FDA – Page 286 – Pharma.Tips

Hold Time Bioburden Rise in otic suspension filling: packaging integrity and stability justification

Investigation of Hold Time Bioburden Rise in Otic Suspension Filling In the highly regulated environment of pharmaceutical manufacturing, the integrity of sterile products must be meticulously controlled. A recent incident…

Assay Oos during inspection readiness: QMS trending and complaint handling expectations

Investigating Assay OOS: Managing Compliance and Complaint Handling in Pharmaceutical Inspections During the manufacturing process of dental dosage forms, unexpected Out of Specification (OOS) results can arise, particularly concerning assay…

Texture Grittiness Complaint in dental gel manufacturing: manufacturing vs lab root cause assessment

Assessing Grittiness Complaints: Differentiating Between Manufacturing and Lab Root Causes in Dental Gel Production In pharmaceutical manufacturing, particularly within the dental gel segment, complaints regarding texture grittiness can pose serious…

Texture Grittiness Complaint during method transfer: packaging compatibility and shelf-life justification

Investigating Texture Grittiness Complaints During Method Transfer in Pharmaceutical Manufacturing In the highly regulated world of pharmaceutical manufacturing, texture complaints, such as grittiness, can pose significant challenges, particularly during method…

Pet Failure at accelerated stability: packaging integrity and stability justification

Addressing Packaging Integrity and Stability Justification Issues in Pet Products During Accelerated Stability Tests In the realm of pharmaceutical manufacturing, particularly within dosage forms such as otic formulations, identifying and…

E&L Failure after supplier change: packaging compatibility and shelf-life justification

Addressing E&L Failures Following Supplier Adjustments in Pharmaceutical Manufacturing The pharmaceutical sector is no stranger to challenges, particularly when it comes to ensuring the compatibility of packaging materials with drug…

Viscosity Drift during bulk hold: GMP investigation steps with CAPA

Addressing Viscosity Drift Issues During Bulk Hold: An Investigation Framework Viscosity drift during bulk hold poses significant challenges in pharmaceutical manufacturing, particularly for dosage forms such as dental preparations. Deviations…

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.…