Quality Systems – Page 241

API color / appearance change during stability pull at 6/12 months: supplier qualification gaps and incoming testing upgrades to close the loop

Investigating API Color Changes During Stability Pulls: Addressing Supplier Qualification Gaps In the lifecycle of Active Pharmaceutical Ingredients (APIs), color and appearance stability is a critical quality attribute. Unexpected deviations,…

Aseptic manipulation deviation during FDA inspection readiness: patient safety impact and disposition

Aseptic Manipulation Deviation Analysis for FDA Inspection Readiness: Ensuring Patient Safety and Compliance Aseptic manipulation deviations present serious challenges during FDA inspections, particularly due to their implications for patient safety…

Fine Particle Fraction Drift during EU/UK launch supply: FDA/MHRA investigation and corrective actions

Investigating Fine Particle Fraction Drift for EU/UK Launch Supply: A Deep Dive into FDA/MHRA Contexts In the pharmaceutical manufacturing landscape, issues such as fine particle fraction drift can pose significant…

Stability Failure for long-acting injectables: control strategy build-out for inspections

Addressing Stability Failures in Long-Acting Injectables: Building a Control Strategy for Inspections Stability failures in long-acting injectables pose significant challenges in pharmaceutical manufacturing, potentially disrupting the entire supply chain and…

Method Transfer Failure during lifecycle management: control strategy build-out for inspections

Addressing Method Transfer Failures in Lifecycle Management for Inspection Readiness In pharmaceutical manufacturing, method transfer failures can lead to significant compliance risks during inspections by regulatory bodies like the FDA,…

E&L Failure for long-acting injectables: regulatory-ready investigation and CAPA plan

Investigation and CAPA Planning for E&L Failure in Long-Acting Injectables Extractables and leachables (E&L) failures in long-acting injectables can jeopardize product quality and patient safety, posing significant challenges for pharmaceutical…

API hygroscopicity-driven degradation after re-crystallization parameter adjustment: risk-based approach to prevent repeat OOS across future API batches

“`html Investigating API Degradation: How to Mitigate Risks from Re-Crystallization Adjustments In pharmaceutical manufacturing, particularly concerning Active Pharmaceutical Ingredients (APIs), maintaining product integrity through proper processes is critical. One common…

Cell viability failure during ATMP manufacturing: regulatory risk assessment and CAPA

Assessing Cell Viability Failures in ATMP Manufacturing: A Systematic Investigation Approach Cell viability failures during the manufacturing of Advanced Therapy Medicinal Products (ATMPs) pose significant regulatory risks and can lead…

Pump Actuation Failure during EU/UK launch supply: device qualification and assembly controls

Pump Actuation Failure Investigation During EU/UK Launch Supply In the rapidly evolving landscape of pharmaceutical manufacturing, pump actuation failures can critically impede the successful launch of products, especially in highly…

Control Strategy Weakness for long-acting injectables: control strategy build-out for inspections

Identifying and Addressing Control Strategy Weaknesses in Long-Acting Injectables In the realm of pharmaceutical manufacturing, the integrity of the control strategy is paramount, especially for complex dosage forms like long-acting…

Oos Release Profile during lifecycle management: regulatory-ready investigation and CAPA plan

Investigation of OOS Release Profiles in Lifecycle Management: A Regulatory-Ready Approach The presence of Out-of-Specification (OOS) results during the lifecycle management of pharmaceutical products poses significant challenges for manufacturing and…

API residual palladium OOS during process validation campaign: how to write a defensible deviation narrative for inspections

Addressing OOS Results for API Residual Palladium During Process Validation Campaigns In the pharmaceutical manufacturing landscape, delivering high-quality active pharmaceutical ingredients (APIs) is paramount. When an out-of-specification (OOS) result for…