Analysis

GMP analysis is critical for pharmaceutical products. Being a GMP laboratory and a pre-approval inspected laboratory (PAI inspected), Vanton’s role is to perform GMP compliant tests.

Vanton is capable of:

  • GMP Methods Development and Validation
  • Performing GMP Analyses according to USP/ICH guideline (controlled paper datasheet system to minimize execution deviations)
  • Conducting GMP Stability Testing program (multiple chambers of various climate configurations)
  • Performing audit trail measurements with cloud-based data backup
  • Designing Non-Conventional Analyses per client’s needs

Vanton develop various methods based on the drug product specifications. Typical methods are:

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

Vanton perform GMP testing based on a witness and datasheet system.

  • Witness system – this system incorporate witnesses for critical steps, to minimize laboratory errors. Typical witness is enforced in weighing, material transfer, dilution, HPLC sample loading and sequencing set up. These are common steps causing deviations
  • GMP compliant Datasheet system – datasheets are printed in controlled paper for recording each sample preparation and measuring step. It serves the purpose of keeping track of who does what, how, and when. This system is crucial for investgating out of specification (OOS) or out of trend (OOT)

Vanton’s analytical program has been PAI (pre-approved inspection) inspected and is licensed to perform GMP testing for commercial products.

  • Vanton has high capacity GMP qualified chambers, able to house commercial stability programs for various climate conditions
  • Vanton also has small GMP qualified chambers for small batch studies
  • There are over 200 instruments/tools/kits regularlly qualified for GMP testing needs. Vanton is a one-stop shop for running stability testing program
  • Vanton is able to conduct USP microbial testing (USP<61> and <62>) and product release testing
  • A Visala chamber data logging system that monitor the chamber conditions 24/7 with a timely reporting and warning system
  • Vanton sets up stability protocols with client’s appporval and reports the stability data to client following each time point

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

  • Dynamic conductivity analysis – critical for stability of complex fluids
  • Surface and interfacial tension analysis – to evaluate emulsification
  • Dielectric relaxation analysis – to evaluate dosage form characteristics using various theoretical models
  • Laser penetration and scattering analysis – for early sign of phase separation study (largely for injectable products or liquids)
  • Syringeability measurement – crucial for viscous liquid injection dosage form
  • Laser assisted phase separation measurement – to evaluate injection site robustness/stability
  • Other custom designed analyses
+ Method Development and Validation

Vanton develop various methods based on the drug product specifications. Typical methods are:

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

Vanton perform GMP testing based on a witness and datasheet system.

  • Witness system – this system incorporate witnesses for critical steps, to minimize laboratory errors. Typical witness is enforced in weighing, material transfer, dilution, HPLC sample loading and sequencing set up. These are common steps causing deviations
  • GMP compliant Datasheet system – datasheets are printed in controlled paper for recording each sample preparation and measuring step. It serves the purpose of keeping track of who does what, how, and when. This system is crucial for investgating out of specification (OOS) or out of trend (OOT)
+ Stability Testing

Vanton’s analytical program has been PAI (pre-approved inspection) inspected and is licensed to perform GMP testing for commercial products.

  • Vanton has high capacity GMP qualified chambers, able to house commercial stability programs for various climate conditions
  • Vanton also has small GMP qualified chambers for small batch studies
  • There are over 200 instruments/tools/kits regularlly qualified for GMP testing needs. Vanton is a one-stop shop for running stability testing program
  • Vanton is able to conduct USP microbial testing (USP<61> and <62>) and product release testing
  • A Visala chamber data logging system that monitor the chamber conditions 24/7 with a timely reporting and warning system
  • Vanton sets up stability protocols with client’s appporval and reports the stability data to client following each time point
+ Nonconventional Analysis

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

  • Dynamic conductivity analysis – critical for stability of complex fluids
  • Surface and interfacial tension analysis – to evaluate emulsification
  • Dielectric relaxation analysis – to evaluate dosage form characteristics using various theoretical models
  • Laser penetration and scattering analysis – for early sign of phase separation study (largely for injectable products or liquids)
  • Syringeability measurement – crucial for viscous liquid injection dosage form
  • Laser assisted phase separation measurement – to evaluate injection site robustness/stability
  • Other custom designed analyses

Vanton Labs can help you move your product development forward.

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