Tag: FDA guidelines

What Goes in the Appendix of a Process Validation Report

What Goes in the Appendix of a Process Validation Report What Goes in the Appendix of a Process Validation Report When preparing a Process Validation Report (PVR), a critical component is the appendix, which serves as a repository for auxiliary…

How to Define Acceptance Criteria in Validation Documents

How to Define Acceptance Criteria in Validation Documents How to Define Acceptance Criteria in Validation Documents GxP validation is a critical aspect of pharmaceutical development and manufacturing that ensures quality, safety, and efficacy of products. A key component of this…

Common Mistakes in Writing Validation Protocols

Common Mistakes in Writing Validation Protocols Common Mistakes in Writing Validation Protocols In the pharmaceutical industry, the integrity of systems, processes, and documentation is paramount to ensuring product quality and compliance. This article provides a comprehensive, step-by-step guide geared towards…

Difference Between Protocol and Report in Process Validation

Difference Between Protocol and Report in Process Validation Difference Between Protocol and Report in Process Validation In the world of pharmaceutical manufacturing, ensuring quality and compliance is paramount. One of the critical components of this endeavor is understanding the essential…

Key Elements of a Good Process Validation Report

Key Elements of a Good Process Validation Report Key Elements of a Good Process Validation Report Process validation is an essential part of the pharmaceutical development and manufacturing lifecycle. It not only guarantees product quality but also ensures compliance with…

How to Write a Process Validation Protocol: Step-by-Step

How to Write a Process Validation Protocol: Step-by-Step How to Write a Process Validation Protocol: Step-by-Step In the pharmaceutical industry, the need for compliance with regulatory expectations drives the necessity for robust and comprehensive validation protocols. This article presents a…

Using CPV Outcomes to Trigger Revalidation or Tech Transfers

Using CPV Outcomes to Trigger Revalidation or Tech Transfers Using CPV Outcomes to Trigger Revalidation or Tech Transfers Step 1: Understanding the Basics of Sterilisation Validation Sterilisation validation is a crucial aspect of the pharmaceutical manufacturing process, ensuring that products…

CPV Template and Checklist for QA Teams

CPV Template and Checklist for QA Teams CPV Template and Checklist for QA Teams Continued Process Verification (CPV) is a critical component of process validation within the pharmaceutical industry. Emphasized by regulatory guidelines such as the FDA Process Validation Guidance…

How to Present CPV Data During Regulatory Audits

How to Present CPV Data During Regulatory Audits How to Present CPV Data During Regulatory Audits In the current regulatory landscape, the pharmaceutical industry faces stringent scrutiny regarding the implementation and effectiveness of Continued Process Verification (CPV) programs. This article…

CPV and OOS/OOT Events: Investigation Flow and Records

CPV and OOS/OOT Events: Investigation Flow and Records CPV and OOS/OOT Events: Investigation Flow and Records In the pharmaceutical industry, Continued Process Verification (CPV) and the effective management of Out of Specification (OOS) and Out of Trend (OOT) events are…