Quality You Can Audit — WHO-GMP, ISO, FSSAI, HACCP, AYUSH
Every batch traceable from incoming raw material to final dispatch. Every product backed by Certificate of Analysis. Every plant audit-ready.
Full Multi-Division Compliance
WHO-GMP
World Health Organization Good Manufacturing Practices for pharmaceutical manufacturing across critical care injectables and general formulations.
ISO 9001:2015
Quality Management System certification covering all operations from raw material procurement to finished goods dispatch.
FSSAI License
Central FSSAI License (No. 13026999000031) for nutraceutical and health supplement production.
HACCP
Hazard Analysis Critical Control Points certification — food safety compliance for nutraceutical and herbal divisions.
AYUSH License
Ministry of AYUSH license for ayurvedic and herbal medicine manufacturing under traditional medicine guidelines.
Drug License
Schedule C/C(1) Wholesale License (No. WLF21B2026CH000085) — Chandigarh Drug Control. Valid till March 2031.
In-House QC Capabilities
- HPLC (High-Performance Liquid Chromatography) — assay, impurity testing
- UV-Visible Spectrophotometer — quantitative analysis
- Dissolution Apparatus — USP 1, 2 dissolution testing
- Disintegration Apparatus — tablet/capsule disintegration
- Friability Tester — tablet hardness/friability
- Karl Fischer Titrator — moisture content
- FTIR Spectrophotometer — raw material identification
- Microbiology Lab — laminar flow hoods, incubators, microbial limit testing
- Heavy Metal Testing — AAS / ICP-MS where required
- Stability Chambers — 25/30/40°C tracking 24-month shelf life data per ICH
Quality at Every Stage
- 1. Raw Material Quarantine & Testing — Every incoming batch quarantined under “UNDER TEST” label until QC clears via identity, assay, microbial, and heavy metal tests.
- 2. Dispensing in Cleanroom — Grade D cleanroom with controlled humidity and temperature, double-verification on weighing.
- 3. In-Process Checks Every 30 Min — Weight variation, hardness, friability, disintegration tracked on every production run.
- 4. Final Batch Testing — Full panel — assay, dissolution, microbiology, stability indicators — before QA release.
- 5. COA Issued with Every Batch — Certificate of Analysis ships with every dispatch.
- 6. Stability Program — Every batch sampled into stability chambers, data tracked 0/3/6/9/12/18/24 months.
- 7. Documentation — BMR, BPR, deviation reports, change controls, CAPA — all auditable 5+ years back.
Audit Our Quality System
We welcome plant visits, document audits, and tender verification visits. Schedule a visit with our QA team.
Verifiable Compliance & Regulatory Numbers
How to Verify These Documents
Every license number above is independently verifiable on the issuing authority’s website:
- GST: GST portal — Search Taxpayer (enter GSTIN above)
- FSSAI: FoSCoS portal (enter FSSAI number)
- MSME: Udyam verification portal
- Corporate Identity: MCA portal — Company Master Data
Plant Audit & Inspection Welcomed
We welcome pre-contract plant audits from PCD partners, contract-manufacturing clients, hospital procurement teams, and institutional buyers. Standard plant tours run Monday–Saturday, 10:00–17:00 IST. Audit checklists, regulatory documentation packs, and ISO 9001:2015 compliance records are made available 48 hours before scheduled visits. Schedule a plant visit at Nalagarh, Himachal Pradesh.
Quality Management System (QMS)
BIOFRIL HEALTHCARE operates an ISO 9001:2015 Quality Management System covering: incoming raw material testing (API + excipients), in-process quality checks at every manufacturing stage, finished-product release testing per IP/USP/BP standards, retained reference samples for 2 years post batch-expiry, full batch traceability through ERP system, customer complaint resolution within 5 working days, and quarterly internal audits by an independent QA team. CoA (Certificate of Analysis) is generated batch-wise and dispatched with every shipment.
Stability & Reference Standards
Every product SKU in our catalogue has documented stability data: accelerated stability (40°C / 75% RH for 6 months) + real-time stability (25°C / 60% RH for 24 months). Stability data is available to partners and tender authorities on written request. Reference standards used in QC testing are sourced from USP, EP, BP, or IP — with chain-of-custody documentation.