EMA – Page 186 – Pharma.Tips

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…

Method Transfer Failure for innovative delivery systems: how to document for FDA/EMA/MHRA review

Addressing Method Transfer Failures in Innovative Delivery Systems: A Regulatory Perspective In the constantly evolving landscape of pharmaceutical manufacturing, method transfer failures can significantly impede the progress of innovative delivery…

Post-Approval Change Failure for modified release platforms: risk assessment and validation impact analysis

Assessing Post-Approval Change Failures in Modified Release Platforms: An Investigation Guide In the fast-evolving landscape of pharmaceutical manufacturing, the introduction of modified release platforms significantly enhances therapeutic efficacy. However, post-approval…

API nitrosamine risk exceedance after equipment maintenance intervention: GMP investigation checklist and batch disposition evidence pack

Investigating API Nitrosamine Risk Exceedance Post Maintenance: A GMP Checklist In the pharmaceutical manufacturing environment, equipment maintenance is critical but can inadvertently pose risks such as the exceedance of nitrosamine…

Sedimentation Oos during inspection readiness: manufacturing vs lab root cause decision tree

Investigating Sedimentation OOS During Inspection Readiness in Pharmaceutical Manufacturing In the highly regulated field of pharmaceutical manufacturing, out-of-specification (OOS) results can trigger a cascade of challenges, especially during inspection readiness.…