Investigation – Page 50

Pump Actuation Failure during EU/UK launch supply: method variability vs true product failure assessment

Assessing the Impact of Pump Actuation Failure during EU/UK Launch Supply Pump actuation failures during the launch of inhalation products can lead to significant production delays and regulatory scrutiny. As…

Stability Failure during FDA inspection: CAPA plan with effectiveness checks

Addressing Stability Failures During FDA Inspections: A Comprehensive CAPA Strategy Stability failures can lead to significant compliance issues during FDA inspections, resulting in the need for extensive investigations and corrective…

Software Validation Gap after device supplier change: batch release impact and documentation pack

Addressing Software Validation Gaps Post Device Supplier Transition: Navigating Batch Release and Documentation Challenges In pharmaceutical manufacturing, changes in suppliers, especially for critical components such as software or combination devices,…

Finished product extractables & leachables signal during deviation triage meeting: data integrity review steps for LIMS/EMR/ES and chromatography systems

Extractables and Leachables Signals During Deviation Triage: Effective Data Integrity Review Steps In the realm of pharmaceutical manufacturing, the integrity of data regarding finished product extractables and leachables (E&L) signals…

Aseptic manipulation deviation during tech transfer: regulatory risk assessment and CAPA

Aseptic Manipulation Deviation During Technology Transfer: A Comprehensive Path to Investigation and CAPA The pharmaceutical industry faces continuous scrutiny along the drug development lifecycle, particularly during technology transfer phases, where…

Cascade Impactor Setup Error in nasal spray filling: how to trend dose delivery data in CPV

Cascade Impactor Setup Error in Nasal Spray Filling: Trending Dose Delivery Data in CPV In today’s dynamic pharmaceutical manufacturing landscape, the precision of dosage delivery is paramount, particularly in products…

Regulatory Classification Issue during PAI readiness: ownership between drug GMP and device QMS

Assessing Regulatory Classification Challenges for PAI Readiness: Coordination Between Drug GMP and Device QMS In the intricate landscape of pharmaceutical manufacturing, the convergence of drug GMP and device QMS presents…

Design Controls Deficiency during EMA/MHRA review: what inspectors expect and how to fix it

Addressing Design Controls Deficiencies during Regulatory Reviews: Insights and Solutions In the highly regulated pharmaceutical industry, compliance with design controls is essential during product development and manufacturing. A deficiency related…

Software Validation Gap during EMA/MHRA review: CAPA plan with effectiveness checks

Addressing Software Validation Gaps During EMA and MHRA Reviews: A Practical Investigation Guide In the highly regulated pharmaceutical industry, software validation is a critical component ensuring product quality, compliance, and…

Finished product impurity increase on stability after process parameter adjustment: risk assessment for patient impact and field alert / recall triggers

Assessing Impurity Increases in Finished Products Post Process Parameter Adjustments In pharmaceutical manufacturing, the integrity of finished products is paramount. An increase in impurities during stability studies following adjustments to…

Aseptic manipulation deviation during ATMP manufacturing: regulatory risk assessment and CAPA

Assessing Aseptic Manipulation Deviations in ATMP Manufacturing: A Methodical Approach Aseptic manipulation deviations during Advanced Therapy Medicinal Product (ATMP) manufacturing pose significant challenges to regulatory compliance and product integrity. These…

E&L Failure during inspection preparation: device qualification and assembly controls

Addressing E&L Failures during Device Qualification and Assembly Controls In the pharmaceutical industry, ensuring the safety and efficacy of inhalation and nasal dosage forms is critical, especially during inspection preparations.…