pharma QA – Page 76 – Pharma.Tips

API heavy metals / elemental impurities OOS during FDA inspection readiness: risk-based approach to prevent repeat OOS across future API batches

Managing OOS for Heavy Metals in API: A Risk-Based Investigation Framework As pharmaceutical manufacturers navigate the complexities of regulatory compliance, one critical aspect has come to the forefront: the Out…

Pet Failure in otic suspension filling: packaging integrity and stability justification

Investigating Pet Failures in Otic Suspension Filling: Ensuring Packaging Integrity and Stability In the pharmaceutical manufacturing sector, particularly within otic dosage forms, maintaining the integrity and stability of products during…

Crimp Diameter Variability in MDI assembly: FDA/MHRA inspection-ready documentation

Addressing Crimp Diameter Variability in MDI Assembly: Your Guide to Effective Investigation Crimp diameter variability in Metered Dose Inhaler (MDI) assembly can lead to serious compliance issues and quality concerns…

Drop Test Failure after valve supplier change: FDA/MHRA inspection-ready documentation

Managing Drop Test Failures Following a Valve Supplier Change In the dynamic world of pharmaceutical manufacturing, change is a constant theme. However, changes such as a supplier switch, especially for…

API microbial limit failure during routine release testing: root cause analysis (process vs lab) with CAPA effectiveness checks

Root Cause Analysis of Microbial Limit Failures in API Release Testing In pharmaceutical manufacturing, the detection of microbial limit failures during routine release testing of active pharmaceutical ingredients (APIs) can…

Leakage Complaint during method transfer: investigation steps with CAPA evidence

Investigating Leakage Complaints during Method Transfer: Key Steps and CAPA Evidence In the landscape of pharmaceutical manufacturing, complaints regarding leakage during method transfer can present significant operational challenges. Such leakage…

Propellant–Formulation Incompatibility after valve supplier change: device qualification and crimp validation controls

Addressing Propellant–Formulation Incompatibility After Valve Supplier Change: A Focused Investigation Approach The pharmaceutical industry is witnessing increased complexity in formulation requirements and device compatibility. A significant issue arises when there…

Delivered Dose Oos in aerosol filling: method variability vs true product failure assessment

Delivered Dose OOS in Aerosol Filling: Evaluating Method Variability vs. True Product Failure The occurrence of Out of Specification (OOS) results in aerosol filling processes presents significant challenges for pharmaceutical…

Spray Pattern Failure during EU/UK distribution qualification: packaging integrity and transport risk assessment

Addressing Spray Pattern Failures in the EU/UK Distribution Qualification of Aerosols In pharmaceutical manufacturing, ensuring the integrity of aerosol products during distribution qualifications is crucial. A recent incident involving a…

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…