EP – Page 14 – Pharma.Tips

Particle size variability impacts performance during deviation investigation – preventing batch rejection and recall

Understanding How Particle Size Variability Affects Performance in Deviation Investigations Particle size variability in active pharmaceutical ingredients (APIs) can present significant challenges in pharmaceutical manufacturing, often leading to batch rejection…

Particle size variability impacts performance during regulatory inspection – preventing batch rejection and recall

Impact of Particle Size Variability on Regulatory Inspection Performance and Prevention Strategies In the highly regulated pharmaceutical industry, maintaining the quality of active pharmaceutical ingredients (APIs) and excipients is crucial…

Polymorphic form inconsistency during incoming testing – inspection questions regulators ask

Addressing Polymorphic Form Inconsistency in Incoming Testing: A Comprehensive Investigation Guide In pharmaceutical manufacturing, polymorphic forms of Active Pharmaceutical Ingredients (APIs) play a crucial role in determining product quality and…

Impurity profile drift detected during supplier change – inspection questions regulators ask

Investigating Impurity Profile Drift After Supplier Change: A Practical Guide In the pharmaceutical manufacturing landscape, supply chain changes can pose significant quality risks. A recent scenario has surfaced where an…

API assay variability exceeds trend limits during regulatory inspection – inspection questions regulators ask

Investigating API Assay Variability that Exceeds Trend Limits During Regulatory Inspections During a regulatory inspection, finding that API assay variability exceeds established trend limits can trigger significant concern. This situation…

API stability failure during supplier change – preventing batch rejection and recall

Investigative Approach to Addressing API Stability Failures During Supplier Changes When changing suppliers for Active Pharmaceutical Ingredients (APIs), unforeseen stability failures can jeopardize product integrity, potentially leading to batch rejection…

API stability failure during deviation investigation – CAPA aligned to GMP expectations

Analyzing API Stability Failures through Effective Deviation Investigation In the highly regulated field of pharmaceutical manufacturing, maintaining the stability of Active Pharmaceutical Ingredients (APIs) is crucial for ensuring product safety…

Particle size variability impacts performance during incoming testing – root cause investigation framework

Understanding the Impact of Particle Size Variability on Incoming Testing Performance In pharmaceutical manufacturing, maintaining stringent quality control during the acceptance testing of raw materials is critical to ensure product…

Impurity profile drift detected during regulatory inspection – preventing batch rejection and recall

Preventing Batch Rejection and Recall from Impurity Profile Drift During Regulatory Inspections During a recent regulatory inspection, a pharmaceutical manufacturing facility detected impurity profile drift in its active pharmaceutical ingredients…

API stability failure during stability studies – regulatory impact assessment

Investigation into API Stability Failures During Stability Studies and Their Regulatory Impact API stability failures during stability studies can lead to significant challenges in pharmaceutical manufacturing, quality control, and regulatory…

Pharmacopoeial Non-Compliance in Materials? USP EP IP Compliance Roadmap

Addressing Pharmacopoeial Non-Compliance in Materials: A Comprehensive Compliance Roadmap In pharmaceutical manufacturing, maintaining compliance with established pharmacopoeial standards is a significant challenge that can directly impact product safety and efficacy.…

API Quality Variability Problems? Supplier, Testing, and Control Strategy Solutions

Addressing API Quality Variability: Solutions for Supplier, Testing, and Control Challenges The production of active pharmaceutical ingredients (APIs) is a critical aspect of pharmaceutical manufacturing, yet quality variability is an…