FDA – Page 301 – Pharma.Tips

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).…

Edge Lifting at accelerated stability: GMP investigation plan and CAPA

Investigating Edge Lifting in Transdermal Drug Delivery Systems Under Accelerated Stability Edge lifting presents a significant challenge in the realm of transdermal drug delivery systems, particularly during accelerated stability testing.…

Phase Separation in cream manufacturing: GMP investigation and CAPA strategy

GMP Investigation and CAPA Strategy for Phase Separation in Cream Manufacturing Phase separation in cream manufacturing is a critical quality issue that can significantly impact product efficacy and safety. This…

Adhesion Failure during lamination: process parameter review and validation impact

Reviewing Process Parameters and Validation Impacts for Adhesion Failure during Lamination In the realm of pharmaceutical manufacturing, particularly in the production of transdermal drug delivery systems, adhesion failure during lamination…

Ph Drift in eye drop manufacturing: packaging integrity and CCIT justification

Investigating pH Drift Issues in Eye Drop Manufacturing: Ensuring Packaging Integrity and CCIT Justification pH drift during eye drop manufacturing presents a significant concern that can compromise product quality and…

Tube Leakage Complaint in cream manufacturing: packaging compatibility and stability justification

Addressing Tube Leakage Issues in Cream Manufacturing: An Investigation Approach Tube leakage complaints in cream manufacturing can significantly impact product quality, patient satisfaction, and regulatory compliance. When a packaging component…