Investigation – Page 28

Particulate matter OOS in ophthalmic/otic manufacturing: CAPA and sterility assurance controls

Managing Out-of-Specification Results for Particulate Matter in Ophthalmic and Otic Manufacturing Particulate matter out-of-specification (OOS) results in ophthalmic and otic products present significant challenges for pharmaceutical manufacturers, directly impacting product…

Biosimilar process change without bridging study during commercial launch readiness: decision tree for lab method variability vs true product differences

Evaluating Process Changes for Biosimilars Without Bridging Studies Prior to Commercial Launch In the pharmaceutical manufacturing sector, ensuring the quality and consistency of biosimilars is paramount. When faced with a…

Supply interruption risk during small-batch manufacturing: FDA/EMA communication strategy

Understanding Supply Interruption Risks in Small-Batch Manufacturing: A Communication Strategy for FDA and EMA Compliance In the realm of pharmaceutical manufacturing, particularly in the niche of small-batch production, supply interruptions…

Sterility test failure during inspection readiness: CAPA and sterility assurance controls

Sterility Testing Failures: Effective CAPA and Controls for Inspection Readiness In pharmaceutical manufacturing, especially in the production of ophthalmic and otic products, a sterility test failure can pose significant challenges…

Biosimilar method transfer failure across labs during stability pull comparisons: FDA/EMA expectations for root cause, rework, and comparability justification

Understanding Root Causes of Biosimilar Method Transfer Failure Across Labs During Stability Pull Comparisons Biosimilars are crucial for expanding treatment options in pharmaceuticals, but method transfer failures across different labs…

Supply interruption risk during inspection readiness: risk-based GMP justification

“`html Mitigating Supply Interruption Risks During Inspection Readiness: A Practical Guide for Pharma Professionals In today’s highly regulated pharmaceutical environment, maintaining supply continuity is crucial, especially during FDA, EMA, or…

PET failure during stability pull: batch disposition and patient risk assessment

Evaluating PET Failure During Stability Pull: Batch Disposition and Patient Risk Assessment In the pharmaceutical manufacturing industry, maintaining product stability is critical for ensuring patient safety and compliance with regulatory…

Biosimilar comparability package deficiency during biosimilar development: risk assessment for critical quality attributes and clinical impact

Addressing Deficiencies in Biosimilar Comparability Packages During Development The increasing complexity of biosimilars has heightened the significance of comparability assessments. A deficiency in the comparability package during biosimilar development can…

Specification justification gap during regulatory review: FDA/EMA communication strategy

Addressing Specification Justification Gaps During Regulatory Review: A Comprehensive Investigation Approach In the pharmaceutical industry, gaps in specification justification can create significant roadblocks during regulatory reviews by bodies such as…

Sterility test failure in ophthalmic/otic manufacturing: CAPA and sterility assurance controls

Addressing Sterility Test Failures in Ophthalmic and Otic Manufacturing: A Comprehensive Investigation Sterility test failures pose significant challenges in the manufacturing of ophthalmic and otic products. Such failures can trigger…

Biosimilar aggregate level increase after cell line or upstream change: CAPA strategy to restore similarity and prevent regulatory delays

Biosimilar Aggregate Level Increase After Upstream Changes: Investigation and CAPA Strategies The pharmaceutical landscape is continually evolving, particularly with the emergence of biosimilars. A common challenge encountered is the increase…

Supply interruption risk during regulatory review: FDA/EMA communication strategy

Managing Supply Interruption Risks During Regulatory Review: A Practical Investigation Approach The pharmaceutical landscape is fraught with complexities that can impact product availability, particularly during regulatory reviews. When a supply…