Tag: validation in pharma company

Defining “Pass” vs “Fail” in Validation Report Outcomes

Defining “Pass” vs “Fail” in Validation Report Outcomes Defining “Pass” vs “Fail” in Validation Report Outcomes The validation process is critical for ensuring the quality and safety of pharmaceutical products. Properly distinguishing between “pass” and “fail” outcomes in validation reports…

Linking Reports to Protocols: Cross-Referencing Best Practices

Linking Reports to Protocols: Cross-Referencing Best Practices Linking Reports to Protocols: Cross-Referencing Best Practices In the pharmaceutical industry, ensuring compliance with stringent regulatory standards is critical for quality assurance (QA) and validation teams. The process validation lifecycle comprises several pivotal…

Handling Shared Equipment and Systems in a Multi-Product VMP

Handling Shared Equipment and Systems in a Multi-Product VMP Handling Shared Equipment and Systems in a Multi-Product VMP The validation lifecycle in the pharmaceutical industry is a structured process aimed at ensuring that products are consistently produced and controlled according…

Common Roadblocks in VMP Execution and How to Overcome Them

Common Roadblocks in VMP Execution and How to Overcome Them Common Roadblocks in VMP Execution and How to Overcome Them Step 1: Understanding the Validation Lifecycle in Pharma Validation in pharma companies is a structured process that encompasses several key…

Reviewing the VMP During Annual Product Reviews (APR/PQR)

Reviewing the VMP During Annual Product Reviews (APR/PQR) Reviewing the VMP During Annual Product Reviews (APR/PQR) The validation lifecycle in a pharmaceutical company is crucial for ensuring compliance with regulatory standards and maintaining product quality. The Validation Master Plan (VMP)…

How to Detect and Report Data Integrity Breaches

How to Detect and Report Data Integrity Breaches How to Detect and Report Data Integrity Breaches Data integrity is a critical component in the validation lifecycle of pharmaceutical processes. This article outlines a comprehensive, step-by-step tutorial for the detection and…

How to Handle Electronic Record Migration and Archiving

How to Handle Electronic Record Migration and Archiving How to Handle Electronic Record Migration and Archiving Step 1: Understand Regulatory Requirements and Framework In the validation lifecycle of a pharma company, understanding regulatory requirements is paramount. Regulatory guidance documents such…

Time Stamp Synchronization and Record Authenticity

Time Stamp Synchronization and Record Authenticity Time Stamp Synchronization and Record Authenticity Validation in pharma companies is an essential aspect of ensuring compliance with regulatory standards. This article provides a detailed, step-by-step tutorial on the critical components of validation, focusing…

HVAC Equipment Qualification: AHU, Filters, Sensors

HVAC Equipment Qualification: AHU, Filters, Sensors HVAC Equipment Qualification: AHU, Filters, Sensors In the pharmaceutical industry, the validation of HVAC (Heating, Ventilation, and Air Conditioning) systems is crucial for ensuring a controlled environment that meets regulatory and operational standards. This…

How to Define Criticality for Legacy Equipment

How to Define Criticality for Legacy Equipment How to Define Criticality for Legacy Equipment In today’s highly regulated pharmaceutical landscape, defining the criticality of legacy equipment is essential for maintaining compliance with FDA, EMA, and other regulatory requirements. This tutorial…