EMA – Page 166 – Pharma.Tips

Finished product appearance defect complaints during line clearance and changeover: how to defend specification setting and outlier handling during inspection

Understanding and Addressing Finished Product Appearance Defect Complaints During Line Clearance and Changeover The pharmaceutical manufacturing landscape often faces complexities during line clearance and product changeovers. Among these challenges, finished…

Cross-contamination risk during inspection prep: risk assessment for patient safety

Assessing Cross-Contamination Risks During Inspection Preparation in Pharma Manufacturing Cross-contamination risk during inspection preparation can pose significant challenges to pharmaceutical manufacturing, especially in sectors like oncology where patient safety is…

Fine Particle Fraction Drift during method transfer: device qualification and assembly controls

Exploring Ranges of Fine Particle Fraction Drift during Method Transfer: A Comprehensive Investigation In the realm of pharmaceutical manufacturing, particularly in inhalation and nasal dosage forms, deviations in fine particle…

Finished product particulate matter OOS during stability pull at accelerated conditions: stability strategy adjustments and packaging risk mitigation steps

Addressing Out-of-Specification Results for Particulate Matter in Finished Products during Stability Testing In pharmaceutical manufacturing, ensuring the quality and safety of finished products is paramount. One critical aspect of this…

Cross-contamination risk during stability pull: FDA/EMA investigation expectations

Understanding the Risks of Cross-Contamination during Stability Pulls in Pharmaceutical Manufacturing In pharmaceutical manufacturing, the integrity of product stability studies is paramount. One significant concern that can compromise these studies…

Fine Particle Fraction Drift after device supplier change: how to trend dose delivery data in CPV

Understanding Fine Particle Fraction Drift Following a Device Supplier Change In the landscape of pharmaceutical manufacturing, changes to suppliers can introduce unforeseen challenges, one of which is the drift in…

Finished product particulate matter OOS during line clearance and changeover: updates to master batch record and in-process controls to prevent recurrence

Addressing Out-of-Specification for Particulate Matter in Finished Products During Line Clearance and Changeover In the pharmaceutical manufacturing landscape, out-of-specification (OOS) events, particularly concerning particulate matter, are not uncommon during line…

Chain of identity breach during stability testing: regulatory risk assessment and CAPA

Assessing the Regulatory Risk of Stability Testing Identity Breaches and Implementing CAPA In the highly regulated field of pharmaceutical manufacturing, especially with complex medicinal products like Advanced Therapy Medicinal Products…

Leakage Complaint in nasal spray filling: device qualification and assembly controls

Addressing Leakage Issues in the Filling Process of Nasal Spray Devices In the competitive pharmaceutical landscape, maintaining high quality standards for drug delivery systems is non-negotiable. A recent complaint regarding…

Finished product transport excursion stability impact during deviation triage meeting: risk assessment for patient impact and field alert / recall triggers

Assessing Stability Impact During Finished Product Transport Excursions in Deviation Triage Meetings In the pharmaceutical manufacturing landscape, deviations related to finished product transport excursions can pose significant risks to product…

Aseptic manipulation deviation during stability testing: regulatory risk assessment and CAPA

Aseptic Manipulation Deviation During Stability Testing: A Comprehensive Investigation Guide Aseptic manipulation deviations during stability testing can pose significant regulatory risks and impact product integrity. These deviations can lead to…

Propellant Loss at stability pull: how to trend dose delivery data in CPV

Understanding Propellant Loss at Stability Pull: Optimizing Dose Delivery Data in Continuous Process Verification The industrial landscape of pharmaceutical manufacturing is fraught with challenges, particularly when it comes to the…