Compliance
Psyllium Husk GMP-Compliant Manufacturer India: Facility and Documentation Standards
Compliance.
What GMP-compliant facility means for psyllium processing, BP grade specifications, and the documentation checklist pharma buyers should request from Indian suppliers.
Pharmaceutical buyers sourcing psyllium husk from India require more than a purity grade — they need confirmation that the processing facility operates under documented quality controls consistent with Good Manufacturing Practice (GMP) standards. For psyllium, GMP-compliant processing means controlled milling environments, documented cleaning procedures, pest management records, batch traceability, and calibrated equipment. This applies whether the husk is intended for a USP, EP, or British Pharmacopoeia (BP) laxative formulation.
RM Psyllium operates from a GMP-compliant facility in Siddhpur, Gujarat — the primary psyllium processing hub in India. Our facility maintains batch manufacturing records, equipment calibration logs, and in-process quality checks for each production run. Buyers can request a facility statement confirming applicable GMP controls alongside the COA.
BP Grade vs USP Grade: Key Parameter Differences
Psyllium husk supplied to the UK and Commonwealth markets typically references the British Pharmacopoeia (BP), which aligns closely with the European Pharmacopoeia (EP). The key differences from USP center on minimum swell index and ash limits. Both grades are available from our Siddhpur facility with COA annotated to the buyer-specified pharmacopoeia.
| Parameter | BP / EP | USP |
|---|---|---|
| Minimum Swell Index / Volume | ≥ 40 mL/g | ≥ 40 mL/g (some editions ≥ 55) |
| Purity (Husk Content) | ≥ 98.0% | ≥ 99.0% |
| Total Ash | ≤ 4.0% | ≤ 3.0% |
| Acid-Insoluble Ash | ≤ 0.6% | ≤ 0.4% |
| Moisture | ≤ 12.0% | ≤ 12.0% |
| Lead | ≤ 2 ppm | ≤ 2 ppm |
Pharma Buyer Documentation Checklist
For a pharma import, the standard documentation package from RM Psyllium includes: (1) COA from NABL-accredited laboratory annotated to USP, EP, BP, or IP as specified; (2) Certificate of Origin issued by the Gujarat Chamber of Commerce; (3) Phytosanitary Certificate from the Plant Quarantine Authority; (4) Facility GMP compliance statement on company letterhead; (5) Packing list and commercial invoice. Additional documents — pesticide residue report, heavy metals panel, microbiology extension — available on request.