Quality Systems – Page 259

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…

Viscosity Drift during shared equipment campaign: GMP investigation and CAPA strategy

Investigation of Viscosity Drift During Shared Equipment Campaigns in Pharmaceutical Manufacturing During shared equipment campaigns in pharmaceutical manufacturing, deviations such as viscosity drift can signal significant risks to product quality…

Adhesion Failure in transdermal patch manufacturing: inspection-ready documentation pack

Investigating Adhesion Failures in Transdermal Patch Production: Comprehensive Documentation Strategies Adhesion failure is a critical concern in the manufacturing of transdermal patches, posing challenges that can lead to quality discrepancies…

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

Understanding and Documenting Viscosity Drift during Method Transfer in Pharmaceutical Manufacturing Viscosity drift during method transfer is a common challenge faced by pharmaceutical manufacturers, particularly in the production of topical…

Curling After Packaging after adhesive change: process parameter review and validation impact

Investigation of Curling Issues Post-Packaging Due to Adhesive Changes The pharmaceutical industry frequently encounters challenges relating to packaging, particularly when alterations to materials occur. One common issue that can arise…

Ccit Failure during sterile filtration: risk assessment for sterility assurance

Ccit Failure during Sterile Filtration: A Comprehensive Investigation Framework CCIT (Container Closure Integrity Testing) failures during sterile filtration processes can create significant risks for sterility assurance, particularly in the pharmaceutical…

Edge Lifting during die-cutting: root cause mapping across materials and process

An In-Depth Investigation into Edge Lifting during Die-Cutting in Pharmaceutical Manufacturing Edge lifting during die-cutting is a common yet critical deviation in the pharmaceutical manufacturing of transdermal drug delivery systems.…

Cleaning Validation Failure during method transfer: cleaning validation and worst-case selection

Investigation of Cleaning Validation Failures during Method Transfer: Practical Approaches In the realm of pharmaceutical manufacturing, cleaning validation is a critical component to ensure compliance with Good Manufacturing Practices (GMP).…