EMA – Page 164 – Pharma.Tips

Finished product packaging leakage complaint after method transfer to a new QC lab: FDA-compliant investigation flow and batch disposition decision tree

Investigating Packaging Leakage Complaints Following Method Transfer to a New QC Lab Packaging leakage in finished pharmaceutical products (FPPs) represents a critical quality issue, especially when linked to a recent…

Stability failure during stability pull: containment CAPA and effectiveness checks

“`html Addressing Stability Failures During Stability Pull: Containment CAPA and Effectiveness Checks In the pharmaceutical manufacturing realm, stability failures during stability pull are a critical concern, particularly within oncology product…

Apsd Oos in DPI manufacturing: E&L risk assessment and documentation

Addressing Apsd OOS in DPI Manufacturing Through Effective Documentation and Risk Assessment The pharmaceutical manufacturing industry increasingly faces challenges associated with Out of Specification (OOS) results, particularly in the production…

Finished product hardness / friability drift during EMA/MHRA inspection preparation: CAPA plan that inspectors accept (with effectiveness checks and due dates)

Addressing Variations in Finished Product Hardness and Friability During Inspection Preparations In the pharmaceutical manufacturing sector, maintaining the quality attributes of finished products is crucial. A common concern is the…

Potency OOS after equipment cleaning: risk assessment for patient safety

Investigation of Potency OOS Events Following Equipment Cleaning In the intricate domain of pharmaceutical manufacturing, particularly when dealing with oncology products, the occurrence of Out of Specification (OOS) results post-equipment…

Leakage Complaint during inspection preparation: FDA/MHRA investigation and corrective actions

Addressing Leakage Complaints during Inspection Preparation: FDA and MHRA Best Practices In the pharmaceutical manufacturing environment, leakage complaints during inspection preparation can signal significant quality issues. These complaints can stem…

Finished product out-of-spec pH during complaint trending review: how to build a deviation package that passes an inspection deep-dive

Addressing Out-of-Spec pH in Finished Pharmaceutical Products: A Comprehensive Investigation Guide During routine quality control, an out-of-specification (OOS) result for pH can signal underlying issues in manufacturing or product formulation.…

Assay drift during stability pull: risk assessment for patient safety

“`html Understanding Assay Drift During Stability Pull: A Comprehensive Investigation for Risk Assessment Assay drift during stability pulls can lead to significant concerns in pharmaceutical manufacturing, especially within oncology products.…

Pump Actuation Failure at stability pull: FDA/MHRA investigation and corrective actions

Pump Actuation Issues During Stability Testing: Comprehensive Investigation and Corrective Actions In the realm of pharmaceutical manufacturing, ensuring consistent performance of delivery devices is critical. A recent incident involving pump…

Finished product transport excursion stability impact during PAI / FDA inspection readiness: how to build a deviation package that passes an inspection deep-dive

Addressing Transport Excursion Stability Impact on Finished Products for PAI/FDA Compliance In pharmaceutical manufacturing, ensuring the stability of finished products during transport is crucial for compliance with Good Manufacturing Practices…

Cross-contamination risk after equipment cleaning: containment CAPA and effectiveness checks

Managing Cross-Contamination Risks After Equipment Cleaning: A Comprehensive Investigation Approach Cross-contamination risk after equipment cleaning can lead to severe compliance issues and product safety hazards in pharmaceutical manufacturing. This article…

Apsd Oos during EU/UK launch supply: device qualification and assembly controls

Addressing Apsd Oos Issues during EU and UK Launch Supply: Ensuring Proper Device Qualification and Assembly Controls In the competitive landscape of pharmaceutical manufacturing, the launch of inhalation and nasal…