Quality Systems – Page 274

Phase Separation in ointment filling: complaint trending and risk-based actions

Investigating Phase Separation During Ointment Filling: A Problem-Solving Approach Phase separation in ointment filling can lead to significant quality failures and regulatory risks. When this issue arises, it not only…

E&L Failure during lamination: GMP investigation plan and CAPA

GMP Guidelines for Investigating E&L Failures During Lamination In pharmaceutical manufacturing, especially within transdermal drug delivery systems, extractables and leachables (E&L) failures during the lamination process can compromise product integrity…

E&L Failure at stability pull: sampling, filtration, and EM controls

Investigating E&L Failures During Stability Pulls: A Practical Guide In pharmaceutical manufacturing, especially when dealing with ophthalmic dosage forms, extracting the appropriate product for stability pulls is crucial to ensure…

Ivrt Failure during die-cutting: GMP investigation plan and CAPA

Investigation Plan and CAPA for Ivrt Failures During Die-Cutting In the complex realm of pharmaceutical manufacturing, the integrity of dosage forms is paramount, especially for transdermal delivery systems. A common…

Fill Weight Variability in cream manufacturing: mixing and sampling controls for QA review

Addressing Fill Weight Variability in Cream Manufacturing: Effective Mixing and Sampling Controls Fill weight variability in cream manufacturing represents a critical quality concern that can lead to operational inefficiencies, regulatory…

Coating Weight Variability after adhesive change: GMP investigation plan and CAPA

Managing Variability in Coating Weight Post-Adhesive Change: A GMP Investigation Framework Coating weight variability following an adhesive change poses a significant challenge in pharmaceutical manufacturing, particularly within transdermal drug delivery…

Viscosity Drift during homogenization: how to document deviations for FDA/EMA

Documenting Deviations Due to Viscosity Drift During Homogenization for Regulatory Compliance Viscosity drift during the homogenization process poses significant challenges within pharmaceutical manufacturing, particularly for topical and dermatological formulations. This…

Edge Lifting during EU/UK market supply: process parameter review and validation impact

Addressing Edge Lifting During EU/UK Market Supply: Process Parameter Review and Validation Considerations Edge lifting in transdermal drug delivery systems (TDDS) can present significant challenges during the EU/UK market supply…

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…