Tag: product and process validation

Use of Gantt Charts for Tracking Validation Timelines

Use of Gantt Charts for Tracking Validation Timelines Using Gantt Charts for Effective Management of Validation Timelines The pharmaceutical industry is subject to stringent regulations that require rigorous documentation and adherence to established protocols during product and process validation. A…

Incorporating Feedback Loops from CPV to Process Design

Incorporating Feedback Loops from CPV to Process Design Incorporating Feedback Loops from CPV to Process Design In the pharmaceutical industry, the integration of Continued Process Verification (CPV) into the product and process validation lifecycle is paramount for ensuring product quality…

Retrospective Media Fill Review in APR/PQR

Retrospective Media Fill Review in APR/PQR Retrospective Media Fill Review in APR/PQR The effectiveness of aseptic processes in pharmaceutical manufacturing is critical in ensuring product safety and efficacy. A significant aspect of this validation process is the media fill test,…

Case Study: Revalidation Due to Raw Material Supplier Change

Case Study: Revalidation Due to Raw Material Supplier Change Case Study: Revalidation Due to Raw Material Supplier Change The pharmaceutical industry is governed by stringent regulations that require the validation of processes and products to ensure safety and efficacy. When…

Risk Tools for Cleaning Validation in Multi-Product Plants

Risk Tools for Cleaning Validation in Multi-Product Plants Risk Tools for Cleaning Validation in Multi-Product Plants The pharmaceutical industry is characterized by stringent regulatory requirements that emphasize the importance of product and process validation. For multi-product plants, the challenge is…

Troubleshooting Linearity Failures in Method Development

Troubleshooting Linearity Failures in Method Development Troubleshooting Linearity Failures in Method Development Step 1: Understanding User Requirements Specification (URS) and Risk Assessment In developing effective validation protocols, the first critical step involves creating a User Requirements Specification (URS). A well-defined…

HVAC Failures in FDA Inspections: Lessons Learned

HVAC Failures in FDA Inspections: Lessons Learned HVAC Failures in FDA Inspections: Lessons Learned The pharmaceutical industry faces strict regulatory standards to ensure product quality and patient safety. Among the critical systems that support manufacturing processes, Heating, Ventilation, and Air…

Hold Time Validation for Bulk and Intermediate Products

Hold Time Validation for Bulk and Intermediate Products Hold Time Validation for Bulk and Intermediate Products: A Step-by-Step Guide Hold time validation is a crucial aspect of product and process validation in the pharmaceutical industry. It provides assurance that products…