Investigation – Page 51

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)…

Vector potency drift during stability testing: regulatory risk assessment and CAPA

Analyzing Vector Potency Drift During Stability Testing: A Comprehensive Investigation Guide Vector potency drift during stability testing can present significant challenges for pharmaceutical manufacturers, particularly those involved in the development…

Delivered Dose Uniformity Failure after device supplier change: method variability vs true product failure assessment

Assessing Delivered Dose Uniformity Failures Following a Change in Device Suppliers: Identifying Variability Versus Actual Product Failures In the pharmaceutical industry, the integrity and reliability of dosage forms are critical…

Supplier Qualification Gap during EMA/MHRA review: ownership between drug GMP and device QMS

Understanding Supplier Qualification Gaps in EMA and MHRA Reviews: A Comprehensive Investigation In the complex landscape of pharmaceutical manufacturing, ensuring compliance across various regulatory bodies such as EMA and MHRA…