Quality Systems – Page 236

API batch-to-batch variability trend (OOT) after equipment maintenance intervention: regulatory impact assessment and change control remediation plan

Assessing API Batch-to-Batch Variability Trends After Equipment Maintenance: A Comprehensive Investigation In pharmaceutical manufacturing, maintaining consistent quality across batches of Active Pharmaceutical Ingredients (APIs) is crucial. Variability in product characteristics,…

Cryopreservation failure during tech transfer: patient safety impact and disposition

Cryopreservation Challenges During Technology Transfer: Understanding Patient Safety Risks and Proper Disposition Procedures Cryopreservation is a pivotal method in the manufacturing of Advanced Therapy Medicinal Products (ATMPs), ensuring the viability…

Fine Particle Fraction Drift in DPI manufacturing: how to trend dose delivery data in CPV

Addressing Fine Particle Fraction Drift in DPI Manufacturing: Effective Trending and Investigation Strategies The pharmaceutical industry often faces challenges in maintaining product quality and compliance, particularly in the manufacturing of…

E&L Failure for drug-device combination products: CAPA plan with effectiveness checks

Addressing E&L Failures in Drug-Device Combination Products: A Practical Investigation Guide In the pharmaceutical landscape, the interplay between drug formulations and their delivery mechanisms, particularly in drug-device combination products, poses…

Complaint Handling Deficiency after device supplier change: risk assessment and change control template

Investigation of Complaint Handling Deficiency Following Device Supplier Change In the pharmaceutical manufacturing landscape, a change in device supplier can introduce various challenges, particularly in terms of compliance and quality…

API co-crystal / salt form inconsistency during CPV trending review: supplier qualification gaps and incoming testing upgrades to close the loop

“`html Addressing Inconsistencies in API Co-Crystal and Salt Forms During CPV Trending Reviews Manufacturers often encounter discrepancies in the co-crystal or salt forms of Active Pharmaceutical Ingredients (APIs) during Continued…

Cryopreservation failure during FDA inspection readiness: regulatory risk assessment and CAPA

Cryopreservation Failure Risk Assessment During FDA Inspection Preparation Cryopreservation is critical in the pharmaceutical industry, particularly for Advanced Therapy Medicinal Products (ATMPs). However, failures in this process may pose significant…

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

Investigating Cleaning Validation Gaps during Method Transfers In the dynamic landscape of pharmaceutical manufacturing, maintaining rigorous cleaning validation is crucial for ensuring product quality and patient safety. However, gaps in…

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

Addressing Missing DHF in Drug-Device Combination Products: A Comprehensive Investigation Guide In the dynamic landscape of pharmaceutical manufacturing, the integration of drug-device combination products presents unique challenges. One critical issue…

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

Investigating the Missing DHF Post Device Supplier Change: Ensuring Compliance Between Drug GMP and Device QMS The change of a device supplier presents unique challenges in pharmaceutical manufacturing, particularly when…

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

Addressing Supplier Qualification Gaps during Tech Transfer: Impacts on Batch Release and Documentation In pharmaceutical manufacturing, the transfer of technology between suppliers can often lead to issues impacting batch release…

API residual palladium OOS during tech transfer to a new site: how to justify reprocessing vs rejection to FDA/EMA inspectors

Managing Out of Specification Residual Palladium Levels During API Tech Transfer to a New Site In the realm of pharmaceutical manufacturing, particularly during the tech transfer of active pharmaceutical ingredients…