Quality Systems – Page 245

Hold Time Bioburden Rise after supplier change: manufacturing vs lab root cause decision tree

Investigation of Hold Time Bioburden Increase Following Supplier Change: A Decision Tree Approach The rise in bioburden levels observed during hold time after changing a supplier can pose significant concerns…

Viscosity Drift in dental gel manufacturing: packaging compatibility and shelf-life justification

Investigation into Viscosity Drift in Dental Gel Manufacturing: Ensuring Packaging Compatibility and Shelf-Life Justification Viscosity drift during the manufacturing of dental gels poses a significant challenge in maintaining product quality…

Phase Separation after supplier change: manufacturing vs lab root cause assessment

Investigating Phase Separation after a Change in Supplier: A Manufacturing and Laboratory Perspective Phase separation is a critical issue in pharmaceutical manufacturing, particularly when a change in supplier occurs. This…

Content Uniformity Failure after packaging change: packaging compatibility and shelf-life justification

Addressing Content Uniformity Failure Following a Packaging Change: An Investigation Approach In pharmaceutical manufacturing, ensuring consistent content uniformity is paramount, especially following changes to packaging. A deviation in content uniformity…

Fill Volume Variability during method transfer: manufacturing vs lab root cause decision tree

Addressing Variability in Fill Volume during Method Transfer: A Root Cause Investigation Framework Variability in fill volume during method transfer poses significant compliance and product quality challenges in pharmaceutical manufacturing.…

Tube Leakage Complaint in dental paste filling: sampling and mixing controls for QA review

Investigating Tube Leakage Complaints in Dental Paste Filling: A Practical Approach for QA Review Tube leakage complaints in dental paste filling operations can have significant implications for product quality and…

Assay Oos in dental paste filling: packaging compatibility and shelf-life justification

Investigation of Out-of-Specification Assays in Dental Paste Filling: Ensuring Packaging Compatibility and Shelf-Life Justification In the pharmaceutical manufacturing sector, particularly in the production of dental dosage forms, the emergence of…

Sedimentation Oos during inspection readiness: packaging integrity and stability justification

Addressing Sedimentation OOS during Inspection Readiness: Understanding Packaging Integrity and Stability In the realm of pharmaceutical manufacturing, especially within dosage forms like otic solutions, variations in sedimentation can trigger out-of-specification…

Pet Failure in dental paste filling: GMP investigation steps with CAPA

Addressing Pet Failures in Dental Paste Filling: A Comprehensive GMP Investigation Guide In the fast-paced world of pharmaceutical manufacturing, especially within dental dosage forms, encountering problems like pet failure during…

Content Uniformity Failure after packaging change: sampling and mixing controls for QA review

Addressing Content Uniformity Failures Following a Packaging Change In the dynamic landscape of pharmaceutical manufacturing, maintaining consistency and quality is paramount. A recent case involving a content uniformity failure after…

Ph Drift in dental paste filling: manufacturing vs lab root cause assessment

Root Cause Assessment for pH Drift in Dental Paste Filling: Manufacturing vs Lab Investigation The challenge of pH drift in dental paste filling can lead to significant complications in both…

Sedimentation Oos during inspection readiness: sanitation, water, and EM checks

Investigating Sedimentation OOS during Inspection Readiness: Key Focus Areas for Quality Assurance In the pharmaceutical manufacturing sector, maintaining compliance during inspection readiness is critical, especially concerning out-of-specification (OOS) findings. One…