• 09 APR 13
    Method Development and Validation

    Method Development and Validation

    Method Development
    We have considerable experience in developing analytical methods for the complete range of our analytical portfolio, and for the entire life cycle of a drug. Typical applications are,

    • Quality Control of APIs, starting material, intermediates and finished products
    • Stability testing
    • Characterization of substances
    • Formulation development
    • Cleaning validations
    • Packaging material testing, leachables and extractables
    • Health, Safety and Environment
    • Specialized applications, troubleshooting

    Validation
    At the method development stage, initial validation tests are performed to ensure that the method is scientifically sound and delivers the required results. When used in a GMP environment, methods are formally validated following the ICH guidelines, including preparation of validation protocols and reports. To provide cost-effective solutions, FCAD offers validation programs adapted to the development stage of the drug, and in line with the customer’s quality requirements.

    Complete Analytical Development Programs
    Because we have the expertise and capacity to perform comprehensive analytical development programs for a given drug substance, we are able to serve our clients with know-how and access to a broad lab infrastructure similar to a big-pharma environment.

    Method Transfer
    Methods developed at FCAD can be readily applied to perform routine analyses within our company. Alternatively, FCAD can transfer methods to the customer following ICH guidelines and according to GMP quality standards. Additional training of personnel at the customer site is also possible.

    Typical Methods Developed for Quality Control Purposes

    Assay HPLC, titration
    Purity, Impurities HPLC, CE, GC, TLC, IC, polarography
    Water content Karl-Fischer, loss on drying
    Heavy metals ICP-OES, ICP-MS, AAS
    Residual solvents Headspace GC
    Microbial purity Ph. Eur, USP, harmonized methods
    Particle size Laser diffraction, sieving, microscopy
    Identity IR, NMR, MS, HPLC
    Dissolution Ph. Eur. 2.9.3, USP<711>
    Physical chemistry pH, viscosity, osmolality

    Technological Capabilities

    • Chemical Research

      Chemical Research to remain competitive and meet the demand for more complex structures.

    • Manufacturing Support

      Manufacturing Support Service for process transfer from the development stage to production.

    • Manufacturing Capabilities

      Manufacturing Capabilities from research level production to full cGMP manufacturing.

    • Application Research

      Application Research with continuous investment to bridge the gap between basic research and application.

Service & Support

  • Manufacturing Support Service for process transfer from the development stage to production.

  • Method Development & Validation Service for the analytical portfolio and the entire life cycle of a drug.

  • Process Optimization Service to developing a new process or improve existing synthetic route.

  • Formulation Development Service for surfactants, preservatives, fragrances, resins, pigments…

  • Custom Synthesis Service provided by our professional teams focusing on different classes.