Gallus works with clients to design and generate a Validation Master Plan (VMP) for their late-phase products. We provide a full array of studies for characterization and/or comparability in order to provide data generated at manufacturing scale. In addition, we will execute process validation studies to demonstrate the process can consistently produce product according to pre-determined specifications. The entire package is available for clients in preparation for the work with various health authorities as their product heads toward commercialization.

Process validation comprises two workflows – process support studies and process qualification.

As a prerequisite to execution of process validation, Gallus collaborates on a risk-based approach to establish a master validation plan and associated activities. In addition, this approach provides a logical documentation library to support submission and lifecycle validation.

The adjacent diagram represents a high level view of the validation documentation flow and hierarchy.


  • Process characterization
    • Risk assessments
    • Statistical analysis
    • Evaluation of specific parameters at manufacturing scale
  • Validation Master Plan (VMP) design
  • Analytical methods validation
  • Process validation
    • Identification of key process parameters and appropriate operating ranges
    • Definition of critical product quality and process attributes
    • Pre-approved process validation protocols and reports that document the product’s performance against pre-determined specifications

Here are some examples of key process validation items a client may request:

  • At-scale runs to establish critical process parameters
  • Intermediate hold studies – chemical / microbiological (if applicable)
  • Buffer mixing studies
  • Buffer/ media expiration stability work
  • Establishment of key or critical process parameters
  • Container closure studies
  • Creation of a master validation plan and all support protocols and reports
  • Cleaning studies coupon – final verification
  • Bulk stability studies
  • Scale model qualification
  • Shipping container qualification / validation
  • Product contact filter validation
  • Extractable / leachable studies on product contact material
  • Product mixing studies
  • Filter validation and virus removal verification