A Strategic Lifecycle Approach to Process Validation
Before commercialization and marketing, regulated companies (i.e. FDA, Health Canada, EMA, MHRA, etc.) have the 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, thereby strengthening and reinforcing confidence that the process is highly efficient, compliant, and productive. The basis for the 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 & statistics. analysis (accuracy, precision, standard deviation, confidence interval, Pareto analyses, T-test, etc.)
- Need and determine the basis for any re-validation activity, if required.
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FAQs on Process Validation
1. What is process validation?
Process validation is the documented evidence that a process consistently produces a product meeting its predetermined specifications and quality attributes.
2. Why is process validation important?
Process validation ensures that manufacturing processes are reliable and reproducible, which is crucial for maintaining product quality and regulatory compliance.
3. What are the stages of process validation?
Process validation typically involves three stages:
- Process Design: Developing and defining the manufacturing process based on knowledge gained through development and scale-up activities.
- Process Qualification: Confirming that the process design can be reliably reproduced at commercial scale.
- Continued Process Verification: Ongoing assurance that the process remains in a state of control during routine production
4. What are the key elements of process validation?
Key elements include:
- Critical Quality Attributes (CQAs): Characteristics that must be measured to ensure product quality.
- Critical Process Parameters (CPPs): Variables that must be controlled to ensure the process produces the desired quality.
- Control Strategy: A planned set of controls to ensure process performance and product quality.
5. How is process validation documented?
Documentation includes protocols, reports, and data that demonstrate the process consistently produces a product meeting its quality criteria. This documentation is essential for regulatory submissions and audits.
6. What are the regulatory requirements for process validation?
Regulatory requirements for process validation are outlined in guidelines such as the FDA’s Process Validation: General Principles and Practices and ICH Q7. These guidelines emphasize a lifecycle approach to validation, integrating it into the overall quality management system.
7. What is continuous process validation (CPV)?
Continuous Process Verification (CPV) is an alternative approach to traditional process validation. It involves real-time monitoring and control of the manufacturing process to ensure consistent product quality.
8. How does process validation impact product lifecycle management?
Process validation is integral to product lifecycle management, ensuring that processes remain in control and product quality is maintained throughout the product’s lifecycle.
