Tag: Revalidation & Change Control

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…

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…

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…

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 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…

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…

Linking Change Control to Deviation and CAPA Systems

Linking Change Control to Deviation and CAPA Systems Linking Change Control to Deviation and CAPA Systems Cleaning validation is an essential aspect of the pharmaceutical industry, ensuring that residues from previous processes do not compromise the quality of subsequent batches.…

Managing Temporary Changes and Associated Revalidation

Managing Temporary Changes and Associated Revalidation Managing Temporary Changes and Associated Revalidation In the pharmaceutical industry, the validation lifecycle is a critical component of ensuring product quality and compliance with regulatory standards. The relationship between cleaning validation and temporary changes…

Change Control SOP: Elements, Flowcharts, and Templates

Change Control SOP: Elements, Flowcharts, and Templates Change Control SOP: Elements, Flowcharts, and Templates Step 1: Understanding the Importance of Change Control in Pharmaceutical Cleaning Validation In the pharmaceutical industry, cleaning validation is a critical component that ensures the safety…

Risk-Based Approach to Change Control Approval

Risk-Based Approach to Change Control Approval Risk-Based Approach to Change Control Approval Effective change control processes play a critical role in ensuring the integrity of pharmaceutical products, particularly in the realm of cleaning validation in pharma. This step-by-step tutorial provides…