Tag: media fill

KPI Dashboard for QA Review of Validation Activities

KPI Dashboard for QA Review of Validation Activities KPI Dashboard for QA Review of Validation Activities In the highly regulated pharmaceutical environment, the validation of processes, cleaning, and computerized systems is critical to ensuring product quality and compliance. This article…

Case Study: CPV Detects Process Drift Before Batch Failure

Case Study: CPV Detects Process Drift Before Batch Failure Case Study: CPV Detects Process Drift Before Batch Failure In the biopharmaceutical industry, maintaining product quality and ensuring systemic consistency throughout the manufacturing process is paramount. Continued Process Verification (CPV) is…

Media Fill Frequency: When to Repeat and Why

Media Fill Frequency: When to Repeat and Why Media Fill Frequency: When to Repeat and Why In the pharmaceutical industry, ensuring product sterility is paramount, particularly for aseptically processed products. A critical aspect of this assurance is the performance of…

Revalidation SOP Template: Periodic, Planned & Emergency Changes

Revalidation SOP Template: Periodic, Planned & Emergency Changes Revalidation SOP Template: Periodic, Planned & Emergency Changes In the pharmaceutical industry, the importance of revalidation cannot be overstated. Revalidation ensures that processes remain in a state of control, fulfilling regulatory requirements…

Regulatory Expectations for Using Risk Tools in Validation

Regulatory Expectations for Using Risk Tools in Validation Regulatory Expectations for Using Risk Tools in Validation Validation in the pharmaceutical and biopharmaceutical industries is essential to ensure product quality, efficacy, and safety. A robust validation process adheres to established guidelines…

Interpreting Linearity Graphs in Chromatographic Methods

Interpreting Linearity Graphs in Chromatographic Methods Interpreting Linearity Graphs in Chromatographic Methods In the field of pharmaceutical sciences, ensuring the integrity and reliability of analytical methods is paramount. One crucial aspect of analytical method validation is the assessment of linearity,…

Microbial Monitoring in HVAC Ducts and Return Vents

Microbial Monitoring in HVAC Ducts and Return Vents Microbial Monitoring in HVAC Ducts and Return Vents The validation of HVAC systems, specifically focusing on microbial monitoring, is a crucial aspect of ensuring the quality and safety of pharmaceutical products during…

Regulatory Expectations for Holding Time Studies (FDA, EMA, WHO)

Regulatory Expectations for Holding Time Studies (FDA, EMA, WHO) Regulatory Expectations for Holding Time Studies (FDA, EMA, WHO) Holding time studies, integral to ensuring product safety and efficacy, are governed by stringent regulatory expectations. In the pharmaceutical world, the verification…