IP – Page 10 – Pharma.Tips

Variability in excipient grade during regulatory review – CAPA for formulation failures

Investigating Variability in Excipient Grade During Regulatory Review The pharmaceutical industry relies heavily on excipients for drug formulation, and any variability during regulatory review can pose significant challenges. Understanding the…

Variability in excipient grade during formulation development – compatibility study expectations

Understanding Variability in Excipient Grades During Formulation Development In the pharmaceutical manufacturing process, variability in excipient grades can significantly impact drug formulation, leading to potential quality issues that attract scrutiny…

Functional performance failure during stability assessment – preventing late-stage reformulation

Understanding and Addressing Functional Performance Failures During Stability Assessments Functional performance failures during stability assessments pose significant risks to the pharmaceutical manufacturing process, potentially leading to late-stage reformulations or even…

Unjustified excipient choice during formulation development – CAPA for formulation failures

Addressing Unjustified Excipient Choices in Formulation Development: An Investigation Approach In pharmaceutical manufacturing, the selection of excipients during formulation development is crucial for ensuring product quality. Unjustified excipient choices can…

Variability in excipient grade during scale-up – regulatory scrutiny of excipient data

Understanding Variability in the Grade of Excipients During Scale-Up and Its Regulatory Implications As pharmaceutical professionals, we often encounter inconsistencies in excipients that can significantly affect the quality and performance…

Particle size variability impacts performance during supplier change – inspection questions regulators ask

How Particle Size Variability Affects Performance Following Supplier Changes The pharmaceutical industry frequently encounters the challenge of maintaining consistent product quality during supplier changes, especially regarding raw materials like Active…

Polymorphic form inconsistency during supplier change – inspection questions regulators ask

Investigation of Polymorphic Form Inconsistency During Supplier Transition in Pharmaceutical Manufacturing In the dynamic landscape of pharmaceutical manufacturing, polymorphic form inconsistency can lead to significant quality issues, particularly during a…

Residual solvent excursions during deviation investigation – regulatory impact assessment

Investigating Residual Solvent Excursions in Pharmaceutical Manufacturing In pharmaceutical manufacturing, ensuring compliance with quality standards for raw materials is critical. One common issue that can arise is the presence of…

Polymorphic form inconsistency during stability studies – regulatory impact assessment

Assessing Regulatory Impacts of Polymorphic Form Inconsistencies in Stability Studies In the pharmaceutical manufacturing environment, consistent polymorphic form is essential for ensuring that active pharmaceutical ingredients (APIs) meet their specifications…

Residual solvent excursions during stability studies – inspection questions regulators ask

Investigating Residual Solvent Excursions during Stability Studies: A Comprehensive Approach In pharmaceutical manufacturing, residual solvent excursions during stability studies can pose significant risks to product quality, compliance, and regulatory inspection…

Residual solvent excursions during supplier change – regulatory impact assessment

Addressing Residual Solvent Excursions During Supplier Changes: A Comprehensive Investigation In the pharmaceutical industry, excursions related to residual solvents during raw material supplier changes can present serious challenges, potentially impacting…

API assay variability exceeds trend limits during regulatory inspection – CAPA aligned to GMP expectations

Investigating API Assay Variability During Regulatory Inspection: A CAPA Approach Variability in Active Pharmaceutical Ingredient (API) assays that exceeds trend limits can pose significant challenges during regulatory inspections, raising concerns…