MHRA – Page 213 – Pharma.Tips

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…

Sedimentation Rate Oos in oral suspension manufacturing: how QA should write CAPA for inspectors

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…

Microbial Limits Failure during filling line setup: packaging and transport risk assessment

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.…

Sedimentation Rate Oos at accelerated stability: mixing, sampling, and hold-time controls

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…

Hold Time Bioburden Rise during method transfer: mixing, sampling, and hold-time controls

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…

Crystallization In Syrup in oral suspension manufacturing: mixing, sampling, and hold-time controls

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…

Hold Time Bioburden Rise during method transfer: water system and sanitation checks

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…