Deviation – Page 138

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…

Software Validation Gap for drug-device combination products: batch release impact and documentation pack

Addressing Software Validation Gaps in Drug-Device Combination Products: Implications for Batch Release and Documentation In the world of pharmaceutical manufacturing, ensuring the quality and compliance of drug-device combination products is…

API assay drift after raw material supplier change: data integrity and chromatographic audit trail review steps

Investigation Steps for API Assay Drift Following a Raw Material Supplier Change In the pharmaceutical manufacturing landscape, changes in raw material suppliers can provoke unexpected deviations, notably API assay drift.…

Chain of identity breach during stability testing: patient safety impact and disposition

Managing a Chain of Identity Breach During Stability Testing: Implications and Actionable Steps In the pharmaceutical manufacturing landscape, ensuring the integrity of product identity during stability testing is critical to…

Spray Pattern Failure during inspection preparation: method variability vs true product failure assessment

Understanding Spray Pattern Failures: A Comprehensive Investigation Approach In pharmaceutical manufacturing, ensuring the consistency and reliability of dosage forms is critical. One such challenge arises during the production of inhalation…

Design Controls Deficiency during EMA/MHRA review: ownership between drug GMP and device QMS

Understanding Design Controls Deficiency during EMA/MHRA Review: Bridging Drug GMP and Device QMS Design controls deficiencies during EMA or MHRA reviews can lead to significant setbacks in the pharmaceutical product…

Assembly Process Validation Failure during lifecycle management: batch release impact and documentation pack

Addressing Assembly Process Validation Failures Throughout Lifecycle Management: Understanding Batch Release Impacts and Documentation Requirements Pharmaceutical manufacturing is an intricate process where adherence to Good Manufacturing Practices (GMP) is paramount.…

Assembly Process Validation Failure for combination drug products: risk assessment and change control template

Understanding Assembly Process Validation Failures for Combination Drug Products: A Comprehensive Investigation Guide In the highly regulated environment of pharmaceutical manufacturing, validation failures can occur during various stages of the…

API heavy metals / elemental impurities OOS after cleaning validation requalification: root cause analysis (process vs lab) with CAPA effectiveness checks

Root Cause Analysis for Out-of-Specification Heavy Metals in API Post Cleaning Validation In the world of pharmaceutical manufacturing, ensuring the integrity of Active Pharmaceutical Ingredients (APIs) is paramount. One common…