Quality, regulatory & compliance
Compliance is designed in, not added on. Our systems, documentation and facility are being built for the world’s most demanding regulators.
Audit-ready by design
Stringent controls at every stage of procurement, manufacturing, testing and distribution, aligned to WHO-GMP, USFDA, EU-GMP, ISO and USP / EP / IP / BP standards.
- Standard Operating Procedures for all manufacturing and quality activities
- Electronic Batch Manufacturing Records (eBMR) with full traceability
- OOS / OOT investigation protocols
- Change control, deviation management and CAPA
- Vendor qualification and raw-material approval programme
- Annual Product Quality Review (APQR)
- Risk-based process, cleaning and analytical-method validation
- Stability programme per ICH Q1A
Our path to global market access
Targets are planned timelines, not certifications currently held.
| Certification / approval | Target | Benefit |
|---|---|---|
| Drug Manufacturing Licence (Haryana) | FY 2027–28 | Legal manufacturing authority in India |
| Schedule M — GMP (India) | FY 2027–28 | Domestic pharma supply compliance |
| ISO 9001:2015 Quality Management | FY 2027–28 | Global quality recognition |
| FSSAI Manufacturing Licence | FY 2027–28 | India nutraceutical market |
| AYUSH Manufacturing Licence | FY 2027–28 | India AYUSH market |
| WHO-GMP Certificate | FY 2028–29 | Export to 140+ regulated markets |
| US Drug Master File (USFDA-DMF) | FY 2028–29 | USA market access |
| CEP (EDQM — European Pharmacopoeia) | FY 2028–29 | European market access |
| ISO 14001 Environmental Management | FY 2028–29 | ESG compliance, EU supply chain |
| MHRA UK Facility Registration | FY 2029–30 | UK market access |
| USFDA Facility Inspection (Phase 1) | FY 2029–30 | USA market-entry validation |
| Phase 2 GMP Certification (Vitamin D3) | FY 2029–30 | Phase 2 export readiness |
Standards we build to
| Regulation / standard | Governing body | Relevance |
|---|---|---|
| Drugs and Cosmetics Act, 1940 | Ministry of Health | Core manufacturing licence framework |
| Schedule M — GMP | CDSCO | Indian GMP standard for API manufacturing |
| WHO TRS 986 | WHO | International GMP standard — export markets |
| ICH Q7 | ICH | Global API GMP standard |
| ICH Q3D — Elemental Impurities | ICH | API purity and impurity standards |
| 21 CFR Part 211 | USFDA | US GMP compliance for DMF filing |
| Directive 2001/83/EC | EMA / EDQM | EU medicinal-products compliance |
| Pharmacopoeial standards | USP / EP / IP / BP | Analytical and quality standards |
| Environment Protection Act, 1986 | CPCB / HSPCB | Effluent treatment, ZLD compliance |
| Factories Act, 1948 | Labour Dept., Haryana | Workplace safety and welfare |
Current registrations & licences
Chemicraft holds its Drug Trade Licences from the Government of Haryana and all key identifiers for domestic and export operations. Supporting documents are available to authorised parties on request.
Frequently asked questions
Which standards does Chemicraft build its quality system to?
The quality system is designed around Schedule M, WHO-GMP, ICH Q7, 21 CFR Part 211 and EU medicinal-product requirements, with USP, EP, IP and BP pharmacopoeial standards.
When will WHO-GMP, USFDA-DMF and CEP be targeted?
WHO-GMP, US Drug Master File and CEP (EDQM) are targeted for FY 2028–29. MHRA UK registration and a USFDA facility inspection are targeted for FY 2029–30. These are planned timelines, not certifications currently held.
How is batch traceability ensured?
Chemicraft plans a fully electronic batch manufacturing record (eBMR) system with end-to-end traceability from raw-material receipt through manufacturing to final product release, supported by change control, deviation management and CAPA.
How can authorities or auditors request documents?
Authorised parties can request supporting documents through the contact form using the "Regulator / auditor" enquiry type, or by writing to business@chemicraftpharma.com.
Questions on compliance or documentation?
Our compliance and regulatory team responds to supplier questionnaires and audit requests.