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Navigating Stability Challenges When Switching Your Manufacturing Provider

Dec 11, 2024 | Published by 

Switching manufacturing providers can be a strategic move to enhance production capabilities, reduce costs, or scale operations. However, this change can introduce significant challenges to product stability, and stability studies, potentially affecting the safety, efficacy, and quality of your pharmaceutical products. Understanding and mitigating these impacts is crucial to ensuring continuous compliance and product success.

Key Impacts of Changing Your Manufacturing Provider:

Variability in Manufacturing Conditions:
    • Even with stringent standards, different manufacturers may have subtle variations in processes, equipment, and raw materials. These variations can affect product stability, leading to unexpected degradation or changes in product performance.
    Regulatory Repercussions:
    • Regulatory bodies, including the FDA and EMA, require consistency in stability data when manufacturing changes occur. Any discrepancies can prompt additional reviews, audits, or delays in product approval.
    Potential Delays in Time-to-Market:
    • Transitioning to a new provider may mean redoing or modifying existing stability studies to align with the new conditions. This can delay product launches or market supply, affecting revenue and competitive positioning.

Stability Studies Whitepaper

How to Mitigate Stability Studies Risks:

  • Engage an Independent Stability Partner: Partnering with an independent stability provider like Broughton ensures that stability studies remain impartial and compliant during a manufacturing change. Our dedicated team conducts thorough investigations and advanced testing to assess the impact and maintain data integrity.
  • Conduct Bridge Studies: Use comparative stability studies to bridge data between the old and new manufacturing sites, identifying potential changes in stability profiles.
  • Ensure Comprehensive Data Management: Full data ownership and secure, real-time access via platforms like Broughton’s proprietary LIMS, LabHQ, can facilitate seamless transitions without losing crucial data.
Switching manufacturing providers is not without risk, but with the right strategy and independent stability support, it is possible to maintain product integrity and compliance. Broughton’s expert team is here to guide you through this transition, ensuring stability data remains robust and reliable.