Tag: pharma QA

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…

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…

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…

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…

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…

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…