EMA – Page 161 – Pharma.Tips

Finished product assay OOS during deviation triage meeting: how to defend specification setting and outlier handling during inspection

Addressing Out-of-Specification Results in Finished Product Assays: A Structured Investigation Approach In pharmaceutical manufacturing, encountering an Out-of-Specification (OOS) result during the finished product assay can pose significant challenges. Such scenarios…

Occupational exposure limit breach during stability pull: containment CAPA and effectiveness checks

Addressing Occupational Exposure Limit Breaches During Stability Pulls: A Detailed Investigation Approach In pharmaceutical manufacturing, the integrity of processes and adherence to regulatory standards is paramount, especially during critical operations…

Residual Solvent Oos during scale-up: GMP investigation plan and CAPA

Investigating Residual Solvent OOS during Scale-up: A Comprehensive GMP Approach In pharmaceutical manufacturing, the detection of Out of Specification (OOS) results for residual solvents during the scale-up process poses significant…

Finished product packaging leakage complaint after packaging material change: manufacturing vs lab root cause mapping and required evidence

Addressing Finished Product Packaging Leakage Complaints Following Material Changes In the dynamic environment of pharmaceutical manufacturing, changes in packaging materials can sometimes lead to unexpected issues, such as finished product…

Stability failure during inspection prep: risk assessment for patient safety

“`html Understanding Stability Failures in Inspection Preparation: A Comprehensive Investigation Approach Stability failures during inspection preparation represent a significant risk to patient safety and regulatory compliance in the pharmaceutical industry.…

Backing Delamination during lamination: packaging integrity and shelf-life justification

Addressing Backing Delamination during Lamination: Ensuring Packaging Integrity and Shelf-Life Compliance Backing delamination during the lamination process in pharmaceutical manufacturing can compromise packaging integrity, potentially affecting product stability, efficacy, and…

Finished product nitrosamine risk assessment gap during PAI / FDA inspection readiness: risk assessment for patient impact and field alert / recall triggers

Assessing Gaps in Finished Product Nitrosamine Risk During PAI and FDA Inspection Readiness Pharmaceutical manufacturers are facing heightened scrutiny from regulatory agencies, particularly around nitrosamine impurities in finished products. This…

Potency OOS after equipment cleaning: containment CAPA and effectiveness checks

Addressing Potency OOS Following Equipment Cleaning: Steps for Effective Containment and CAPA Implementation Instances of out-of-specification (OOS) results related to potency after equipment cleaning represent a significant challenge for pharmaceutical…

Packaging Dry-Out after backing material change: GMP investigation plan and CAPA

GMP Investigation Plan and CAPA for Packaging Dry-Out Following Backing Material Change In the highly regulated environment of pharmaceutical manufacturing, any changes to product materials can lead to unexpected challenges.…

Finished product nitrosamine risk assessment gap after method transfer to a new QC lab: manufacturing vs lab root cause mapping and required evidence

Assessing Risks of Nitrosamine Gaps in Finished Products After QC Method Transfer In the pharmaceutical industry, ensuring the safety and efficacy of finished products is paramount. One of the crucial…

Stability failure during shared facility campaign: risk assessment for patient safety

“`html Assessing Stability Failures During a Shared Facility Campaign to Ensure Patient Safety In the context of pharmaceutical manufacturing, stability failures during a shared facility campaign can pose significant risks,…

Coating Weight Variability in transdermal patch manufacturing: inspection-ready documentation pack

Addressing Coating Weight Variability in the Manufacturing of Transdermal Patches: An Investigation Approach Coating weight variability during the manufacturing of transdermal patches can lead to significant deviations from product quality,…