EMA – Page 163 – Pharma.Tips

Finished product nitrosamine risk assessment gap after method transfer to a new QC lab: risk assessment for patient impact and field alert / recall triggers

Assessing Risks from Nitrosamines in Finished Products Post Method Transfer to a New QC Laboratory The pharmaceutical industry faces stringent regulatory expectations, particularly concerning the presence of nitrosamines in finished…

Assay drift during shared facility campaign: containment CAPA and effectiveness checks

Investigation into Assay Drift during a Shared Facility Campaign: A Step-by-Step Guide for Effective Containment and CAPA In a pharmaceutical manufacturing environment, assay drift can become a significant issue, particularly…

E&L Failure in MDI assembly: E&L risk assessment and documentation

E&L Failures in MDI Assembly: Comprehensive Investigative Approach In the realm of pharmaceutical manufacturing, particularly within the inhalation and nasal dosage forms sector, understanding and managing extractables and leachables (E&L)…

Finished product disintegration failure during complaint trending review: how to build a deviation package that passes an inspection deep-dive

“`html Addressing Finished Product Disintegration Failures During Complaints Trending: A Comprehensive Deviation Investigation Guide In the pharmaceutical industry, finished product disintegration failure can pose significant challenges, especially when trending complaints…

Cross-contamination risk during shared facility campaign: containment CAPA and effectiveness checks

Managing Cross-Contamination Risks in Shared Facility Campaigns: Effective Containment and CAPA Strategies Cross-contamination within shared pharmaceutical manufacturing facilities poses significant risks to product integrity and patient safety. When multiple products…

Cascade Impactor Setup Error at stability pull: FDA/MHRA investigation and corrective actions

Investigating Cascade Impactor Setup Errors at Stability Pulls: Insights for FDA and MHRA Compliance When a cascade impactor setup error occurs during stability pulls, the ramifications can be significant, affecting…

Finished product blend uniformity failure during recall risk assessment: manufacturing vs lab root cause mapping and required evidence

Investigating Finished Product Blend Uniformity Failure in Recall Risk Assessments When a pharmaceutical manufacturer faces a finished product blend uniformity failure during a recall risk assessment, it poses significant risks…

Assay drift during stability pull: FDA/EMA investigation expectations

Understanding Assay Drift during Stability Pulls: Investigation Framework and Strategy In pharmaceutical manufacturing, assay drift during stability pull represents a critical concern that can undermine the integrity of stability studies…

Apsd Oos in DPI manufacturing: method variability vs true product failure assessment

Investigating Apsd Oos in DPI Manufacturing: Distinguishing Method Variability from True Product Failures A deviation resulting in Out of Specification (OOS) results in dry powder inhalation (DPI) manufacturing can cause…

Finished product fill weight / volume variability after equipment calibration drift found: FDA-compliant investigation flow and batch disposition decision tree

Addressing Variability in Finished Product Fill Weight/Volume after Equipment Calibration Drift In pharmaceutical manufacturing, precision is paramount. Variability in finished product fill weight or volume can pose significant risks, including…

Occupational exposure limit breach during stability pull: risk assessment for patient safety

“`html Assessing Occupational Exposure Limit Breaches During Stability Pulls in Pharmaceutical Manufacturing In the highly regulated pharmaceutical industry, breaches of occupational exposure limits (OELs) during stability pulls can pose significant…

Pump Actuation Failure during inspection preparation: device qualification and assembly controls

Pump Actuation Failure during Inspection Preparation: A Comprehensive Investigation Approach In the regulated environment of pharmaceutical manufacturing, any deviations can lead to significant challenges. One common issue that can impede…