Tag: oq iq pq

Real-Life Examples of Route Failures and Validation CAPA

Real-Life Examples of Route Failures and Validation CAPA Real-Life Examples of Route Failures and Validation CAPA The validation of transport routes for pharmaceuticals is a critical component of ensuring product integrity, efficacy, and safety. This comprehensive guide addresses the validation…

Validation of Blow-Fill-Seal (BFS) Packaging Systems

Validation of Blow-Fill-Seal (BFS) Packaging Systems Validation of Blow-Fill-Seal (BFS) Packaging Systems Validation of Blow-Fill-Seal (BFS) packaging systems is essential for ensuring that pharmaceutical products are safely packaged and remain effective throughout their shelf life. This step-by-step tutorial outlines the…

Building Management System (BMS) Integration with HVAC

Building Management System (BMS) Integration with HVAC Building Management System (BMS) Integration with HVAC This article serves as a comprehensive guide for pharmaceutical professionals focused on the essential processes of validation in HVAC systems. It provides detailed steps aligned with…

Documenting Acceptance Criteria and Test Methods in Protocols

Documenting Acceptance Criteria and Test Methods in Protocols Documenting Acceptance Criteria and Test Methods in Protocols In the pharmaceutical industry, thorough documentation of acceptance criteria and test methods in validation protocols is pivotal to ensure compliance with regulatory frameworks, including…

How to Include Risk Assessment Strategy Within a VMP

How to Include Risk Assessment Strategy Within a VMP How to Include Risk Assessment Strategy Within a VMP In the highly regulated pharmaceutical and biologics industries, the validation lifecycle is crucial to ensuring product safety, quality, and efficacy. The Validation…

Using GAMP 5 for Cloud-Based and SaaS Applications

Using GAMP 5 for Cloud-Based and SaaS Applications Using GAMP 5 for Cloud-Based and SaaS Applications This article provides a comprehensive step-by-step tutorial on using GAMP 5 principles for validating cloud-based and Software as a Service (SaaS) applications within the…

How to Link URS to DQ and Qualification Activities

How to Link URS to DQ and Qualification Activities How to Link URS to DQ and Qualification Activities In the pharmaceutical industry, ensuring the quality and compliance of manufacturing processes and equipment is of paramount importance. This is especially true…

How to Perform a Gap Assessment Before Stage 1 Qualification

How to Perform a Gap Assessment Before Stage 1 Qualification How to Perform a Gap Assessment Before Stage 1 Qualification In the pharmaceutical industry, ensuring that processes comply with stringent regulations is crucial for delivering safe and effective products. This…