Leadgene employs a quality management system that upholds both ISO 13485 and GMP/QMS certifications.
An integral component of Good Manufacturing Practice is Quality Control, which focuses on sampling, specifications, testing, organizational measures, documentation, and release procedures. These essential procedures ensure comprehensive tests are conducted and materials or products are not released for use or sale until their quality meets the set standards. The fundamental tenets of Leadgene's Quality Control state that:
Adequate facilities, trained personnel and approved procedures are available for sampling and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP/QMS purposes.
Samples of starting materials, packaging materials, intermediate products, bulk products, and finished products are taken by approved personnel and methods.
Records are made, manually and/or by recording instruments, which demonstrate that all the required sampling, inspecting, and testing procedures were actually carried out. Any deviations are fully recorded and investigated.
The finished products contain active ingredients complying with the qualitative and quantitative composition of the product specification, are of the purity required, and are enclosed within their proper containers and correctly labeled.
Records are made of the results of the inspection and the testing of materials, intermediate, bulk, and finished products is formally assessed against the specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures.
No batch of product is released for sale or supply before certification by an Authorized Person that it is following the requirements of the relevant authorizations.
Sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the sample is retained in the final pack.
The testing items for Leadgene’s GMP-grade products include, but are not limited to:
- Identification: SDS-PAGE with Western blotting
- Concentration: UV spectroscopy
- Purity: SDS-PAGE with Western blotting
- Biological activity: Specific activity determined by product-specific in vitro bioassay, against reference standard and (when applicable) against WHO standards
- Endotoxin test: Kinetic chromogenic LAL assay
- Sterility test: Direct inoculation method
- Mycoplasma test: NAT-based method (PCR)