MHRA – Page 186 – Pharma.Tips

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…

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

Investigating Content Uniformity Failures Post-Supplier Change: Strategies for Quality Assurance In the highly regulated environment of pharmaceutical manufacturing, content uniformity (CU) failures can pose significant challenges, particularly following a change…

E&L Failure in dental paste filling: GMP investigation steps with CAPA

GMP Investigation Steps for E&L Failure in Dental Paste Filling E&L (extractables and leachables) failure during the filling of dental pastes can lead to significant quality concerns and regulatory scrutiny.…

Phase Separation at accelerated stability: investigation steps with CAPA evidence

Steps to Investigate Phase Separation at Accelerated Stability in Otic Dosage Forms Phase separation in otic dosage forms during accelerated stability testing can indicate potential quality failures, leading to Out…