EMA – Page 155 – Pharma.Tips

Potency variability after cleaning cycle change: CAPA aligned to regulatory expectations

Addressing Potency Variability Triggered by Changes in Cleaning Cycles The pharmaceutical industry continually strives for optimal product consistency, especially concerning hormonal products that often require stringent potency and quality standards.…

Biologic leachables signal from single-use systems during PPQ / process validation: how to document root cause when multiple unit operations are involved

Addressing Biologic Leachables Signals from Single-Use Systems During Process Validation The emergence of biologic leachables signals during process performance qualification (PPQ) can pose significant challenges for pharmaceutical manufacturers. Understanding how…

Stability degradation during inspection readiness: GMP investigation and containment strategy

GMP Investigation and Containment Strategy for Stability Degradation During Inspection Readiness In the high-stakes environment of pharmaceutical manufacturing, stability degradation of products during inspection readiness presents significant risks. Such occurrences…

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…