Tag: gxp validation

Case Study: Excursion Impact on Biologics Shipment

Case Study: Excursion Impact on Biologics Shipment Case Study: Excursion Impact on Biologics Shipment This article provides a comprehensive, step-by-step tutorial on GxP validation relevant to the transport and cold chain validation of biologics, with a focus on deviation handling…

Integration of ERP and Serialization Systems in Validation

Integration of ERP and Serialization Systems in Validation Integration of ERP and Serialization Systems in Validation In the pharmaceutical industry, validation is a critical aspect of ensuring compliance with regulatory requirements and maintaining product integrity. This article serves as a…

Acceptance Criteria for Air Velocity and Flow Patterns

Acceptance Criteria for Air Velocity and Flow Patterns Acceptance Criteria for Air Velocity and Flow Patterns This article presents a comprehensive step-by-step tutorial on establishing acceptance criteria for air velocity and flow patterns within pharmaceutical environments, in line with GxP…

Review and Approval Logs: Ensuring Attributable and Contemporaneous Entries

Review and Approval Logs: Ensuring Attributable and Contemporaneous Entries Review and Approval Logs: Ensuring Attributable and Contemporaneous Entries In the realm of pharmaceutical validation, the integrity of documentation is paramount. Review and approval logs play a critical role in ensuring…

Real-Life 483s Related to VMP Deficiencies

Real-Life 483s Related to VMP Deficiencies Real-Life 483s Related to VMP Deficiencies In today’s highly regulated pharmaceutical environment, validation plays a critical role in ensuring that manufacturing processes, systems, and equipment meet stringent regulatory requirements. The Validation Master Plan (VMP)…

Macro and Formula Locking Techniques for GMP Spreadsheets

Macro and Formula Locking Techniques for GMP Spreadsheets Macro and Formula Locking Techniques for GMP Spreadsheets In the realm of pharmaceutical manufacturing and quality control, ensuring data integrity and compliance is paramount. Effective gxp validation plays a critical role in…

Protocol Deviations vs Incidents: What’s the Difference?

Protocol Deviations vs Incidents: What’s the Difference? Protocol Deviations vs Incidents: What’s the Difference? In the pharmaceutical industry, ensuring compliance with regulatory standards is paramount. This tutorial serves as a step-by-step guide for QA, QC, Validation, and Regulatory teams, focusing…

How to Define Acceptance Criteria in Validation Documents

How to Define Acceptance Criteria in Validation Documents How to Define Acceptance Criteria in Validation Documents GxP validation is a critical aspect of pharmaceutical development and manufacturing that ensures quality, safety, and efficacy of products. A key component of this…