FDA – Page 302 – Pharma.Tips

Edge Lifting during lamination: process parameter review and validation impact

Reviewing Process Parameters and Validation Impact for Edge Lifting in Lamination In the complex realm of pharmaceutical manufacturing, edge lifting during lamination poses significant risks to product integrity and quality.…

Assay Oos during bulk hold: packaging compatibility and stability justification

Addressing Assay Out-of-Specification Results During Bulk Hold: A Comprehensive Investigation Approach Out-of-Specification (OOS) results for assays, particularly during bulk hold phases, can pose significant challenges in pharmaceutical manufacturing. Such occurrences…

Dropper Compatibility Failure during aseptic filling: FDA-ready investigation report and batch disposition

Investigating Dropper Compatibility Failures in Aseptic Filling: A Comprehensive Approach Dropper compatibility failures during aseptic filling can pose significant risks within pharmaceutical manufacturing environments, notably in the production of ophthalmic…

Ph Drift during method transfer: complaint trending and risk-based actions

Investigation of pH Drift During Method Transfer: Addressing Complaints and Implementing Risk-Based Actions pH drift during method transfer can significantly impact the quality and efficacy of pharmaceutical products, particularly in…

Tube Leakage Complaint after excipient change: packaging compatibility and stability justification

Investigating Tube Leakage Complaints Following Excipient Changes in Pharmaceutical Manufacturing In the pharmaceutical industry, changes in excipients can lead to unforeseen packaging issues, notably tube leakage. Such situations can compromise…

Ccit Failure after packaging change: how to avoid repeat 483 observations

Understanding Ccit Failures Post-Packaging Change: Preventing Future 483 Observations Certain types of pharmaceutical production encounters frequent challenges that can lead to observations from regulatory bodies like the FDA, EMA, or…

Emulsion Inversion during bulk hold: cleaning validation and worst-case selection

Addressing Emulsion Inversion during Bulk Hold: Key Investigation Strategies In the realm of pharmaceutical manufacturing, emulsion inversion during bulk hold can pose significant challenges. It not only threatens product integrity…

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…