Tag: EMA

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…

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…

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…

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…

Managing Sedimentation Rate OOS in Oral Suspension Production: A Comprehensive CAPA Approach for QA Teams In the complex landscape of pharmaceutical manufacturing, deviations such as out-of-specification (OOS) results can pose…

Investigating Microbial Limits Failure During Filling Line Setup: A Step-by-Step Approach The pharmaceutical manufacturing landscape can be complex, and ensuring microbial limits compliance during filling line setup poses significant challenges.…

Addressing Sedimentation Rate OOS Issues during Accelerated Stability in Pharmaceutical Manufacturing In the realm of pharmaceutical manufacturing, Out of Specification (OOS) results for sedimentation rates during accelerated stability studies can…

Identifying the Root Causes of Hold Time Bioburden Rise during Method Transfer In the complex landscape of pharmaceutical manufacturing, maintaining product quality throughout processes is critical. A recent investigation into…

Investigating Crystallization Issues in Syrup Production for Oral Suspensions Crystallization during the manufacturing of oral suspensions can present significant challenges, potentially leading to quality deviations and non-compliance with Good Manufacturing…

Addressing the Rise in Hold Time Bioburden During Method Transfers in Pharmaceutical Manufacturing In the pharmaceutical industry, maintaining product quality is paramount. A recent signal of concern has emerged regarding…

Investigating Fill Volume Variability after Temperature Excursion in Pharmaceutical Packaging In the regulated world of pharmaceutical manufacturing, even minor deviations can lead to significant implications. One such scenario is fill…

Understanding Fill Volume Variability in EU and UK Market Supply: A Root Cause Investigation Fill volume variability is a pressing issue that can significantly impact the compliance and quality of…