Quality & Approvals — Stancor Pharma
Stancor Pharma works to documented quality systems, with every order released against approved specifications and supporting documentation.
Approvals and certifications
WHO-GMP
Good Manufacturing Practice
Certificate of GMP compliance issued by the state licensing authority under the WHO scheme, covering the sterile and non-sterile blocks and renewed on the statutory cycle.
CDSCO Licensed
Central Drugs Standard Control Organisation
Manufacturing licences held under the Drugs and Cosmetics Act for the dosage forms described on this site, with product endorsements added per approved formulation.
Schedule M
Revised Schedule M Compliance
Premises, utilities, documentation and quality systems built to revised Schedule M — including pharmaceutical quality system, qualification and validation, and computerised system controls.
EU-GMP
European GMP Compliance
EU-GMP compliance for the applicable block, with Annex 1 contamination control strategy, qualified person release arrangements and periodic requalification.
USFDA — Pending
Inspection Pending
Site preparation for USFDA inspection is complete and the inspection is pending. We state this as pending rather than held, and will not represent US approval until the EIR is issued.
ISO 9001:2015
Quality Management System
Certified quality management system covering order handling, change control, supplier qualification, complaint handling and management review.
ISO 14001:2015
Environmental Management
Certified environmental management covering effluent treatment, cytotoxic waste routing through licensed contractors, solvent recovery and emission monitoring.
ISO 22716
Cosmetic GMP
Cosmetic manufacturing under ISO 22716 good manufacturing practice with CDSCO cosmetic licensing, product information files and preservative efficacy testing to ISO 11930.
ICH Q1A(R2)
Stability Programme
Stability studies run to ICH Q1A(R2) with Zone IVb long-term conditions, photostability per Q1B, mapped chambers, calibrated monitoring and out-of-trend investigation.
EU-GMP Annex 1
Sterile Products
Contamination control strategy, Grade A/B environmental monitoring, media fills at defined frequency, and container closure integrity by validated physical method.
Testing and inspection scope
- Sterility testing (membrane filtration, USP/Ph.Eur.)
- Bacterial endotoxin testing (kinetic chromogenic LAL)
- Assay and related substances by HPLC/UPLC
- Osmolality, pH and viscosity for parenteral solutions
- Sub-visible particulate matter (light obscuration)
- 100% automated visual inspection of filled units
- Container closure integrity by validated physical method
- Water content by Karl Fischer (lyophilised products)
- Dissolution profiling across multiple media
- Microbial limits, bioburden and preservative efficacy (ISO 11930)
- Environmental monitoring — viable, non-viable and personnel
- Media fill qualification at defined frequency
Documentation with every order
A full release data pack per batch accompany every despatch. Contact Stancor Pharma for the full documentation list.