Tag: Regulatory Compliance & Audit Readiness

Alignment with USP , ICH Q1A, and WHO TRS Guidelines

Alignment with USP, ICH Q1A, and WHO TRS Guidelines Alignment with USP, ICH Q1A, and WHO TRS Guidelines This article provides a comprehensive step-by-step validation tutorial specifically focused on ISO 11137-1, emphasizing the harmonization of medical device validation with relevant…

How to Create an Audit-Ready Validation File for Cold Chain

How to Create an Audit-Ready Validation File for Cold Chain How to Create an Audit-Ready Validation File for Cold Chain Creating an audit-ready validation file for cold chain management is essential for QA, QC, and regulatory teams in the pharmaceutical…

Common Audit Findings Related to Transport and Storage Conditions

Common Audit Findings Related to Transport and Storage Conditions Common Audit Findings Related to Transport and Storage Conditions Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The foundation of any effective validation process lies in a comprehensive User…

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…

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…

Regulatory Guidelines for Cold Chain Validation (FDA, WHO, EMA)

Regulatory Guidelines for Cold Chain Validation (FDA, WHO, EMA) Regulatory Guidelines for Cold Chain Validation (FDA, WHO, EMA) Cold chain validation is critical in the pharmaceutical and biologics industries to ensure product integrity during transport and storage. This comprehensive guide…