Revalidation & Change Control

Role of Validation in Change Control Boards

Role of Validation in Change Control Boards Role of Validation in Change Control Boards Validation plays a critical role in change control processes within the pharmaceutical and biotech industries. It is a key component in ensuring compliance with regulatory standards…

How to Perform Technical Impact Assessment for Changes

How to Perform Technical Impact Assessment for Changes How to Perform Technical Impact Assessment for Changes In the pharmaceutical industry, the regulatory landscape is continuously evolving, necessitating rigorous processes for validation, verification, and compliance. This article provides a structured, step-by-step…

Tools to Automate Change Control Documentation and Tracking

Tools to Automate Change Control Documentation and Tracking Tools to Automate Change Control Documentation and Tracking In the pharmaceutical industry, effective cleaning validation processes are paramount for ensuring product safety and compliance with regulatory standards. This article offers a step-by-step…

How Change Control Affects Process Validation Lifecycle

How Change Control Affects Process Validation Lifecycle How Change Control Affects Process Validation Lifecycle In the pharmaceutical and biologics sectors, ensuring product quality through rigorous validation processes is paramount. One critical component of maintaining this quality is understanding how change…

FDA 483s and Warning Letters Related to Poor Change Control

FDA 483s and Warning Letters Related to Poor Change Control FDA 483s and Warning Letters Related to Poor Change Control Implementing effective change control procedures and conducting robust validation practices are critical components in maintaining compliance and ensuring product quality…

Integrating Change Control with Document Management Systems

Integrating Change Control with Document Management Systems Integrating Change Control with Document Management Systems The pharmaceutical industry is continuously evolving, and managing changes effectively is crucial for maintaining regulatory compliance and ensuring product quality. This article provides a detailed step-by-step…

Multi-Site Change Control Harmonization Best Practices

Multi-Site Change Control Harmonization Best Practices Multi-Site Change Control Harmonization Best Practices Cleaning validation in the pharma industry is pivotal for ensuring product quality and regulatory compliance. In this comprehensive guide, we will discuss a step-by-step approach to harmonizing change…

QA Responsibilities in Revalidation and Change Approval

QA Responsibilities in Revalidation and Change Approval QA Responsibilities in Revalidation and Change Approval In the pharmaceutical and biologics industries, revalidation and change approval are critical components of ensuring product quality and compliance. These activities require a systematic approach that…

How to Write a Revalidation Protocol After Change Control

How to Write a Revalidation Protocol After Change Control How to Write a Revalidation Protocol After Change Control In the pharmaceutical and biotechnology industries, validation is a critical process for ensuring product quality, safety, and compliance with regulatory standards. After…

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…