FDA – Page 300 – Pharma.Tips

Ph Drift during method transfer: FDA-ready investigation report and batch disposition

Investigation into pH Drift during Method Transfer: A Practical Approach for FDA-Ready Reporting In the complex world of pharmaceutical manufacturing, maintaining consistency and compliance during method transfers is critical. One…

Viscosity Drift after excipient change: packaging compatibility and stability justification

Investigating Viscosity Drift Following Excipient Change in Pharmaceutical Formulations Viscosity drift is a critical concern in the development and manufacturing of topical and dermatological dosage forms, particularly following an excipient…

Residual Solvent Oos at accelerated stability: GMP investigation plan and CAPA

Investigating Residual Solvent Out-of-Specification Findings During Accelerated Stability Studies Out-of-Specification (OOS) results regarding residual solvents during accelerated stability assessments can pose significant challenges in pharmaceutical manufacturing. Identifying the root causes…

Color Change during bulk hold: complaint trending and risk-based actions

Understanding Color Change During Bulk Hold: Investigation and Risk Mitigation Strategies In the pharmaceutical manufacturing realm, variations in product appearance, such as a color change during bulk hold, can signal…

Coating Weight Variability after adhesive change: inspection-ready documentation pack

Understanding and Investigating Coating Weight Variability After Changes in Adhesive Formulation Coating weight variability is a significant concern in pharmaceutical manufacturing, especially following a change in adhesive formulation. This variability…

E&L Failure after packaging change: packaging integrity and CCIT justification

Understanding E&L Failures Post-Packaging Changes: A Structured Investigation Approach In pharmaceutical manufacturing, especially within the realm of ophthalmic dosage forms, the integrity of packaging is crucial to product quality and…

Residual Solvent Oos after adhesive change: packaging integrity and shelf-life justification

Investigating Residual Solvent Out-of-Specification Results Following Adhesive Change In the realm of pharmaceutical manufacturing, a common challenge arises when an out-of-specification (OOS) result is reported for residual solvents following a…

Ph Drift during method transfer: how to document deviations for FDA/EMA

Addressing pH Drift during Method Transfer: A Comprehensive Investigation Guide for Regulatory Compliance Pharmaceutical manufacturing is a complex process where deviations, especially pH drift during method transfers, can have substantial…

E&L Failure during die-cutting: inspection-ready documentation pack

E&L Failure During Die-Cutting: Comprehensive Guide to Investigation and Action In pharmaceutical manufacturing, especially in the production of transdermal drug delivery systems, Extractables and Leachables (E&L) failures during the die-cutting…

Emulsion Inversion after packaging change: complaint trending and risk-based actions

Understanding Emulsion Inversion Following a Packaging Change: A Deep Dive into Investigative Methods In the realm of pharmaceutical manufacturing, emulsion inversion presents a significant challenge, especially after a packaging change.…

Residual Solvent Oos during lamination: GMP investigation plan and CAPA

Investigating Residual Solvent OOS During Lamination: A GMP Approach The occurrence of out-of-specification (OOS) results related to residual solvents during the lamination process can raise significant concerns in pharmaceutical manufacturing…

Fill Volume Variability during method transfer: sampling, filtration, and EM controls

Addressing Variability in Fill Volume during Method Transfer: A Practical Investigation Variability in fill volume during method transfer can lead to significant challenges in pharmaceutical manufacturing, particularly in the production…