Investigation – Page 35

Biologic hold-time failure for bulk drug substance during tech transfer to a CMO: single-use systems risk controls, leachables review, and supplier oversight actions

Addressing Biologic Hold-Time Failures for Bulk Drug Substance in CMO Tech Transfers Biologic hold-time failures during the tech transfer process to a Contract Manufacturing Organization (CMO) can raise significant challenges…

Stability degradation during multi-product campaign: CAPA aligned to regulatory expectations

Addressing Stability Degradation in Multi-Product Campaigns: A Comprehensive Investigation and CAPA Framework In the fast-paced and highly regulated world of pharmaceutical manufacturing, maintaining product integrity throughout multi-product campaigns is critical.…

Biologic sterility assurance gap after equipment qualification update: how to document root cause when multiple unit operations are involved

Addressing Biologic Sterility Assurance Gaps Post-Equipment Qualification Updates Encountering a sterility assurance gap in biologics following an equipment qualification update poses significant regulatory and operational challenges. This scenario, if mishandled,…

Cleaning validation failure after cleaning cycle change: GMP investigation and containment strategy

Understanding and Investigating Cleaning Validation Failures After Modifications to Cleaning Cycles In the highly regulated pharmaceutical manufacturing sector, cleaning validation is a critical component to ensure the integrity and quality…

Biologic bioburden excursion pre-sterile filtration after single-use system supplier change: investigation strategy aligned to FDA/EMA expectations and comparability principles

“`html Investigation Strategies for Bioburden Excursion Pre-Sterile Filtration Following a Single-Use System Supplier Change In pharmaceutical manufacturing, particularly in the production of biologics, excursions in bioburden levels prior to sterile…

Potency variability after cleaning cycle change: GMP investigation and containment strategy

“`html GMP Investigation of Potency Variability Following a Cleaning Cycle Change Potency variability is a critical concern in pharmaceutical manufacturing, particularly after a change in cleaning cycles. This situation demands…

Biologic container closure integrity failure during downstream purification scale-up: how to justify rework/reprocessing vs rejection for biologic lots

“`html Understanding Biologic Container Closure Integrity Failures During Downstream Purification Scale-Up In the realm of biologics, ensuring the integrity of container closures during downstream purification processes is fundamental. A failure…

Stability degradation after cleaning cycle change: GMP investigation and containment strategy

Addressing Stability Degradation After Altering Cleaning Cycles: A GMP Investigation and Containment Strategy In the pharmaceutical manufacturing sector, maintaining product stability is paramount, particularly after making changes to cleaning processes.…

Biologic cell culture contamination event during deviation investigation board review: how to justify rework/reprocessing vs rejection for biologic lots

Investigation of Biologic Cell Culture Contamination Events: Evaluating Rework vs Rejection Cell culture contamination events can significantly impact the production and quality of biologics, leading to costly deviations and potential…

Blend uniformity OOS after cleaning cycle change: CAPA aligned to regulatory expectations

Investigation of Blend Uniformity OOS Following a Cleaning Cycle Change In pharmaceutical manufacturing, maintaining an effective cleaning cycle is integral to ensuring product quality and compliance with Good Manufacturing Practices…

Biologic stability failure (real-time/accelerated) during commercial manufacturing campaign: investigation strategy aligned to FDA/EMA expectations and comparability principles

Investigating Biologic Stability Failures during Commercial Manufacturing Campaigns In the realm of pharmaceutical manufacturing, the stability of biologics is a critical component, especially during commercial campaigns. Unforeseen stability failures, whether…

Cleaning validation failure during CPV review: facility and HVAC risk mitigation

Mitigating Risks Following a Cleaning Validation Failure During CPV Review Cleaning validation failures can pose significant risks in pharmaceutical manufacturing, particularly during Continued Process Verification (CPV) reviews. This article demonstrates…