance sections
Drug substance and drug product quality sections are generated from the substance masters, so Module 3 reflects the current identity, limits, and impurity profile without re-entry.
↔ Quality Management
Specifications and out-of-specification limits
Release and stability specifications share the substance record with the quality operation, so a limit change and the results tested against it stay consistent.
Outcomes
- −70%(indicative)
Time to assemble Module 3 substance sections
Quality sections are drawn from the substance masters instead of retyped, so assembling a dossier's substance content is a fraction of the manual effort.
Duplicate substance records across products
One master per substance means a material used in ten products is defined once, not maintained in ten diverging copies.
- 100%(indicative)
Impurity limits traced to a source
Every impurity and residual-solvent limit points back to the standard and assessment behind it, so a limit is never an orphaned number.
- +2×(indicative)
Reuse of a qualified substance across products
A substance already qualified for one product carries its full profile into the next, so onboarding a new product to a known material starts from what is already established.
Figures marked indicative are directional benchmarks against comparable generics operations; per-customer numbers replace them in working sessions.
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