Quality Systems – Page 261

Assay Oos after excipient change: packaging compatibility and stability justification

Investigation of Assay OOS Following Excipient Change: Justifying Packaging Compatibility and Stability In pharmaceutical manufacturing, the occurrence of an out-of-specification (OOS) result can trigger complex investigations involving a multitude of…

Dropper Compatibility Failure during aseptic filling: sampling, filtration, and EM controls

Assessing Dropper Compatibility Failures During Aseptic Filling: A Structured Investigation Approach In the highly regulated environment of pharmaceutical manufacturing, deviations can have significant repercussions. This article addresses the investigation of…

Assay Oos during bulk hold: GMP investigation and CAPA strategy

Investigation and CAPA Approach for Assay OOS during Bulk Hold In pharmaceutical manufacturing, deviation reports relating to Out of Specification (OOS) assays during bulk holds can present significant challenges that…

Cleaning Validation Failure after excipient change: GMP investigation and CAPA strategy

Investigation of Cleaning Validation Failures After Excipient Changes in Pharmaceutical Manufacturing In the pharmaceutical manufacturing environment, ensuring compliance with Good Manufacturing Practices (GMP) is paramount, particularly when making changes in…

Dropper Compatibility Failure at stability pull: FDA-ready investigation report and batch disposition

Addressing Dropper Compatibility Failures During Stability Testing: A Comprehensive Investigation Framework In pharmaceutical manufacturing, ensuring the integrity of dosage forms is paramount, especially when dealing with components such as droppers…

Assay Oos in cream manufacturing: cleaning validation and worst-case selection

Deviations in Assay in Cream Manufacturing: Strategies for Effective Cleaning Validation and Worst-Case Selection In pharmaceutical manufacturing, particularly in the production of creams, Out of Specifications (OOS) results for assay…

Air Entrapment during bulk hold: cleaning validation and worst-case selection

Investigating Air Entrapment Issues in Bulk Holds: A Focus on Cleaning Validation and Worst-Case Selection In pharmaceutical manufacturing, especially in the production of topical and dermatological dosage forms, air entrapment…

Media Fill Failure after packaging change: FDA-ready investigation report and batch disposition

Investigation into Media Fill Failures Post Packaging Change Manufacturing professionals in the pharmaceutical sector often encounter challenges when introducing changes, especially related to packaging. A media fill failure, particularly after…

Phase Separation at accelerated stability: cleaning validation and worst-case selection

Understanding Phase Separation at Accelerated Stability: A Comprehensive Investigation Framework In the pharmaceutical manufacturing process, ensuring product quality and stability is paramount. One significant issue that can arise is phase…

Texture Variability in ointment filling: how to document deviations for FDA/EMA

Investigating Texture Variability in Ointment Filling: Documenting Deviations for Regulatory Compliance Texture variability in ointment filling can lead to significant deviations, which, if not properly addressed, may result in critical…

Osmolality Oos during sterile filtration: packaging integrity and CCIT justification

Addressing Osmolality OOS during Sterile Filtration in Pharmaceutical Manufacturing In the rigorous environment of pharmaceutical manufacturing, ensuring product quality is paramount. A common issue that arises during quality checks is…

High Visual Inspection Reject Rate during routine EM trending: FDA/MHRA investigation narrative and batch impact

Investigation of High Visual Inspection Reject Rates in Routine Environmental Monitoring High visual inspection reject rates during routine environmental monitoring (EM) can pose significant challenges in pharmaceutical manufacturing, particularly for…