EMA – Page 226 – Pharma.Tips

Viscosity Drift during method transfer: manufacturing vs lab root cause decision tree

Understanding Viscosity Drift during Method Transfer: A Decision Tree for Root Cause Analysis Viscosity drift during the method transfer process can lead to significant challenges in pharmaceutical manufacturing, potentially resulting…

Assay Oos during method transfer: investigation flowchart aligned to GMP

Investigating Assay OOS During Method Transfer: A Structured Flowchart for Compliance The occurrence of Out-of-Specification (OOS) results during assay method transfer represents a critical challenge for pharmaceutical manufacturers. This scenario…

Ph Drift during filling line setup: packaging and transport risk assessment

Assessing pH Drift During Filling Line Setup: A Comprehensive Investigation Approach The pharmaceutical manufacturing sector is no stranger to the challenges of maintaining product quality during the filling process, particularly…

Density Mismatch during bulk hold: packaging and transport risk assessment

Addressing Density Mismatch Risks During Bulk Hold in Pharmaceutical Manufacturing Density mismatch incidents during bulk hold can pose significant risks in pharmaceutical manufacturing, particularly in the packaging and transport stages…

Microbial Limits Failure after temperature excursion: investigation flowchart aligned to GMP

Investigative Workflow for Microbial Limits Failure Post Temperature Excursion In the pharmaceutical manufacturing environment, temperature excursions can pose significant risks, particularly concerning microbial limits. When microbial limits fail following a…

Foaming And Air Entrapment during filling line setup: manufacturing vs lab root cause decision tree

Understanding Foaming and Air Entrapment during Filling Line Setup: A Root Cause Investigation Framework Foaming and air entrapment issues during filling line setup are common challenges faced in pharmaceutical manufacturing,…

Microbial Limits Failure during filling line setup: mixing, sampling, and hold-time controls

Investigating Microbial Limits Failures During Filling Line Setup: Key Actions to Ensure Compliance In pharmaceutical manufacturing, maintaining stringent microbial limits during the filling line setup is crucial for ensuring product…

Fill Volume Variability during filling line setup: investigation flowchart aligned to GMP

Investigating Variability in Fill Volumes during Filling Line Setup Aligned with GMP Standards The pharmaceutical manufacturing process is critical in ensuring drug efficacy and safety, particularly in liquid oral dosage…

Ph Drift during bulk hold: water system and sanitation checks

Understanding pH Drift during Bulk Hold: Essential Checks for Water Systems and Sanitation In the pharmaceutical manufacturing landscape, maintaining product quality during the bulk holding periods is critical. One significant…

Sedimentation Rate Oos after temperature excursion: packaging and transport risk assessment

Sedimentation Rate Oos Following Temperature Excursions: Comprehensive Risk Assessment in Packaging and Transport In the pharmaceutical manufacturing sector, deviations such as Out-of-Specification (OOS) results pertaining to sedimentation rates can pose…

Hold Time Bioburden Rise after supplier change: water system and sanitation checks

Investigating the Rise of Hold Time Bioburden Following Supplier Changes in Pharmaceutical Water Systems In the realm of pharmaceutical manufacturing, maintaining stringent bioburden limits is critical, particularly in water systems…

Preservative Under-Dosing in syrup production: manufacturing vs lab root cause decision tree

Investigating Preservative Under-Dosing in Syrup Production: Manufacturing and Laboratory Root Cause Decision Trees Preservative under-dosing in syrup production poses a significant risk not only to product safety but also to…