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