Quality Systems – Page 257

Particle Size Distribution Oos in MDI assembly: device qualification and crimp validation controls

Addressing Out of Specification Issues in Particle Size Distribution During MDI Assembly Particle size distribution (PSD) is critical in the assembly of Metered Dose Inhalers (MDIs). Out of Specification (OOS)…

Leakage Failure during method transfer: device qualification and crimp validation controls

Investigating Leakage Failures During Method Transfer in Pharmaceutical Manufacturing Leakage failures during method transfer, particularly related to aerosol formulations, represent a significant challenge in pharmaceutical manufacturing. These failures can adversely…

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…

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