Tag: Quality Systems

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…

Steps for Investigating Tablet Lamination during High-Speed Manufacturing Runs Tablet lamination—a defect characterized by the formation of a layer or film on the surface of tablets—can significantly impact product efficacy…

Addressing Lamination Issues in Tablet Tech Transfer: A Comprehensive Investigation Approach Lamination of tablets during tech transfer is a significant issue that can result in out-of-specification (OOS) findings, impacting quality…

GMP Investigation Procedures for Blend Segregation during High-Speed Runs In the context of pharmaceutical manufacturing, blend segregation is a critical issue, especially during high-speed runs of solid oral dosage forms…

Addressing Sticking and Picking Issues for FDA Inspection Readiness: Essential Investigation Steps and Batch Disposition In pharmaceutical manufacturing, sticking and picking during the processing of solid oral dosage forms pose…