Deviation – Page 195

Fill Volume Variability during EU/UK market supply: water system and sanitation checks

Understanding Fill Volume Variability in EU and UK Market Supply: A Root Cause Investigation Fill volume variability is a pressing issue that can significantly impact the compliance and quality of…

Weight Variation during tech transfer: process parameter limits and validation impacts

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 Failure during CPV review: GMP investigation steps and batch disposition

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…

Oot Dissolution Trend during FDA inspection readiness: root cause analysis with CAPA evidence pack

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…

Content Uniformity Oos during compression: sampling plan fixes to avoid repeat OOS

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…

Weight Variation during high-speed runs: tooling, granulation, and lubrication troubleshooting

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…

Weight Variation after scale-up: root cause analysis with CAPA evidence pack

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…

Capsule Shell Brittleness during tech transfer: root cause analysis with CAPA evidence pack

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 Failure during tech transfer: how to document to meet FDA/EMA expectations

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…

Oot Dissolution Trend during tech transfer: process parameter limits and validation impacts

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…

Blend Segregation during CPV review: root cause analysis with CAPA evidence pack

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.…

Hardness Drift after maintenance: GMP investigation steps and batch disposition

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…