How the plant is built, how product is tested, and how to arrange an audit.
Product moves through closed systems from reaction to packing, with no open handling.
Validated processes run in GMP-approved SS316 vessels. All product-contact machinery is pharmaceutical-grade stainless steel, cleaned under validated protocols.
Custom material-handling systems move product between stages with no open handling and no human contact, under filtered air.
Controlled drying to grade-specific moisture targets, monitored against the monograph's loss-on-drying limits.
Particle size and bulk density brought into the grade window — including custom bulk-density specifications developed with customers.
Magnesium carbonate, oxide and hydroxide granules are made by dry roll compaction. Powder is compressed between rolls and sized into granules, with no binder and no additive. Flow and density suit direct compression.
Custom in-line magnetic separators eliminate metallic impurity from every powder and granule stream before packing.
GLP laboratory tests raw materials, intermediates and finished product — elemental impurities (V, Pb, As, Hg, Ni, Co) are tested by ICP-MS at accredited partner laboratories and kept within guideline limits. Release strictly against IP, BP, USP, Ph. Eur. or FCC.
Batch-labelled packing with complete batch records, retained samples, ongoing stability studies and documented recall readiness.
Elemental impurities are quantified by ICP-MS at accredited partner laboratories and reported per ICH Q3D. Reagents are validated with documented usage history. Water quality is monitored to pharmacopoeial standards. Batch samples are retained per requirement, and long-term and short-term stability studies run continuously.
Full batch traceability at all times. Change control tracked in an in-house database. Validation protocols cover processes, equipment, test methods and cleaning. Data-integrity standards and SOP compliance are enforced; recall plans are documented and rehearsed.
Batch data trended; APQR per product.
No shared lines. No cross contamination.
Controlled by magnetic separation, filtered air and line clearance.
Controlled grade-wise; custom windows on request.
Every input tested; qualified vendors only.
Documented QMS workflows; customers notified where agreed.
Retained per batch; stability programs ongoing.
Nitrosamine, melamine, TSE/BSE and GMO statements supplied.
ICP-MS at accredited partner laboratories, per ICH Q3D.
Annual maintenance contracts; preventive schedules.
Customer specifications (IH), COA formats and audit support.
BMR per batch; complete batch history; recall plans documented and rehearsed.
We host customer audits and will walk your team through production, the laboratory and our documentation. Write to info@rhinelabs.in to schedule.
All certificates are supplied with vendor-qualification documentation — together with COAs, TDS, stability data and elemental-impurity data per ICH Q3D.
Send us your vendor questionnaire, request our documentation pack, or book a plant audit.