Tag: EMA

Addressing Blend Segregation Challenges Following Scale-Up: Parameters and Validation Considerations Blend segregation can pose significant challenges during the scale-up of solid oral dosage forms in pharmaceutical manufacturing. The potential for…

GMP Investigation Steps for Content Uniformity OOS Following Stability Pull In pharmaceutical manufacturing, ensuring content uniformity is critical for both product quality and compliance. A post-stability pull that reveals an…

Addressing Capsule Fill Weight Variation for FDA Inspection Readiness: Troubleshooting Tooling, Granulation, and Lubrication In the pharmaceutical manufacturing landscape, variations in capsule fill weight can prompt significant regulatory scrutiny, particularly…

Steps to Investigate Blend Segregation Following an Excipient Change in Pharmaceuticals In pharmaceutical manufacturing, the integrity of blended materials is crucial for ensuring product quality. Blend segregation following an excipient…

Guidelines for Tablet Lamination Processes to Ensure FDA Inspection Readiness In the pharmaceutical industry, the lamination of tablets is a critical process that can significantly impact product quality and compliance.…

Addressing Hardness Drift Following Excipient Changes: A Comprehensive Investigative Approach In pharmaceutical manufacturing, the integrity and quality of solid oral dosage forms, particularly tablets and capsules, are paramount. A common…

Documenting and Investigating Blend Segregation Following an Excipient Change in Pharmaceutical Manufacturing Blend segregation can significantly impact the quality of solid oral dosage forms, especially following an excipient change. In…

Investigation Steps for Tablet Capping Issues during High-Speed Runs Tablet capping during high-speed runs can present significant challenges in pharmaceutical manufacturing, leading to product quality issues and potential regulatory scrutiny.…

Addressing Capsule Fill Weight Variation for Optimal FDA Inspection Readiness Variation in capsule fill weight is a crucial quality concern that can lead to Out of Specification (OOS) results and…

Addressing Content Uniformity OOS Issues for FDA Inspection Readiness: A Step-by-Step GMP Investigation Guide Content uniformity is a critical parameter in pharmaceutical manufacturing, particularly for solid oral dosage forms such…

Investigating Oot Dissolution Trends in Preparation for FDA Inspections: Steps to Ensure Compliance In the pharmaceutical manufacturing landscape, maintaining compliance with Good Manufacturing Practices (GMP) is critical, especially during pre-approval…

Investigating Blend Segregation in the Tech Transfer Process: A Comprehensive Guide In pharmaceutical manufacturing, the transfer of technology from development to production is crucial yet fraught with challenges. One such…