Dosage Forms & Drug Delivery Systems – Page 50

Pump Actuation Failure in nasal spray filling: how to trend dose delivery data in CPV

The detection of pump actuation failure can manifest in various ways on the production floor or within laboratory assessments. Understanding these symptoms is crucial for initiating an effective investigation. The…

Software Validation Gap for drug-device combination products: ownership between drug GMP and device QMS

Identifying symptoms or signals associated with software validation gaps is an essential first step in any investigation. Symptoms can manifest in various forms, often detected through regular operations or unexpected…

Risk Management File Gap during lifecycle management: batch release impact and documentation pack

The first step in managing an RMF gap is recognizing the symptoms or signals that may indicate its presence. These may manifest in various ways: discrepancies in documentation, increased rates…

Complaint Handling Deficiency during FDA inspection: CAPA plan with effectiveness checks

Identifying symptoms or signals that indicate a potential complaint handling deficiency is critical. Symptoms can arise from various sources, including operational processes, laboratory results, and employee feedback. Below are common…

E&L Failure during method transfer: device qualification and assembly controls

Addressing E&L Failures During Method Transfer in Device Qualification and Assembly Control Equipment and Leachables (E&L) failures during method transfers in pharmaceutical manufacturing can have far-reaching consequences, particularly for inhalation…

Stability Failure for combination drug products: ownership between drug GMP and device QMS

Stability failures may yield various signals during production or testing phases. Recognizing these symptoms early is crucial to limiting their impact. Common indicators include:Click to read the full article.

Complaint Handling Deficiency during FDA inspection: batch release impact and documentation pack

The first step in identifying a complaint handling deficiency is recognizing symptoms or signals that indicate a potential issue. These may manifest in various forms:Click to read the full article.

E&L Failure in DPI manufacturing: device qualification and assembly controls

Detecting E&L failures early is crucial for maintaining product quality and regulatory compliance. Symptoms of E&L issues can appear during various stages of DPI manufacturing. Symptoms include:Click to read the…

Supplier Qualification Gap during tech transfer: batch release impact and documentation pack

Identifying symptoms of a supplier qualification gap during tech transfer is the first step toward effective resolution. Common signals include:Click to read the full article.

Dhf Missing after device supplier change: ownership between drug GMP and device QMS

When a DHF is missing following a change in device supplier, symptoms may manifest in multiple areas, often affecting quality control, manufacturing processes, and regulatory compliance. Key signals to monitor…

Dhf Missing for drug-device combination products: risk assessment and change control template

The initial identification of missing DHF components can surface through various signals, including:Click to read the full article.

Cleaning Validation Gap during method transfer: device qualification and assembly controls

Identifying signals of a cleaning validation gap is the initial step in managing compliance issues. Be vigilant for the following symptoms:Click to read the full article.