computer system validation in pharmaceuticals

Preparing for a Cold Chain Audit: What Inspectors Look For

Preparing for a Cold Chain Audit: What Inspectors Look For Preparing for a Cold Chain Audit: What Inspectors Look For Step 1: Understanding the Cold Chain Requirements In the pharmaceutical and biologics industry, maintaining product integrity during transport is of…

Communication Protocols for In-Transit Excursions

Communication Protocols for In-Transit Excursions Communication Protocols for In-Transit Excursions In the pharmaceutical industry, ensuring the integrity and compliance of products throughout the supply chain is essential. This is particularly true for temperature-sensitive products that require strict adherence to specified…

Common Excursion Causes and How to Prevent Them

Common Excursion Causes and How to Prevent Them Common Excursion Causes and How to Prevent Them 1. Understanding User Requirements Specifications (URS) and Risk Assessment The first step in the validation lifecycle of computer system validation in pharmaceuticals is to…

Simulating Transportation Conditions for Packaging-Product Stability

Simulating Transportation Conditions for Packaging-Product Stability Simulating Transportation Conditions for Packaging-Product Stability The validation of packaging systems is critical in ensuring the stability and integrity of pharmaceutical products throughout their lifecycle, particularly during transportation. This article provides a comprehensive, step-by-step…

Case Study: Batch Recall Due to Serialization System Failure

Case Study: Batch Recall Due to Serialization System Failure Case Study: Batch Recall Due to Serialization System Failure This detailed article serves as a practical guide for pharmaceutical professionals focusing on computer system validation in pharmaceuticals. It aims to improve…

Software Validation for Serialization Control Systems

Software Validation for Serialization Control Systems Software Validation for Serialization Control Systems In the pharmaceutical industry, proper computer system validation (CSV) is crucial for ensuring compliance with regulatory requirements and quality standards. Serialization control systems represent a significant aspect of…

WHO HVAC Guidelines for Non-Sterile and Sterile Facilities

WHO HVAC Guidelines for Non-Sterile and Sterile Facilities WHO HVAC Guidelines for Non-Sterile and Sterile Facilities The validation of HVAC systems is critical in maintaining the quality and integrity of pharmaceutical products. This article provides a comprehensive step-by-step guide on…

Airflow Requalification After Major Equipment Change

Airflow Requalification After Major Equipment Change Airflow Requalification After Major Equipment Change In the highly regulated pharmaceutical industry, maintaining the integrity of environmental controls is paramount. Airflow in controlled environments must be precisely managed, particularly after major equipment changes. This…

Relationship Between Filter Life, Pressure Drop, and Airflow

Relationship Between Filter Life, Pressure Drop, and Airflow Relationship Between Filter Life, Pressure Drop, and Airflow The pharmaceutical industry relies heavily on effective HVAC systems to maintain product quality and compliance with regulatory standards. Understanding the interconnectedness of filter life,…

Validation Documentation Retention Policy: What’s Required?

Validation Documentation Retention Policy: What’s Required? Validation Documentation Retention Policy: What’s Required? In the highly regulated pharmaceutical and medical device industries, maintaining proper validation documentation is paramount. This comprehensive guide outlines the necessary steps for an effective validation lifecycle, emphasizing…