FDA – Page 298 – Pharma.Tips

Texture Variability during shared equipment campaign: GMP investigation and CAPA strategy

Investigating Texture Variability in Shared Equipment Campaigns: Identifying Causes and Implementing CAPA In the realm of pharmaceutical manufacturing, maintaining the quality of topical and dermatological dosage forms is paramount. One…

Drug Crystallization after backing material change: GMP investigation plan and CAPA

Understanding Drug Crystallization Following Changes to Backing Material: An Effective Investigation Framework In the pharmaceutical sector, changes in materials can yield unexpected issues, such as drug crystallization, particularly when dealing…

E&L Failure during method transfer: sampling, filtration, and EM controls

Addressing E&L Failures during Method Transfers: A Structured Investigation Approach During method transfers in pharmaceutical manufacturing, specifically in the production of ophthalmic dosage forms, extraction and leachable (E&L) failures can…

Ph Drift during homogenization: mixing and sampling controls for QA review

Understanding pH Drift During Homogenization and Ensuring Robust Mixing Controls for QA Review In pharmaceutical manufacturing, maintaining consistent product quality is critical for regulatory compliance and patient safety. One frequent…

Backing Delamination at accelerated stability: process parameter review and validation impact

Investigating Backing Delamination at Accelerated Stability: A Systematic Approach Backing delamination in transdermal drug delivery systems can significantly impact product integrity, therapeutic efficacy, and regulatory compliance. When delamination occurs during…

Viscosity Drift during bulk hold: GMP investigation and CAPA strategy

Addressing Viscosity Drift during Bulk Hold: A Comprehensive Investigation and CAPA Framework In pharmaceutical manufacturing, viscosity is a critical parameter that directly impacts the quality and performance of topical and…

Edge Lifting after adhesive change: root cause mapping across materials and process

Root Cause Analysis of Edge Lifting Following Adhesive Change in Transdermal Systems The phenomenon of edge lifting after adhesive change is a significant quality issue within transdermal drug delivery systems.…

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

Ccit Failure During Method Transfer: An Investigation Framework for Pharma Professionals Failure in Cell Culture Infectivity Testing (CCIT) during method transfer can pose significant challenges in pharmaceutical manufacturing, especially within…

E&L Failure after backing material change: GMP investigation plan and CAPA

Devising an Effective GMP Investigation for E&L Failure Following Backing Material Change In the realm of pharmaceutical manufacturing, the integrity and efficacy of transdermal drug delivery systems hinge on meticulous…

Emulsion Inversion after packaging change: cleaning validation and worst-case selection

Understanding Emulsion Inversion Post-Packaging Change: A Comprehensive Investigation Emulsion inversion often presents a significant challenge in pharmaceutical manufacturing, particularly after a change in packaging materials or design. Such incidents can…

Drug Crystallization during EU/UK market supply: process parameter review and validation impact

Understanding Drug Crystallization Challenges in EU/UK Market Supply: A Process Parameter Review In the pharmaceutical industry, ensuring the stability and integrity of drug products is paramount, particularly during the supply…

Assay Oos in cream manufacturing: GMP investigation and CAPA strategy

Investigating Assay Out-of-Specification in Cream Manufacturing: A GMP Approach In the realm of pharmaceutical manufacturing, particularly within cream manufacturing, the identification of out-of-specification (OOS) results can lead to significant challenges.…