Implementation of Continued Process Verification Program for Post-Market Compliance and Product Success: Poster Presented at PDA Week 2025
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View abstract on PubMed
Summary
This summary is machine-generated.Continued Process Verification (CPV) is crucial for pharmaceutical manufacturing, yet often overlooked. This case study details implementing a CPV program for existing and new products to ensure ongoing process control and regulatory compliance.
Area Of Science
- Pharmaceutical Manufacturing
- Regulatory Compliance
- Quality Assurance
Background
- Continued Process Verification (CPV) is the third stage of FDA Process Validation guidelines.
- CPV is essential for maintaining control throughout a product's lifecycle.
- Many companies neglect CPV, unaware of its regulatory necessity.
Purpose Of The Study
- To highlight the importance of CPV in pharmaceutical manufacturing.
- To describe key steps for successful CPV program implementation.
- To provide a phased approach for both legacy and new products.
Main Methods
- Utilized a case study approach.
- Described key steps for CPV program implementation.
- Employed a phased-approach for diverse product types.
Main Results
- Demonstrated a practical framework for CPV implementation.
- Addressed CPV for both legacy and newly validated products.
- Highlighted the critical nature of CPV for regulatory adherence.
Conclusions
- Successful CPV program implementation is achievable with a structured approach.
- CPV is a vital regulatory requirement for sustained pharmaceutical process control.
- Proactive CPV implementation ensures product quality and manufacturing integrity.
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