Vanton is experienced in:

• cGMP Methods Development and Validation
• Performing analyses according to USP/ICH guidelines
• Conducting a cGMP Stability Testing program (Vanton operates chambers of various climate configurations)
• Performing audit trail measurements with cloud-based data backup
• Designing non-conventional analyses per client’s needs

Vanton is experienced in the development of analytical methods, including:

• HPLC assay, dissolution, purity, and content uniformity methods
• Microbial methods (USP<61> and USP<62>)
• Water content
• Non-conventional SR dosage form dissolution methods
• Physical methods (e.g., tackiness for patch, adhesion tests, visual description)
• Conductivity, viscosity, and syringe-ability for injectable products
• Specific methods for specific products (e.g., density and dynamic viscosity specification establishment)

Vanton performs fully cGMP – compliant testing

• Complete Quality System oversight of the entire process
• Witness system – this system incorporates witnesses for critical steps to minimize laboratory errors
• cGMP-compliant Datasheet system – datasheets are printed and controlled for recording sample preparation and measuring steps. This serves the purpose of keeping track of who does what, how, and when and is crucial for investigating out of specification (OOS) or out of trend (OOT) results

Vanton designs special analysis methods to assist in formulation development or to evaluate unconventional parameters:

• Laser penetration and scattering analysis – for early signs of phase separation (injectable products or liquids in the R&D phase/feasibility)
• Syringe-ability measurement – crucial for viscous liquid injection dosage forms
• Laser assisted phase separation measurement – to evaluate injection site robustness/stability
• Other custom-designed analyses