computer validation in pharmaceutical industry

GDP Compliance and Cold Chain Documentation Requirements

GDP Compliance and Cold Chain Documentation Requirements GDP Compliance and Cold Chain Documentation Requirements In the pharmaceutical industry, ensuring the integrity of products transported via cold chain logistics is vitally important. This comprehensive guide aims to provide a clear, step-by-step…

Stability Data Use in Excursion Impact Justification

Stability Data Use in Excursion Impact Justification Stability Data Use in Excursion Impact Justification The proper handling of temperature excursions is a critical concern in the pharmaceutical industry, particularly for products that require strict temperature controls during transport and storage.…

CAPA Plans Triggered by Cold Chain Deviations

CAPA Plans Triggered by Cold Chain Deviations CAPA Plans Triggered by Cold Chain Deviations Cold chain management is pivotal in the pharmaceutical industry, especially for temperature-sensitive products. Deviations in temperature during the transport of these products can lead to significant…

How to Perform Light Transmission and Moisture Permeation Testing

How to Perform Light Transmission and Moisture Permeation Testing How to Perform Light Transmission and Moisture Permeation Testing 1. Understanding User Requirements and Risk Assessment The first step in the validation lifecycle of light transmission and moisture permeation testing is…

Real-Time Data Capture Validation on Packaging Lines

Real-Time Data Capture Validation on Packaging Lines Real-Time Data Capture Validation on Packaging Lines This article provides a comprehensive, step-by-step guide on the validation lifecycle for real-time data capture systems used on packaging lines in the pharmaceutical industry. Given the…

Regulatory Guidelines for Traceability and Coding Compliance

Regulatory Guidelines for Traceability and Coding Compliance Regulatory Guidelines for Traceability and Coding Compliance The regulatory landscape for traceability and coding compliance in the pharmaceutical industry emphasizes the necessity for robust validation processes, especially concerning computer systems. This tutorial will…

EMA Annex 1 and HVAC Design for Aseptic Processing Areas

EMA Annex 1 and HVAC Design for Aseptic Processing Areas EMA Annex 1 and HVAC Design for Aseptic Processing Areas In the pharmaceutical industry, compliance with regulatory requirements is paramount in ensuring the safety and efficacy of medicinal products. One…

Interlock Testing Between Doors and HVAC Control

Interlock Testing Between Doors and HVAC Control Interlock Testing Between Doors and HVAC Control The pharmaceutical industry operates under stringent regulations that demand high standards of quality and compliance. This article provides a comprehensive step-by-step tutorial on conducting interlock testing…

Calibration of HVAC Sensors for Velocity, Temperature, and RH

Calibration of HVAC Sensors for Velocity, Temperature, and RH Calibration of HVAC Sensors for Velocity, Temperature, and RH Ensuring the environmental conditions in pharmaceutical manufacturing facilities is critical to maintaining product integrity and compliance. The calibration of HVAC sensors for…

How to Version Control Your Validation Protocols and Reports

How to Version Control Your Validation Protocols and Reports How to Version Control Your Validation Protocols and Reports In the highly regulated pharmaceutical and medical device industries, maintaining rigorous standards for validation documentation is critical. This article provides a comprehensive…