Glossary Term
Manufacturing Validation
Definition
Manufacturing validation is a systematic process used to ensure that manufacturing systems, equipment, and processes consistently produce products that meet predefined quality standards and regulatory requirements. In the MedTech industry, validation is critical for compliance with standards like FDA 21 CFR Part 820 and ISO 13485. It includes activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Relevance to the MedTech Industry
Manufacturing validation ensures that medical devices are produced reliably, safely, and within regulatory guidelines. It provides confidence that production processes will consistently yield high-quality products, reducing the risk of defects and recalls while ensuring patient safety and compliance.
Additional Information & Related Terms
Key Components of Manufacturing Validation
Installation Qualification (IQ): Confirms that equipment and systems are installed correctly and according to specifications.
Operational Qualification (OQ): Verifies that equipment operates as intended under specified conditions.
Performance Qualification (PQ): Demonstrates that the process consistently produces products meeting quality requirements under normal operating conditions.
Process Validation: Ensures that the overall manufacturing process is capable of consistently delivering products that meet specifications.
Software Validation: Validates software used in manufacturing, such as MES or ERP systems, ensuring accuracy and reliability.
Related Terms
Process Validation: A subset of manufacturing validation focused specifically on the production process.
Installation Qualification (IQ): The initial phase of validation, ensuring proper installation of equipment and systems.
Operational Qualification (OQ): Testing equipment functionality under expected operating conditions.
Performance Qualification (PQ): Testing to confirm consistent output of high-quality products.
Good Manufacturing Practices (GMP): Regulatory requirements ensuring the consistent production of high-quality products.