EMA – Page 160 – Pharma.Tips

Finished product label mix-up deviation during PAI / FDA inspection readiness: manufacturing vs lab root cause mapping and required evidence

Addressing Finished Product Label Mix-Up Deviations During PAI: Manufacturing vs. Lab Root Cause Mapping Label mix-up deviations pose a significant challenge during pre-approval inspections (PAIs), especially amid rigorous scrutiny from…

Cross-contamination risk during stability pull: risk assessment for patient safety

Assessing Cross-contamination Risks During Stability Pulls: A Comprehensive Investigation Approach In the pharmaceutical manufacturing environment, ensuring the integrity of stability studies is crucial for patient safety and compliance with regulatory…

Assay Oos after adhesive change: inspection-ready documentation pack

Investigation of Assay OOS Following Adhesive Change in Pharmaceutical Manufacturing In the competitive landscape of pharmaceutical manufacturing, the quality and reliability of assay results are paramount. A recent scenario surfaced…

Finished product coating non-uniformity during CPV annual product review: how to build a deviation package that passes an inspection deep-dive

Addressing Finished Product Coating Non-Uniformity in CPV Annual Product Reviews In pharmaceutical manufacturing, the integrity and uniformity of product coatings are critical. Deviations observed during annual product reviews, particularly concerning…

Potency OOS during shared facility campaign: FDA/EMA investigation expectations

“`html Understanding and Investigating Potency Out-of-Specification Results during Shared Facility Campaigns Potency out-of-specification (OOS) results present significant challenges in the pharmaceutical manufacturing landscape, particularly during shared facility campaigns. These situations…

Edge Lifting at accelerated stability: root cause mapping across materials and process

Exploring Root Causes of Edge Lifting at Accelerated Stability Tests in Transdermal Products In the pharmaceutical manufacturing landscape, especially within the domain of transdermal drug delivery systems, edge lifting presents…

Finished product content uniformity OOS during complaint trending review: CAPA plan that inspectors accept (with effectiveness checks and due dates)

Managing OOS Results for Finished Product Content Uniformity: Effective CAPA Planning for Inspectors In the fast-paced world of pharmaceutical manufacturing, maintaining consistency in finished product content is crucial to ensure…

Assay drift during stability pull: containment CAPA and effectiveness checks

Managing Assay Drift during Stability Pull: A Comprehensive Investigation Guide Assay drift can pose a significant challenge during stability studies, particularly when testing oncology products. When assay results deviate from…

Ivpt Failure during EU/UK market supply: GMP investigation plan and CAPA

Investigation Plan and CAPA for Ivpt Failure in EU/UK Market Supply The pharmaceutical industry often faces challenges related to in vitro permeation testing (Ivpt) failures, especially when supplying products to…

Finished product dissolution failure during routine batch release: manufacturing vs lab root cause mapping and required evidence

Root Cause Mapping for Finished Product Dissolution Failures in Batch Release In the highly regulated landscape of pharmaceutical manufacturing, the failure of a finished product to meet dissolution specifications can…

Assay drift during shared facility campaign: risk assessment for patient safety

Assessing the Causes and Solutions for Assay Drift during a Shared Facility Campaign Assay drift in pharmaceutical manufacturing, particularly during shared facility campaigns, is a critical concern that can undermine…

Drug Crystallization in transdermal patch manufacturing: root cause mapping across materials and process

Investigating Drug Crystallization Issues in Transdermal Patch Manufacturing In the highly regulated world of pharmaceutical manufacturing, drug crystallization can pose a significant challenge during the production of transdermal patches. Variations…