EMA – Page 157 – Pharma.Tips

Biologic subvisible particles OOS during stability pull at 3/6/12 months: investigation strategy aligned to FDA/EMA expectations and comparability principles

“`html Investigation Strategy for OOS of Biologic Subvisible Particles During Stability Pulls: Aligning with FDA/EMA Expectations Encountering out-of-specification (OOS) results for subvisible particles during stability pulls at 3, 6, and…

Cleaning validation failure after cleaning cycle change: facility and HVAC risk mitigation

Investigating Cleaning Validation Failures Following Changes in Cleaning Cycles: Mitigation Strategies for Facilities and HVAC Systems Cleaning validation failures can present significant challenges in pharmaceutical manufacturing, particularly following changes to…

Finished product hardness / friability drift during routine batch release: how to defend specification setting and outlier handling during inspection

Addressing Variations in Finished Product Hardness and Friability During Routine Batch Releases In pharmaceutical manufacturing, ensuring that finished products meet the predefined specifications is a critical component of quality control.…

Blend uniformity OOS during multi-product campaign: CAPA aligned to regulatory expectations

Addressing Out-of-Specification Blend Uniformity During Multi-Product Campaigns Out-of-Specification (OOS) incidents related to blend uniformity during multi-product campaigns can pose significant challenges in pharmaceutical manufacturing. Specifically, these events can jeopardize product…

Finished product stability trend (OOT) during stability pull at accelerated conditions: stability strategy adjustments and packaging risk mitigation steps

Addressing Out-of-Trend Stability Results During Accelerated Testing: A Systematic Investigation Approach In the fast-paced world of pharmaceutical manufacturing, a finished product stability trend identified as out-of-trend (OOT) can raise significant…

Occupational exposure limit breach during inspection prep: FDA/EMA investigation expectations

Understanding the Breach of Occupational Exposure Limits During Inspection Preparation In the realm of pharmaceutical manufacturing, particularly when preparing for regulatory inspections, the integrity of operational practices is crucial. One…

Finished product coating non-uniformity during PAI / FDA inspection readiness: how to build a deviation package that passes an inspection deep-dive

Addressing Non-Uniformity in Finished Product Coating for FDA Inspection Readiness Finished product coating non-uniformity is a pressing issue during Pre-Approval Inspections (PAI) that can lead to deviations, out-of-specification (OOS) results,…

Assay drift after equipment cleaning: containment CAPA and effectiveness checks

Investigation Strategies for Assay Drift Post-Equipment Cleaning in Pharmaceutical Manufacturing Assay drift in the context of pharmaceutical manufacturing can have significant implications, particularly when linked to equipment cleaning processes. This…

Finished product hardness / friability drift during complaint trending review: how to defend specification setting and outlier handling during inspection

Understanding Hardness and Friability Drift in Finished Products: A Comprehensive Approach for Investigation and Compliance In the pharmaceutical manufacturing landscape, maintaining specification parameters for finished products, such as hardness and…

Potency OOS in oncology manufacturing: FDA/EMA investigation expectations

Understanding Potency OOS in Oncology Manufacturing: Investigation and Compliance Strategy Deviations related to out-of-specification (OOS) potency results in oncology manufacturing can lead to significant regulatory scrutiny and product quality concerns.…

Finished product impurity increase on stability during stability pull at accelerated conditions: CAPA plan that inspectors accept (with effectiveness checks and due dates)

Dealing with Increased Impurities During Stability Pulls: An Investigative Approach for Pharma Professionals In the fast-paced world of pharmaceutical manufacturing, maintaining the integrity and quality of finished products is paramount.…

Assay drift during inspection prep: FDA/EMA investigation expectations

Understanding Assay Drift During Inspection Preparation: Navigating FDA/EMA Investigation Requirements Assay drift during the preparation for inspections can present significant compliance challenges within pharmaceutical manufacturing. As a quality or manufacturing…