Tag: EMA

Addressing Weight Variations during Technical Transfer: Key Insights and Investigation Strategies Weight variation during technical transfer can present significant challenges in pharmaceutical manufacturing. These variances can impact product quality, regulatory…

Dissolution Failures in CPV Reviews: Steps for GMP Investigation and Batch Disposition In the realm of pharmaceutical manufacturing, the failure of dissolution tests during the Continuous Process Verification (CPV) review…

Root Cause Analysis for Out of Trend Dissolution During FDA Inspection Preparation As pharmaceutical manufacturers, maintaining compliance and quality control is paramount. During preparation for FDA inspections, the emergence of…

Addressing Content Uniformity OOS during Compression: A Practical Investigation Guide In the pharmaceutical manufacturing environment, ensuring content uniformity during the compression of solid oral dosage forms is critical to maintaining…

Troubleshooting Weight Variation in High-Speed Runs: Investigative Approach Weight variation during high-speed runs can present significant challenges in pharmaceutical manufacturing, particularly for solid oral dosage forms such as tablets and…

Root Cause Analysis for Weight Variation after Scale-Up in Pharmaceutical Manufacturing In the pharmaceutical manufacturing environment, weight variation after scale-up can pose significant challenges in maintaining product quality and compliance…

Analyzing Capsule Shell Brittleness during Technology Transfer: A Root Cause Investigation In pharmaceutical manufacturing, the integrity of capsule shells is essential for product quality. When brittleness occurs during technology transfer,…

Dissolution Failures in Tech Transfer: Documenting for FDA and EMA Compliance Pharmaceutical companies frequently encounter challenges during the tech transfer process, particularly when it comes to ensuring consistent dissolution profiles…

Addressing Oot Dissolution Trends During Tech Transfer: Investigative Steps for Compliance In the pharmaceutical manufacturing sector, tech transfers can significantly impact product quality and operational efficiency. One common issue that…

Root Cause Analysis and CAPA Evidence for Blend Segregation during CPV Review Blend segregation in pharmaceutical manufacturing can lead to significant quality concerns, especially during Continued Process Verification (CPV) reviews.…

Investigative Steps for Hardness Drift Following Maintenance in Pharmaceutical Manufacturing In the highly regulated environment of pharmaceutical manufacturing, the integrity of product quality must be uncompromising. Hardness drift after maintenance…

Addressing Friability Failures in High-Speed Runs: A Comprehensive Investigation Guide In pharmaceutical manufacturing, friability failures represent a significant quality concern, particularly during high-speed runs of solid oral dosage forms such…