Quality Systems – Page 222

Cryopreservation failure during ATMP manufacturing: inspection-ready investigation package

Investigation Package for Cryopreservation Failures in ATMP Manufacturing Cryopreservation is a critical process in the manufacturing of Advanced Therapy Medicinal Products (ATMPs), ensuring the viability of cellular and tissue-based therapies.…

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

Pump Actuation Failure in Nasal Spray Filling: Strategies for Trending Dose Delivery Data in Continuous Process Verification Pump actuation failure during nasal spray filling can lead to significant quality issues,…

Dhf Missing during FDA inspection: batch release impact and documentation pack

Impact of Missing DHF during FDA Inspections on Batch Release Documentation In the highly regulated environment of pharmaceutical manufacturing, adherence to Good Manufacturing Practices (GMP) is crucial. One recurring issue…

Oos Investigation during tech transfer: ownership between drug GMP and device QMS

Managing OOS Investigations During Tech Transfer: Bridging Drug GMP and Device QMS In the intricate world of pharmaceutical manufacturing and device integration, deviations and out-of-specification (OOS) results can pose significant…

API stability failure at accelerated conditions during FDA inspection readiness: supplier qualification gaps and incoming testing upgrades to close the loop

Addressing API Stability Failures during FDA Inspection Readiness with Supplier Qualification and Testing Enhancements In the pharmaceutical manufacturing landscape, ensuring the stability of Active Pharmaceutical Ingredients (APIs) is critical for…

Vector potency drift during ATMP manufacturing: inspection-ready investigation package

Investigating Vector Potency Drift in ATMP Manufacturing: A Practical Guide Vector potency drift during Advanced Therapy Medicinal Product (ATMP) manufacturing poses significant risks to product consistency, safety, and regulatory compliance.…

Apsd Oos in DPI manufacturing: device qualification and assembly controls

Addressing Apsd Oos in DPI Manufacturing: Device Qualification and Assembly Controls In the domain of pharmaceutical manufacturing, especially in the production of dry powder inhalers (DPIs), Out of Specification (OOS)…

Gmp Gap for drug-device combination products: risk assessment and change control template

Identifying and Addressing GMP Gaps in Drug-Device Combination Products In the realm of pharmaceutical manufacturing, specifically concerning drug-device combination products, the compliance with Good Manufacturing Practices (GMP) is crucial. However,…

E&L Failure for drug-device combination products: what inspectors expect and how to fix it

Addressing E&L Failures in Drug-Device Combination Products: Inspection Expectations and Remedial Actions As the complexities of drug-device combination products evolve, so too do the challenges associated with extractables and leachables…

Complaint Handling Deficiency during PAI readiness: what inspectors expect and how to fix it

Addressing Complaint Handling Deficits During PAI Readiness: Inspector Expectations and Effective Solutions In the ever-evolving landscape of pharmaceutical manufacturing, preparing for a Pre-Approval Inspection (PAI) brings public health scrutiny to…

API endotoxin risk in sterile API after drying cycle optimization: how to justify reprocessing vs rejection to FDA/EMA inspectors

Managing API Endotoxin Risks in Sterile API During Drying Cycle Optimization In the pharmaceutical industry, ensuring that active pharmaceutical ingredients (APIs) are free from contamination is paramount. The presence of…

Chain of identity breach during scale-up: regulatory risk assessment and CAPA

Assessing Chain of Identity Breaches During Scale-Up: A Practical Investigation Approach In pharmaceutical manufacturing, particularly with advanced therapy medicinal products (ATMPs), a breach in the chain of identity during scale-up…