PPQ & Validation Solutions

Process Validation Master Plan (PVMP)

We author and align PVMPs with your overall CMC and regulatory strategy. Our master plans map the full validation lifecycle, ensuring traceability from process characterization to commercial production.

PPQ Risk Assessments, Protocols & Reports

We conduct risk-based assessments and author protocol packages for upstream, downstream, and ancillary systems to support a robust PPQ strategy.

• Identification of critical process parameters (CPPs)

• Sampling plans and acceptance criteria

• End-to-end protocol execution and reporting

Upstream & Downstream Validation Support

We provide full-scope validation across DS/DP unit operations and associated peripherals to enable commercial readiness. Includes:

• Fermentation & cell culture validation

• Purification (Chromatography, UF/DF, filtration unit operations)

• Fill/finish and drug product (DP) integration

Specialized Validation Studies

• LIVCA Studies: Lifecycle Validation of Critical Assets (LIVCA) for chromatography columns, filters, and critical systems.

  • Column resin lifetime & regeneration tracking

  • Post-commercial monitoring plans

  • Equipment-specific risk mitigation strategies

• Mixing Studies: Validation of blend uniformity and dissolution time for buffers, media, and complex formulations.

  • Homogeneity assessments

  • Difficult-to-dissolve compound risk mapping

• Microbial Hold Time Studies: Time-based microbial risk assessments to support hold periods for in-process materials.

  • Grouping approaches for buffers/media

  • Bioburden and endotoxin limit justification

• Stability Studies (DS/DP): Execution and trending of real-time and accelerated stability to support shelf life and retest intervals.

  • Protocol development & pull schedule

  • Trending and data summary for submission

• Membrane and Resin Reuse Studies: Validation of UF/DF membrane and chromatography resin re-use across lifecycle.

  • Cleaning validation and leachables assessment

  • Ongoing lifecycle support post-launch