FDA – Page 299 – Pharma.Tips

E&L Failure during lamination: inspection-ready documentation pack

Investigation of E&L Failure in Lamination: A Guide for Compliance and Quality Assurance Managing Extractables and Leachables (E&L) failures during the lamination process in pharmaceutical manufacturing is critical. Such failures…

Pet Failure during method transfer: FDA-ready investigation report and batch disposition

Investigation Report on Pet Failure During Method Transfer: Ensuring Compliance and Quality Assurance In the realm of pharmaceutical manufacturing, method transfers for ophthalmic dosage forms pose significant challenges. A recent…

Cleaning Validation Failure during bulk hold: how to document deviations for FDA/EMA

Understanding and Documenting Cleaning Validation Failures during Bulk Hold In the dynamic world of pharmaceutical manufacturing, ensuring compliance with cleaning validation protocols during bulk hold operations is crucial. A failure…

Packaging Dry-Out after adhesive change: process parameter review and validation impact

Investigating Packaging Dry-Out After an Adhesive Change: A Structured Approach In pharmaceutical manufacturing, the integrity and performance of packaging materials are critical to product quality. A recent deviation encountered during…

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…