EMA – Page 165 – Pharma.Tips

Finished product fill weight / volume variability during routine batch release: stability strategy adjustments and packaging risk mitigation steps

Addressing Variability in Fill Weight and Volume During Routine Batch Releases In pharmaceutical manufacturing, achieving consistent fill weight and volume is critical for product quality and compliance. Variability in these…

Cross-contamination risk during stability pull: containment CAPA and effectiveness checks

Effective Investigation and Management of Cross-Contamination Risks During Stability Pulls Cross-contamination during stability pulls is a pressing concern in pharmaceutical manufacturing, particularly within oncology products. When stability samples are extracted,…

Fine Particle Fraction Drift at stability pull: device qualification and assembly controls

Objectively Investigating Fine Particle Fraction Drift During Stability Testing In the pharmaceutical industry, maintaining the quality of inhalation products through rigorous testing is paramount. A common issue that surfaces during…

Finished product fill weight / volume variability during routine batch release: how to build a deviation package that passes an inspection deep-dive

Understanding and Investigating Variability in Fill Weight and Volume during Finished Product Release In pharmaceutical manufacturing, maintaining consistent fill weight and volume is crucial for product integrity and compliance with…

Stability failure after equipment cleaning: containment CAPA and effectiveness checks

Addressing Stability Failures Post-Equipment Cleaning in Pharmaceutical Manufacturing In the realm of pharmaceutical manufacturing, ensuring product stability is paramount, particularly after equipment cleaning. A stability failure can have serious implications,…

Pump Actuation Failure at stability pull: method variability vs true product failure assessment

Pump Actuation Failure During Stability Pull: Navigating Method Variability and True Product Assessment The pharmaceutical industry is often faced with challenges that can disrupt the consistency and reliability of drug…

Finished product particulate matter OOS during EMA/MHRA inspection preparation: how to defend specification setting and outlier handling during inspection

Defending the Specification Setting and Handling Outliers for Finished Product Particulate Matter OOS During EMA/MHRA Inspections In the pharmaceutical manufacturing industry, achieving regulatory compliance and ensuring product quality are paramount.…

Cross-contamination risk during inspection prep: containment CAPA and effectiveness checks

Addressing Cross-Contamination Risks During Inspection Preparation: A Methodical Approach to Containment and CAPA Cross-contamination risks during inspection preparation can critically compromise product quality and regulatory compliance. This investigation-focused article aims…

Propellant Loss at stability pull: method variability vs true product failure assessment

Assessing Propellant Loss During Stability Pulls: Evaluating Method Variability Versus Actual Product Failure In pharmaceutical manufacturing, particularly within inhalation and nasal dosage forms, detecting a propellant loss during stability testing…

Finished product transport excursion stability impact during EMA/MHRA inspection preparation: updates to master batch record and in-process controls to prevent recurrence

Assessing Finished Product Transport Excursion Stability Impact for EMA/MHRA Inspections In the highly regulated environment of pharmaceutical manufacturing, transport excursions during the shipment of finished products can pose severe challenges,…

Cross-contamination risk during shared facility campaign: risk assessment for patient safety

Assessing the Risk of Cross-Contamination in Shared Facility Campaigns In the pharmaceutical manufacturing sector, particularly for oncology products, the risk of cross-contamination during shared facility campaigns poses significant challenges. The…

Cleaning Validation Gap after device supplier change: method variability vs true product failure assessment

Assessing Cleaning Validation Gaps Following a Device Supplier Transition In the pharmaceutical manufacturing sector, a reported cleaning validation gap following a device supplier change often leads to heightened scrutiny concerning…