Tag: sterilisation validation

How to Handle Temperature Excursions in Pharma Shipments

How to Handle Temperature Excursions in Pharma Shipments How to Handle Temperature Excursions in Pharma Shipments Step 1: Understanding Temperature Excursions and Regulatory Expectations Temperature excursions refer to deviations from the predefined temperature ranges that must be maintained during the…

Data Integrity and Part 11 Compliance for Digital Devices

Data Integrity and Part 11 Compliance for Digital Devices Data Integrity and Part 11 Compliance for Digital Devices Ensuring compliance with regulatory standards for digital devices in the pharmaceutical industry is crucial for maintaining data integrity, particularly during sterilisation validation…

How to Validate a Serialization System: Pharma Industry Guide

How to Validate a Serialization System: Pharma Industry Guide How to Validate a Serialization System: Pharma Industry Guide Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first phase in the validation lifecycle for a serialization system begins…

Packaging Line Clearance and Line Reconciliation Validation

Packaging Line Clearance and Line Reconciliation Validation Packaging Line Clearance and Line Reconciliation Validation Packaging line clearance and line reconciliation validation are critical components in the pharmaceutical manufacturing cycle. These processes ensure that packaging systems operate optimally, preventing cross-contamination and…

HEPA Filter Integrity Testing: DOP/PAO Method Explained

HEPA Filter Integrity Testing: DOP/PAO Method Explained HEPA Filter Integrity Testing: DOP/PAO Method Explained In the pharmaceutical and biotechnology industries, ensuring the integrity of HEPA filters is critical for maintaining aseptic environments. The DOP (di-octyl phthalate) and PAO (polyalphaolefin) methods…

Microbial Recovery Limits Based on Cleanroom Grades

Microbial Recovery Limits Based on Cleanroom Grades Microbial Recovery Limits Based on Cleanroom Grades In the pharmaceutical and biotechnology industries, ensuring the integrity and sterility of products is of utmost importance. One crucial aspect influencing this integrity is the microbial…

What Is ALCOA+? A Data Integrity Framework for Validation Teams

What Is ALCOA+? A Data Integrity Framework for Validation Teams What Is ALCOA+? A Data Integrity Framework for Validation Teams Data integrity is a foundational aspect of regulated environments, particularly within the pharmaceutical and biotech sectors. The ALCOA+ framework enhances…

SOPs for Managing Cross-Referenced Validation Files

SOPs for Managing Cross-Referenced Validation Files SOPs for Managing Cross-Referenced Validation Files In today’s regulatory environment, effective management of cross-referenced validation files is crucial for ensuring compliance with quality standards. This article serves as a comprehensive step-by-step tutorial on sterilisation…

What Do Regulators Expect in a Validation Master Plan?

What Do Regulators Expect in a Validation Master Plan? What Do Regulators Expect in a Validation Master Plan? In the highly regulated pharmaceutical industry, the Validation Master Plan (VMP) plays a pivotal role in ensuring that products are developed and…

VMP Communication Plan for Internal and External Stakeholders

VMP Communication Plan for Internal and External Stakeholders VMP Communication Plan for Internal and External Stakeholders The integration of a robust Validation Master Plan (VMP) is crucial for pharmaceutical organizations, particularly in multi-product or contract manufacturing environments. This document serves…