raw materials – Page 31

Outdated pharmacopoeial monograph used during inspection – CAPA for compendial failures

Investigating the Use of an Outdated Pharmacopoeial Monograph During Inspection Instances of using outdated pharmacopoeial monographs during inspections can substantially undermine regulatory compliance and product quality. This article aims to…

Unjustified in-house specification during supplier qualification – regulatory enforcement risk

Risks of Implementing Unjustified In-House Specifications During Supplier Qualification Pharmaceutical manufacturing relies heavily on the quality of raw materials and their compliance with established standards. An increasing trend is observed…

Specification not harmonized during submission support – inspection-ready justification strategy

Investigation into Non-Harmonized Specifications During Submission Support The pharmaceutical industry faces continuous challenges in ensuring compliance with regulatory expectations, especially when specifications are not harmonized during submission support. Such deviations…

Moisture sensitivity overlooked during formulation development – regulatory scrutiny of excipient data

Overlooking Moisture Sensitivity in Formulation Development: A Deep-Dive Investigation Moisture sensitivity in pharmaceutical formulary development is a critical factor that can lead to significant regulatory scrutiny, especially concerning excipient data.…

Functional performance failure during formulation development – preventing late-stage reformulation

Addressing Functional Performance Failures during Formulation Development: A Structured Investigation Approach Functional performance failures during formulation development are critical occurrences that can lead to extensive disruptions in the pharmaceutical manufacturing…

Unjustified excipient choice during regulatory review – CAPA for formulation failures

Addressing Unjustified Excipient Choices During Regulatory Reviews: A Comprehensive Investigation Approach In the realm of pharmaceutical manufacturing, the selection of excipients is a critical factor influencing product quality, safety, and…

Excipient incompatibility with API during scale-up – preventing late-stage reformulation

Understanding and Investigating Excipient Incompatibility with API During Scale-Up In the realm of pharmaceutical manufacturing, the transition from laboratory-scale production to full-scale commercial output can surface significant challenges, particularly concerning…

Functional performance failure during formulation development – compatibility study expectations

Investigating Functional Performance Failures During Formulation Development: Addressing Compatibility Study Expectations Functional performance failures during formulation development can disrupt production and lead to significant quality concerns. These failures often manifest…

Moisture sensitivity overlooked during stability assessment – compatibility study expectations

Investigating Overlooked Moisture Sensitivity in Stability Assessments for Pharma Products In the pharmaceutical industry, ensuring the stability and compatibility of raw materials, especially excipients, is crucial. However, moisture sensitivity is…

Excipient incompatibility with API during supplier qualification – preventing late-stage reformulation

Addressing Excipient Incompatibility with APIs During Supplier Qualification Excipient incompatibility with active pharmaceutical ingredients (APIs) during supplier qualification can lead to significant challenges, including increased costs and delays in product…

Moisture sensitivity overlooked during formulation development – CAPA for formulation failures

Understanding the Risks of Overlooking Moisture Sensitivity During Formulation Development In the pharmaceutical industry, overlooking moisture sensitivity during formulation development can lead to significant deviations, compromised active pharmaceutical ingredient (API)…

Functional performance failure during formulation development – risk assessment for excipient choice

Assessing Functional Performance Failures in Formulation Development through Excipient Risk Evaluation In pharmaceutical manufacturing, functional performance failures during formulation development can severely compromise product quality and regulatory compliance. Understanding how…