Before commercialization and marketing, regulated companies (i.e. FDA, Health Canada, EMA, MHRA etc.) have a mandate to provide sufficient evidence that their manufacturing, packaging/labelling, storage and transportation processes will consistently meet predefined quality targets and performance expectations. Only a scientifically rigorous and robust process validation methodology assures continual safety, identity, strength, purity, and quality of therapeutic products.
As demonstrating process compliance with regulatory requirements becomes increasingly complex for the life sciences industry, using an experienced and knowledgeable service partner like AXSource Consulting to guide these efforts will likely pay huge dividends.
AXSource Consulting uses a lifecycle approach to process validation that provides a well-planned, risk-based and cost-effective approach to ensure an effective control strategy for your new or marketed products. Our approach utilizes data sets acquired throughout the process qualification activities to determine when statistically significant variability estimates and evaluation have been achieved and thereby strengthening and reinforcing confidence that the process is highly efficient, compliant, and productive. The basis for development of this methodology goes back to globally harmonized process validation approaches including FDA Process Validation: General Principles and Practices, and it has been updated to include EU Annexure 15, WHO Process Validation Guide, concepts covered in ICH Guidelines from Q8 to Q11 and China’s FDA Validation Guide.
Overall outline of AXSource’s Validation Master Plan (VMP), states how the validation will be conducted, including:
- Purpose & Scope of Validation
- Regulatory and statutory requirements
- Detailed Roles & Responsibilities
- List of key guidance documents from competent Health Authorities (Health Canada, FDA, TGA, Japan, EMA, MHRA)
- List of required protocols, SOPs (Standard Operating Procedures) and their associated quality records (forms, checklists), including:
- FAT (factory acceptance test) protocols vs. SAT (site acceptance test) protocols
- Task and resource management checklists and plan
- Establishing the testing parameters & priorities
- Identification of all input materials, equipment, other internal & external resources
- Detailed sampling plan & sample sizes
- Testing methodology & specifications
- Calibration & maintenance procedures & schedules
- Product characteristics and acceptability criteria
- List of process equipment to be used
- Number of batches to be used
- Definition of acceptance criteria with statistical significance limits
- List of various statistical methods to be employed for validation & statistical analysis (accuracy, precision, standard deviation, confidence interval, Pareto analyses, T-test, etc.)
- Need and determining the basis for any re-validation activity, if required