Tag: EMA

Assessing Filling Volume Variability in Syrup Production: Investigation and Risk Mitigation Fill volume variability in syrup production can significantly affect product quality and compliance. Variability leading to out-of specification (OOS)…

Investigating Assay OOS at Accelerated Stability: Packaging and Transport Risk Assessment In pharmaceutical manufacturing, Out of Specification (OOS) results can pose significant challenges, particularly concerning stability testing. One area of…

Addressing Homogeneity Issues Post Supplier Change: A Comprehensive Investigation Approach In pharmaceutical manufacturing, maintaining product homogeneity is critical, especially following a supplier change. A failure in homogeneity can lead to…

Addressing Microbial Limits Failures in Syrup Production: A Comprehensive Investigation Approach Microbial limits failures can present significant challenges in the production of liquid oral dosage forms such as syrups. Such…

Investigating Foaming and Air Entrapment during Bulk Hold: A Risk Assessment for Packaging and Transport In pharmaceutical manufacturing, the integrity and quality of liquid oral dosage forms are paramount. One…

Investigation Flowchart for Color Change on Stability during EU/UK Market Supply Color change in liquid oral dosage forms such as syrups and suspensions during stability studies can indicate underlying issues…

Addressing Fill Volume Variability Following a Supplier Change: Effective Strategies for Control and Compliance In the realm of pharmaceutical manufacturing, particularly when dealing with liquid oral dosage forms, maintaining consistent…

Addressing Viscosity Drift in Filling Line Setup: A Comprehensive Approach for Quality Assurance Viscosity drift during the filling line setup can significantly impact the quality and safety of liquid oral…

Conducting an Investigation into Microbial Limits Failure following Supplier Change Changes in suppliers can significantly impact microbial limits within pharmaceutical manufacturing processes. When a microbial limits failure arises after a…

Understanding and Investigating Homogeneity Failures during Bulk Hold Homogeneity failures during bulk holds of liquid oral dosage forms like syrups and suspensions are critical issues that can compromise product quality…

Addressing Color Change on Stability During Bulk Hold: A Practical Investigation Guide In the realm of pharmaceutical manufacturing, deviations such as unexpected color changes during stability testing can pose substantial…

Assessing pH Drift Risks Following Supplier Changes in Pharmaceutical Manufacturing In pharmaceutical manufacturing, changes to suppliers can introduce unforeseen variability, particularly when it comes to formulation components like pH-sensitive excipients…