In technology transfer (TT) within industrial pharmacy, qualification and validation are essential to ensure that transferred processes, equipment, and systems consistently produce high-quality products at the receiving site.
Qualification in Technology Transfer
Qualification verifies that equipment and systems at the receiving site meet the requirements of the transferred process and operate within specified limits.
Design Qualification (DQ): Confirms equipment or system design matches the specified requirements.
Installation Qualification (IQ): Ensures correct installation according to manufacturer and TT specifications.
Operational Qualification (OQ): Verifies that equipment operates as intended within required ranges.
Performance Qualification (PQ): Demonstrates consistent performance under actual production conditions.
Validation in Technology Transfer
Validation shows that processes and systems transferred from the original site can reliably meet quality standards at the receiving site.
Types of Validation:
Process Validation: Confirms the manufacturing process produces quality-compliant products.
Analytical Method Validation: Verifies that transferred testing methods are accurate and reliable.
Cleaning Validation: Ensures equipment can be cleaned to safe standards, preventing contamination.
Computer System Validation: Confirms computer systems meet quality-critical requirements in the new environment.
Importance of Qualification and Validation in Technology Transfer
Regulatory Compliance: Meets FDA, EMA, and other regulatory standards for quality and safety.
Consistency: Ensures product quality is identical across both sites.
Cost-Efficiency: Reduces risks of production errors and costly recalls.
Risk Management: Identifies and mitigates risks to ensure a smooth transfer.
In TT, qualification and validation uphold quality, safety, and regulatory compliance, ensuring successful product transfers across facilities.