Tag: Revalidation & Change Control

Change Control Record Retention and Closure Timelines

Change Control Record Retention and Closure Timelines Change Control Record Retention and Closure Timelines Ensuring the integrity of the pharmaceutical manufacturing process is paramount for compliance with Good Manufacturing Practices (GMP) and regulatory expectations. A critical component in maintaining this…

Regulatory Acceptance of Risk-Based Revalidation Decisions

Regulatory Acceptance of Risk-Based Revalidation Decisions Regulatory Acceptance of Risk-Based Revalidation Decisions In the pharmaceutical industry, ensuring the consistent quality of products through rigorous validation processes is a fundamental requirement. As regulatory expectations evolve, so too must the approaches taken…

Incorporating Risk Scoring in VMP for Revalidation Scheduling

Incorporating Risk Scoring in VMP for Revalidation Scheduling Incorporating Risk Scoring in VMP for Revalidation Scheduling The validation lifecycle of pharmaceutical processes is paramount to ensure compliance with regulatory mandates and to guarantee product quality. A critical aspect of this…

Risk-Based Cleaning Revalidation: Sampling Reduction Models

Risk-Based Cleaning Revalidation: Sampling Reduction Models Risk-Based Cleaning Revalidation: Sampling Reduction Models Cleaning validation is a crucial aspect of the pharmaceutical manufacturing process, ensuring that equipment remains safe for use and free from contaminants. In an era where efficiency and…

Integration of FMEA Tools into Revalidation Planning

Integration of FMEA Tools into Revalidation Planning Integration of FMEA Tools into Revalidation Planning The pharmaceutical industry operates under stringent quality regulations and validation requirements to ensure that products are safe, effective, and of high quality. A critical component of…

Risk-Based Revalidation SOP with Case Examples

Risk-Based Revalidation SOP with Case Examples Risk-Based Revalidation SOP with Case Examples In the highly regulated pharmaceutical industry, maintaining compliance while ensuring quality through validation is paramount. This article provides a step-by-step tutorial focusing on Risk-Based Revalidation, particularly applicable in…

How to Use Risk to Justify Delay or Waiver of Revalidation

How to Use Risk to Justify Delay or Waiver of Revalidation How to Use Risk to Justify Delay or Waiver of Revalidation In the pharmaceutical industry, the validation lifecycle plays a critical role in ensuring that processes remain in a…

Case Study: Risk-Based Revalidation Saves Time and Cost

Case Study: Risk-Based Revalidation Saves Time and Cost Case Study: Risk-Based Revalidation Saves Time and Cost Step 1: Understanding Process Design and User Requirements Specification (URS) Process validation is a lifecycle that ensures processes consistently produce products that meet predetermined…

Risk-Based Requalification Plan for Facility Systems

Risk-Based Requalification Plan for Facility Systems Risk-Based Requalification Plan for Facility Systems In the pharmaceutical industry, maintaining compliance with regulatory expectations is paramount. The process of validation encompasses various stages, including Process Design, Qualification, Process Performance Qualification (PPQ), Continued Process…

Using Product Quality Trends to Trigger Revalidation

Using Product Quality Trends to Trigger Revalidation Using Product Quality Trends to Trigger Revalidation In the pharmaceutical industry, maintaining compliance with regulatory standards is paramount for ensuring product quality. The process validation lifecycle comprises several critical steps that can significantly…