EMA – Page 151 – Pharma.Tips

CCIT failure during stability pull: CAPA and sterility assurance controls

CAPA and Sterility Assurance Controls Following CCIT Failures in Stability Pulls In the pharmaceutical manufacturing sector, ensuring the integrity and sterility of products is of paramount importance. A recent instance…

Biologic comparability failure after process change during FDA/EMA inspection readiness: CAPA package with CQA/CPP risk assessment and effectiveness verification

Investigation of Biologic Comparability Failures Post-Process Change for Inspection Readiness Pharmaceutical manufacturers face significant challenges when conducting biologic comparability assessments, especially after process modifications. Biologic comparability failure can manifest in…

Method variability OOS during inspection readiness: risk-based GMP justification

Addressing Method Variability Leading to OOS During Inspection Readiness in Pharma During the quality control phase of pharmaceutical manufacturing, method variability can lead to Out of Specification (OOS) results, particularly…

Biologic filter integrity failure during CPV trending review: single-use systems risk controls, leachables review, and supplier oversight actions

Understanding and Investigating Biologic Filter Integrity Failures in CPV Trending Reviews In the landscape of pharmaceutical manufacturing, maintaining the integrity of biologic filters is vital for ensuring product quality and…

Supply interruption risk during small-batch manufacturing: CAPA with limited data sets

“`html Investigation of Supply Interruption Risks in Small-Batch Manufacturing In the realm of pharmaceutical manufacturing, particularly within small-batch environments, the integrity of supply chains is paramount. Suppose a facility identifies…

Biologic host cell protein (HCP) OOS after upstream media/raw material change: patient safety impact assessment and batch disposition governance

Managing Out-of-Specification (OOS) Host Cell Proteins (HCP) after Changes in Upstream Media and Raw Materials In the world of pharmaceutical manufacturing, quality assurance is paramount, particularly regarding biologic products. An…

Specification justification gap during inspection readiness: risk-based GMP justification

Identifying and Addressing Specification Justification Gaps During Inspection Readiness In the realm of pharmaceutical manufacturing, ensuring compliance with Good Manufacturing Practices (GMP) is critical, especially during inspection readiness scenarios where…

Biologic bioburden excursion pre-sterile filtration after filling line intervention: CAPA package with CQA/CPP risk assessment and effectiveness verification

Addressing Biologic Bioburden Excursion Pre-Sterile Filtration Following a Filling Line Intervention In the realm of pharmaceutical manufacturing, biologic products are susceptible to bioburden excursions that can lead to increased risks…

Stability failure with limited batches during regulatory review: CAPA with limited data sets

Addressing Stability Failures in Limited Batches during Regulatory Reviews When stability failures occur in limited batches under regulatory scrutiny, it can present significant challenges for pharmaceutical manufacturers. The implications not…

Biologic upstream yield drop (OOT) during FDA/EMA inspection readiness: viral safety and contamination response plan with inspection-ready evidence

Addressing the Drop in Biologic Upstream Yields During FDA/EMA Readiness: A Comprehensive Investigation In the highly regulated field of pharmaceutical manufacturing, especially in the production of biologics, encountering a drop…

Method variability OOS during regulatory review: CAPA with limited data sets

Investigation of Method Variability OOS During Regulatory Review: Effective CAPA with Limited Data Sets In pharmaceutical manufacturing, method variability leading to Out of Specification (OOS) results can occur even during…

Biologic upstream yield drop (OOT) during commercial manufacturing campaign: CAPA package with CQA/CPP risk assessment and effectiveness verification

Addressing the Root Causes of Biologic Upstream Yield Drop during Commercial Manufacturing Campaigns In the highly regulated field of pharmaceutical manufacturing, particularly in the production of biologics, maintaining optimal yield…