Tag: sterilisation validation

Spreadsheet Validation in Pharma: Step-by-Step Guide

Spreadsheet Validation in Pharma: Step-by-Step Guide Spreadsheet Validation in Pharma: Step-by-Step Guide In the pharmaceutical industry, the integrity and reliability of data generated through software applications, especially spreadsheets, is critical. This article outlines a comprehensive step-by-step guide for validating spreadsheet…

Annex 11 vs ALCOA+: Where They Intersect

Annex 11 vs ALCOA+: Where They Intersect Annex 11 vs ALCOA+: Where They Intersect This article provides a comprehensive step-by-step validation tutorial focusing on sterilisation validation in the context of regulatory frameworks such as GMP, FDA, and EMA. The content…

Writing an Equipment Qualification Protocol: Structure & Format

Writing an Equipment Qualification Protocol: Structure & Format Writing an Equipment Qualification Protocol: Structure & Format The validation of pharmaceutical equipment is crucial to ensure that it meets the requirements for safety, efficacy, and quality. This article presents a step-by-step…

Sample Utility Qualification Protocol Template

Sample Utility Qualification Protocol Template Sample Utility Qualification Protocol Template This article serves as a comprehensive guide on the sterilisation validation process in pharmaceutical settings, aligned with regulatory expectations from entities such as the FDA, EMA, and WHO. It outlines…

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…