FDA – Page 280 – Pharma.Tips

API starting material traceability gap during EU GMP inspection preparation: how to justify reprocessing vs rejection to FDA/EMA inspectors

Addressing Gaps in API Starting Material Traceability for EU GMP Inspections In the realm of pharmaceutical manufacturing, ensuring traceability of active pharmaceutical ingredients (APIs) is crucial for regulatory compliance, particularly…

Leakage Complaint during bulk hold: sanitation, water, and EM checks

Investigating Bulk Hold Leakage Complaints in Pharmaceutical Manufacturing In pharmaceutical manufacturing, particularly in the production of otic dosage forms, a leakage complaint during bulk hold can lead to serious compliance…

Valve Malfunction at stability pull: method variability vs true product failure assessment

Assessing Valve Malfunction at Stability Pull: Evaluating Method Variability versus Genuine Product Failure In the realm of pharmaceutical manufacturing, the integrity and reliability of dosage formulation equipment are paramount. One…

Net Content Failure in aerosol filling: FDA/MHRA inspection-ready documentation

How to Investigate Net Content Failure in Aerosol Filling for FDA and MHRA Compliance Net content failures in aerosol filling can pose significant issues in pharmaceutical manufacturing, leading to regulatory…

API container closure compatibility failure during CPV trending review: supplier qualification gaps and incoming testing upgrades to close the loop

Understanding API Container Closure Compatibility Failures During CPV Trending Reviews In pharmaceutical manufacturing, deviations and out-of-specification (OOS) results can arise from various factors, one of which is the compatibility of…

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…