Quality Systems – Page 247

API nitrosamine risk exceedance after milling / micronization change: risk-based approach to prevent repeat OOS across future API batches

Managing API Nitrosamine Risk Exceedance Post-Milling Change: An Effective Investigation Approach The emergence of nitrosamine risk exceedance following a milling or micronization process change poses significant challenges in the pharmaceutical…

Phase Separation after supplier change: GMP documentation for FDA/EMA/MHRA review

Addressing Phase Separation Issues Due to Supplier Changes: A Comprehensive Investigation Guide In pharmaceutical manufacturing, the introduction of a new supplier can pose significant challenges, including product quality deviations like…

Control Strategy Weakness after formulation change: decision tree for lab vs manufacturing root cause

Addressing Control Strategy Weakness Following a Formulation Change: A Decision-Making Framework for Root Cause Investigation In the dynamic environment of pharmaceutical manufacturing, formulation changes can often trigger unexpected control strategy…

E&L Failure for long-acting injectables: how to document for FDA/EMA/MHRA review

Documenting E&L Failures in Long-Acting Injectables for Regulatory Review As the pharmaceutical industry embraces advanced drug delivery systems such as long-acting injectables, the risk of element and leachables (E&L) failures…

Cpv Trending Gap for nanoformulations: decision tree for lab vs manufacturing root cause

Investigation Into Cpv Trending Gap for Nanoformulations: A Structured Approach to Root Cause Analysis In the realm of pharmaceutical manufacturing, particularly when dealing with advanced nanoformulations, the emergence of gaps…

API nitrosamine risk exceedance after cleaning validation requalification: GMP investigation checklist and batch disposition evidence pack

Checklist for Investigating API Nitrosamine Risk Exceedance Post-Cleaning Validation Requalification The identification of API nitrosamine risk exceedance after a cleaning validation requalification presents a significant challenge in pharmaceutical manufacturing. Such…

Preservative Miscalculation during inspection readiness: sanitation, water, and EM checks

Addressing Preservative Miscalculation During Inspection Readiness In the pharmaceutical manufacturing landscape, the precision of preservative calculations is vital, particularly during the inspection readiness phase. An oversight in this area can…

Oos Release Profile after formulation change: how to document for FDA/EMA/MHRA review

Documenting OOS Release Profiles Following Formulation Changes: A Guide for Compliance and Investigation In the pharmaceutical manufacturing landscape, deviations such as Out-of-Specification (OOS) results post-formulation change present complex challenges. These…

Scale-Up Failure after formulation change: control strategy build-out for inspections

Addressing Scale-Up Failure Following a Formulation Change: Building a Robust Control Strategy for Inspections In the highly regulated field of pharmaceutical manufacturing, scale-up failures following formulation changes pose significant risks…

API assay drift during CPV trending review: regulatory impact assessment and change control remediation plan

Assessing API Assay Drift during CPV Trending Review and its Regulatory Implications In the pharmaceutical manufacturing landscape, monitoring critical performance variables (CPV) is paramount for ensuring product quality and compliance.…

Assay Oos during bulk hold: investigation steps with CAPA evidence

Steps for Investigating Assay OOS during Bulk Holds in Pharmaceutical Manufacturing In the complex landscape of pharmaceutical manufacturing, encountering an Out of Specification (OOS) result during an assay for bulk-held…

Cpv Trending Gap after formulation change: decision tree for lab vs manufacturing root cause

Understanding Cpv Trending Gaps Post-Formulation Changes: A Decision-Making Guide for Investigations In pharmaceutical manufacturing, formulation changes are essential for product improvement and adaptation to regulatory requirements. However, they may also…