FDA – Page 283 – Pharma.Tips

Microbial Limits Failure during method transfer: GMP documentation for FDA/EMA/MHRA review

Addressing Microbial Limits Failures During Method Transfer in Pharmaceutical Manufacturing In the pharmaceutical industry, microbial limits testing is a critical component of ensuring product safety and quality. A microbial limits…

Propellant–Formulation Incompatibility during method transfer: device qualification and crimp validation controls

Understanding Propellant–Formulation Incompatibility during Method Transfer: A Detailed Investigation Approach In the pharmaceutical manufacturing realm, particularly within aerosol formulations, issues with propellant–formulation incompatibility can arise during method transfers. These complications…

Leakage Failure during method transfer: FDA/MHRA inspection-ready documentation

Addressing Leakage Failure during Method Transfer in Pharmaceutical Manufacturing In pharmaceutical manufacturing, maintaining the integrity of dosage forms is crucial, particularly during method transfers from development to production. One common…

Viscosity Drift at accelerated stability: sampling and mixing controls for QA review

Addressing Viscosity Drift in Accelerated Stability Testing: A Systematic Investigation Viscosity drift observed during accelerated stability testing is a critical concern in the pharmaceutical industry, especially for dental dosage forms.…

Assay Oos in ear drop manufacturing: manufacturing vs lab root cause decision tree

Root Cause Analysis for Out of Specification Assays in Ear Drop Manufacturing Out of Specification (OOS) assays can pose significant challenges in the manufacturing of pharmaceutical products, particularly for delicate…

Ph Drift after packaging change: packaging compatibility and shelf-life justification

Investigating pH Drift Post-Packaging Change: Strategies for Ensuring Compatibility and Stability In the pharmaceutical manufacturing environment, a pH drift following a packaging change can present significant challenges, particularly regarding product…

Phase Separation during method transfer: sampling and mixing controls for QA review

Analyzing Phase Separation Occurrences During Method Transfer: A Comprehensive Guide for Quality Assurance Review Phase separation in pharmaceutical manufacturing can significantly impact quality, particularly during method transfer processes. This article…

Viscosity Drift during inspection readiness: GMP documentation for FDA/EMA/MHRA review

Understanding and Addressing Viscosity Drift for Regulatory Compliance In the realm of pharmaceutical manufacturing, one common challenge encountered during the inspection readiness phase is viscosity drift. This deviation can lead…

Texture Grittiness Complaint after packaging change: sampling and mixing controls for QA review

Investigation into Texture Grittiness Complaints Following a Packaging Change In pharmaceutical manufacturing, quality complaints such as texture grittiness can indicate underlying issues that can impact product quality and patient satisfaction.…

Tube Leakage Complaint during method transfer: packaging compatibility and shelf-life justification

Investigation of Tube Leakage Complaints during Method Transfer: Ensuring Packaging Compatibility and Justifying Shelf Life In the realm of pharmaceutical manufacturing, particularly within the domain of dosage forms, tube leakage…

E&L Failure after supplier change: sampling and mixing controls for QA review

E&L Failures Post-Supplier Change: Implementing Robust Sampling and Mixing Controls When a supplier is changed in pharmaceutical manufacturing, it can lead to significant risks, including extractables and leachables (E&L) failures.…

Assay Oos after supplier change: GMP documentation for FDA/EMA/MHRA review

Investigating Assay Out of Specification Following Supplier Change in GMP Environments In the complex landscape of pharmaceutical manufacturing, a change in supplier can introduce unexpected variability that may culminate in…