Quality Systems – Page 272

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…

Phase Separation during EU/UK market supply: how QA should write CAPA for inspectors

CAPA Strategies for Phase Separation in Liquid Oral Dosage Forms in the EU/UK Market In pharmaceutical manufacturing, particularly within the liquid oral dosage form sector, phase separation can result in…

Color Change On Stability in oral suspension manufacturing: investigation flowchart aligned to GMP

Investigating Color Change in Stability of Oral Suspensions: A GMP-Compliant Approach In pharmaceutical manufacturing, especially with liquid formulations such as oral suspensions, any deviation from expected product characteristics can signal…

Assay Oos in syrup production: manufacturing vs lab root cause decision tree

Understanding Assay OOS in Syrup Production: A Decision Tree for Root Cause Analysis Unexpected out-of-specification (OOS) results in assay testing during syrup production can significantly disrupt pharmaceutical operations. Such deviations…

Microbial Limits Failure after supplier change: mixing, sampling, and hold-time controls

Understanding Microbial Limits Failure Following Supplier Change: A Comprehensive Investigation Approach In the pharmaceutical manufacturing landscape, changes in suppliers can lead to a variety of quality assurance challenges, particularly concerning…

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