API quality – Page 6

Unjustified excipient choice during scale-up – risk assessment for excipient choice

Assessing Risks Related to Improper Excipients Selection during Scale-Up In pharmaceutical manufacturing, the choice of excipients during the scale-up phase can pose significant risks to product quality and regulatory compliance.…

Moisture sensitivity overlooked during stability assessment – risk assessment for excipient choice

Overlooking Moisture Sensitivity in Stability Assessments: A Risk Analysis for Excipient Selection Pharmaceutical professionals must safeguard product quality through effective excipient selection processes. One critical oversight that can undermine this…

Polymorphic form inconsistency during supplier change – regulatory impact assessment

Assessment of Regulatory Impact due to Polymorphic Form Inconsistency During Supplier Transition In the world of pharmaceutical manufacturing, maintaining the quality and consistency of active pharmaceutical ingredients (APIs) and excipients…

Impurity profile drift detected during deviation investigation – CAPA aligned to GMP expectations

Investigating Impurity Profile Drift in Pharmaceutical Manufacturing: A Structured Approach In today’s highly regulated pharmaceutical environment, deviations in impurity profiles of active pharmaceutical ingredients (APIs) often challenge compliance with Good…

Pharmacopoeial change not implemented during inspection – regulatory enforcement risk

Impact of Non-Implementation of Pharmacopoeial Changes Observed During Inspections The failure to implement pharmacopoeial changes is a critical concern for pharmaceutical manufacturers. Such lapses can lead to non-compliance during regulatory…

Specification not harmonized during supplier qualification – inspection-ready justification strategy

Justifying Inspection Readiness When Supplier Specifications are Not Harmonized In the intricate landscape of pharmaceutical manufacturing, ensuring that supplier specifications harmonize with established guidelines is pivotal for maintaining product quality…

Specification not harmonized during supplier qualification – regulatory enforcement risk

Managing Risks When Specifications Are Not Harmonized During Supplier Qualification Within the pharmaceutical industry, maintaining compliance with established specifications for active pharmaceutical ingredients (APIs) and excipients is critical. Instances of…

Pharmacopoeial change not implemented during routine testing – CAPA for compendial failures

CAPA for Compendial Failures: Addressing Unimplemented Pharmacopoeial Changes in Routine Testing The pharmaceutical industry operates under stringent regulatory requirements, emphasizing the importance of adhering to the latest pharmacopoeial standards. However,…

Unjustified in-house specification during submission support – preventing repeat observations

Preventing Repeat Observations Related to Unjustified In-house Specifications during Submission Support The recent trend of raising concerns around unjustified in-house specifications during submission support has underscored the need for robust…

Specification not harmonized during inspection – CAPA for compendial failures

Addressing Non-Harmonized Specifications During Inspection: A Comprehensive Investigation Approach In the pharmaceutical industry, ensuring that materials meet established specifications is critical for maintaining product quality and compliance. Instances of non-harmonized…

Specification not harmonized during supplier qualification – CAPA for compendial failures

Addressing Specification Non-Harmonization During Supplier Qualification: An Investigation Framework In the highly regulated pharmaceutical industry, ensuring the quality and consistency of raw materials and excipients is paramount. A common issue…

Test method non-compliance during submission support – regulatory enforcement risk

Investigating Test Method Non-Compliance During Submission Support to Mitigate Regulatory Risks The pharmaceutical industry operates under stringent regulatory scrutiny, ensuring compliance with guidelines to guarantee product quality, safety, and efficacy.…