Tag: formulation

Dealing with Inadequate Justification of Design Space in Regulatory Submissions In the pharmaceutical industry, the regulatory scrutiny during submissions can be a critical juncture in the journey from formulation development…

Preventing Validation Failures: Managing Process Transfer Issues During Pilot Scale In pharmaceutical manufacturing, transferring processes from pilot scale to full production is a critical juncture that can significantly affect product…

Managing Non-Transferable Processes During Validation: An ICH Q8/Q11 Playbook In the realm of pharmaceutical manufacturing, the alignment of development processes during validation can be a significant challenge. This issue often…

Addressing Excessive Process Variability During Lifecycle Optimization: A Practical Playbook In the pharmaceutical industry, process variability can pose significant challenges during the lifecycle optimization of drug products. When variability exceeds…

Framework for Improving Process Robustness When CPPs Are Not Well Defined In pharmaceutical manufacturing, poorly defined Critical Process Parameters (CPPs) during development studies can significantly hinder process robustness and regulatory…

Improving Process Robustness for Inadequate Control Strategies during Pilot Scale In the landscape of pharmaceutical manufacturing, the transition from lab-scale to pilot-scale production often uncovers inadequacies in control strategies. This…

A Practical Playbook for Addressing Process Variability During Regulatory Submissions Process variability exceeding established limits can hinder regulatory approvals and increase the risk associated with product launches. This variability can…

Addressing Inadequate Control Strategies during Pilot Scale Development in Pharma The transition from lab-scale to pilot-scale manufacturing presents unique challenges, particularly related to control strategies that may be inadequate, exposing…

Actionable Playbook for Addressing Inadequate Control Strategies During Development Studies In the pharmaceutical sector, a control strategy that is inadequate during development studies can lead to significant regulatory and operational…

Strategies for Managing Non-Transferable Processes in Validation Planning In the realm of pharmaceutical manufacturing and quality assurance, the transfer of processes between different stages of development or facilities is a…

Ensuring Process Transferability During Pilot Scale: Key Data Expectations In pharmaceutical manufacturing and development, achieving a seamless scale-up from laboratory to pilot scale is critical for ensuring later-stage regulatory success.…

Managing Process Variability During Pilot Scale Operations: A Practical Playbook In pharmaceutical manufacturing, particularly during pilot scale operations, the risk of process variability exceeding established limits poses severe regulatory scrutiny.…