EMA – Page 171 – Pharma.Tips

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.…

Risk Management File Gap during lifecycle management: risk assessment and change control template

Addressing Risk Management File Gaps during Lifecycle Management in Pharmaceutical Manufacturing In the dynamic world of pharmaceutical manufacturing, ensuring robust risk management throughout the lifecycle of a product is paramount.…

Assembly Process Validation Failure during PAI readiness: risk assessment and change control template

Assessing Assembly Process Validation Failures in PAI Readiness: An Investigative Approach Within the pharmaceutical manufacturing landscape, assembly process validation failures can severely impede the readiness for a Pre-Approval Inspection (PAI).…

Finished product microbial limits failure after scale-up to commercial equipment: how to defend specification setting and outlier handling during inspection

Managing Microbial Limits Failures in Finished Products Post Scale-Up Microbial limits failures can present significant challenges in pharmaceutical manufacturing, especially when transitioning from laboratory to commercial-scale production. Such failures not…

Cryopreservation failure during tech transfer: regulatory risk assessment and CAPA

Cryopreservation Challenges During Tech Transfer: An Investigation Approach Cryopreservation is a critical process for preserving the integrity of biological materials during tech transfer in pharmaceutical manufacturing. The failure of this…

Cascade Impactor Setup Error at stability pull: device qualification and assembly controls

Investigating Cascade Impactor Setup Errors During Stability Pulls In the realm of pharmaceutical manufacturing, particularly within inhalation and nasal dosage forms, the setup and qualification of apparatus such as cascade…

Design Controls Deficiency during tech transfer: risk assessment and change control template

Investigating Design Controls Deficiencies in Tech Transfer: Risk Assessment and Change Control In the pharmaceutical manufacturing landscape, tech transfer represents a critical phase where a product moves from development to…

Stability Failure after device supplier change: what inspectors expect and how to fix it

Addressing Stability Failures Following a Change in Device Suppliers: Insights for Inspectors and Professionals Manufacturers in the pharmaceutical industry often face complex challenges when implementing changes in their production processes,…

Supplier Qualification Gap for combination drug products: risk assessment and change control template

Addressing Gaps in Supplier Qualification for Combination Drug Products In the complex arena of pharmaceutical manufacturing, ensuring the qualification of suppliers for combination drug products is vital. A gap in…

API starting material traceability gap during FDA inspection readiness: regulatory impact assessment and change control remediation plan

Evaluating and Addressing API Starting Material Traceability Gaps for FDA Inspection Readiness In the highly regulated pharmaceutical manufacturing environment, the ability to demonstrate robust traceability for active pharmaceutical ingredients (APIs)…