Tag: GMP compliance

Out-of-Trend (OOT) vs Out-of-Specification (OOS) in CPV

Out-of-Trend (OOT) vs Out-of-Specification (OOS) in CPV Out-of-Trend (OOT) vs Out-of-Specification (OOS) in CPV In the context of pharmaceutical manufacturing, maintaining quality control through continued process verification (CPV) is imperative. A critical aspect of CPV relates to the monitoring and…

Common Excursion Causes and How to Prevent Them

Common Excursion Causes and How to Prevent Them Common Excursion Causes and How to Prevent Them 1. Understanding User Requirements Specifications (URS) and Risk Assessment The first step in the validation lifecycle of computer system validation in pharmaceuticals is to…

Integration of SCADA/PLC Outputs into CPV Dashboards

Integration of SCADA/PLC Outputs into CPV Dashboards Integration of SCADA/PLC Outputs into CPV Dashboards In the pharmaceutical industry, the integration of SCADA (Supervisory Control and Data Acquisition) and PLC (Programmable Logic Controller) outputs into Continued Process Verification (CPV) dashboards is…

Regulatory Requirements for Excursion Investigations

Regulatory Requirements for Excursion Investigations Regulatory Requirements for Excursion Investigations In the pharmaceutical and biologics industries, ensuring the integrity and quality of products during transport and cold chain management is of utmost importance. This is especially relevant during situations involving…

Setting Statistical Action and Alert Limits in CPV

Setting Statistical Action and Alert Limits in CPV Setting Statistical Action and Alert Limits in CPV Continued Process Verification (CPV) is an essential component of the pharmaceutical validation lifecycle, intended to ensure that processes remain in a state of control…

Excursion Logging, Justification, and QA Approval

Excursion Logging, Justification, and QA Approval Excursion Logging, Justification, and QA Approval Temperature excursions during the transportation and storage of pharmaceuticals can significantly impact the safety and efficacy of the products. This article provides a comprehensive step-by-step tutorial focused on…

Real-Time Data Collection for Batch-to-Batch Consistency

Real-Time Data Collection for Batch-to-Batch Consistency Real-Time Data Collection for Batch-to-Batch Consistency Continued Process Verification (CPV) is essential in ensuring product quality and compliance in the pharmaceutical industry. Among its key elements is cleaning validation, which is critical to avoiding…

Decision Trees for Product Disposition After Excursion

Decision Trees for Product Disposition After Excursion Decision Trees for Product Disposition After Excursion The pharmaceutical industry faces numerous challenges in maintaining compliance with regulations regarding the transport and storage of products, particularly when dealing with temperature excursions. Addressing these…

CPV Data Sources: MES, LIMS, BMRs, and Manual Logs

CPV Data Sources: MES, LIMS, BMRs, and Manual Logs CPV Data Sources: MES, LIMS, BMRs, and Manual Logs Continued Process Verification (CPV) has become an essential part of the pharmaceutical manufacturing lifecycle, allowing companies to ensure that their processes remain…

Deviation Trending in Cold Chain Management

Deviation Trending in Cold Chain Management Deviation Trending in Cold Chain Management In the pharmaceutical and biologics sectors, effective deviation trending within cold chain management is essential for ensuring the integrity of products subjected to temperature variations. This article provides…