iso 14644 3 – Pharma Validation

Quality Metrics Derived from CPV for Management Reviews

Quality Metrics Derived from CPV for Management Reviews Quality Metrics Derived from CPV for Management Reviews In the ever-evolving landscape of pharmaceutical manufacturing and quality assurance, Continued Process Verification (CPV) serves a pivotal role in ensuring compliance and operational excellence.…

Validation of Vial, Ampoule, and Pre-Filled Syringe Filling Processes

Validation of Vial, Ampoule, and Pre-Filled Syringe Filling Processes Validation of Vial, Ampoule, and Pre-Filled Syringe Filling Processes Validation of filling processes for vials, ampoules, and pre-filled syringes is a critical component in the pharmaceutical manufacturing industry, particularly for aseptic…

Linking Validation Master Plan (VMP) to Revalidation Planning

Linking Validation Master Plan (VMP) to Revalidation Planning Linking Validation Master Plan (VMP) to Revalidation Planning In the pharmaceutical and biologics industries, a well-structured validation approach is fundamental to ensure compliance with regulatory requirements and to maintain product quality and…

Risk-Based Process Validation: Lifecycle Integration

Risk-Based Process Validation: Lifecycle Integration Risk-Based Process Validation: Lifecycle Integration In the world of pharmaceutical manufacturing and biologics, validation is a critical component that upholds the integrity of processes and ensures compliance with regulatory requirements. This article serves as a…

LOD vs LOQ: Definitions, Differences, and Regulatory Significance

LOD vs LOQ: Definitions, Differences, and Regulatory Significance LOD vs LOQ: Definitions, Differences, and Regulatory Significance In the pharmaceutical and biopharmaceutical industries, understanding the Limit of Detection (LOD) and Limit of Quantification (LOQ) is crucial for analytical method validation. This…

Microbial, Particulate, and Oil Testing in Compressed Air

Microbial, Particulate, and Oil Testing in Compressed Air Microbial, Particulate, and Oil Testing in Compressed Air The validation of compressed air systems in pharmaceutical and biologics manufacturing is crucial for ensuring quality and compliance with regulatory standards such as ISO…

Lifecycle Approach to Maintaining and Reassessing CPPs

Lifecycle Approach to Maintaining and Reassessing CPPs Lifecycle Approach to Maintaining and Reassessing CPPs The lifecycle approach to maintaining and reassessing Critical Process Parameters (CPPs) is not only essential for operational efficiency in pharmaceutical manufacturing processes but is also crucial…