Deviation – Page 160

Microbial Limits Failure during bulk hold: manufacturing vs lab root cause decision tree

Investigating Microbial Limits Failures During Bulk Hold: A Comprehensive Decision Tree Approach In the highly regulated world of pharmaceutical manufacturing, microbial limits failures during bulk hold can unravel a well-planned…

Particle Size Distribution Oos during EU/UK distribution qualification: packaging integrity and transport risk assessment

Analyzing the OOS Results of Particle Size Distribution During EU/UK Distribution Qualification In pharmaceutical manufacturing, particularly in aerosol formulations, maintaining the quality of products throughout distribution is critical. A common…

Leakage Failure during EU/UK distribution qualification: device qualification and crimp validation controls

Addressing Leakage Issues in Device Qualification During EU and UK Distribution Leakage failures during distribution qualification can pose serious risks to pharmaceutical manufacturers, especially when dealing with aerosol formulations. These…

Valve Malfunction during method transfer: method variability vs true product failure assessment

Assessing Valve Malfunctions during Method Transfer: Distinguishing Variability from Authentic Failure In pharmaceutical manufacturing, maintaining the integrity of the production process is paramount. An essential component of this process is…

API starting material traceability gap during stability pull at 6/12 months: how to write a defensible deviation narrative for inspections

Managing API Starting Material Traceability Gaps During Stability Pulls: Crafting a Defensible Investigation Narrative In the pharmaceutical manufacturing landscape, ensuring the traceability of Active Pharmaceutical Ingredients (APIs) is critical during…

Phase Separation after supplier change: sanitation, water, and EM checks

Investigation of Phase Separation Issues Following Supplier Change: Best Practices for Sanitation, Water, and Environmental Monitoring The pharmaceutical industry must ensure that all products meet stringent quality standards. A notable…

Canister Corrosion in MDI assembly: packaging integrity and transport risk assessment

Assessing Canister Corrosion in MDI Assembly: A Comprehensive Investigation Canister corrosion in Metered Dose Inhalers (MDIs) poses significant risks to product integrity and patient safety, resulting in out-of-specification (OOS) events…

Canister Corrosion after valve supplier change: device qualification and crimp validation controls

Addressing Canister Corrosion Following Valve Supplier Modification: Effective Device Qualification and Crimp Validation Controls In recent months, a significant increase in canister corrosion incidents has been observed in aerosol formulations…

API packaging moisture ingress issue after raw material supplier change: risk-based approach to prevent repeat OOS across future API batches

“`html Addressing Moisture Ingress Issues in API Packaging Following a Supplier Change In recent weeks, several manufacturing plants have reported out-of-specification (OOS) results related to moisture ingress in API packaging…

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