ICH – Page 135 – Pharma.Tips

Crystallization In Syrup during bulk hold: how QA should write CAPA for inspectors

Understanding Crystallization in Syrups During Bulk Hold: A Guide for Quality Assurance CAPA Crystallization in syrup formulations during the bulk holding process presents a critical challenge in pharmaceutical manufacturing, particularly…

Hold Time Bioburden Rise during EU/UK market supply: mixing, sampling, and hold-time controls

Addressing Bioburden Issues During Hold Time in EU/UK Pharmaceutical Supply Chains In the pharmaceutical manufacturing sector, maintaining product quality is paramount, especially for liquid oral dosage forms such as syrups…

Color Change in cream manufacturing: GMP investigation and CAPA strategy

Investigating Color Change in Cream Manufacturing: A Comprehensive GMP Approach Color changes in cream manufacturing can indicate significant quality issues, leading to Out of Specification (OOS) results and potential regulatory…

Foaming And Air Entrapment after temperature excursion: water system and sanitation checks

Investigating Foaming and Air Entrapment Issues Following Temperature Excursion in Pharmaceutical Water Systems Temperature excursions in pharmaceutical manufacturing can lead to significant process deviations, particularly in liquid oral dosage forms…

Phase Separation after temperature excursion: water system and sanitation checks

Exploring Phase Separation Post Temperature Excursion: Essential Water System and Sanitation Checks In the complex landscape of pharmaceutical manufacturing, maintaining the integrity of liquid oral dosage forms is critical, especially…

Emulsion Inversion after excipient change: mixing and sampling controls for QA review

Understanding and Addressing Emulsion Inversion Following Excipient Modifications In the pharmaceutical manufacturing arena, an unexpected occurrence like emulsion inversion can pose significant challenges, particularly after changes in excipients. Such incidents…

Assay Oos after temperature excursion: how QA should write CAPA for inspectors

Addressing Assay OOS Following Temperature Excursion: A Comprehensive CAPA Approach for QA Teams In pharmaceutical manufacturing, deviations such as Out of Specification (OOS) results can arise from various factors, including…

Density Mismatch in syrup production: packaging and transport risk assessment

Evaluating Density Mismatch in Syrup Production: A Comprehensive Investigation Approach In pharmaceutical manufacturing, challenges such as density mismatch during syrup production can lead to significant quality concerns, impacting both product…

Sedimentation Rate Oos during filling line setup: mixing, sampling, and hold-time controls

Sedimentation Rate OOS Investigation During Filling Line Setups In the realm of pharmaceutical manufacturing, deviations such as Out-of-Specification (OOS) results for sedimentation rates during filling line setups can lead to…

Fill Volume Variability in syrup production: packaging and transport risk assessment

Assessing Filling Volume Variability in Syrup Production: Investigation and Risk Mitigation Fill volume variability in syrup production can significantly affect product quality and compliance. Variability leading to out-of specification (OOS)…

Assay Oos at accelerated stability: packaging and transport risk assessment

Investigating Assay OOS at Accelerated Stability: Packaging and Transport Risk Assessment In pharmaceutical manufacturing, Out of Specification (OOS) results can pose significant challenges, particularly concerning stability testing. One area of…

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

Addressing Homogeneity Issues Post Supplier Change: A Comprehensive Investigation Approach In pharmaceutical manufacturing, maintaining product homogeneity is critical, especially following a supplier change. A failure in homogeneity can lead to…