Five best practices to ensure quality active pharmaceutical ingredients

May 16, 2025

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The global market for active pharmaceutical ingredients (APIs) is growing rapidly, projected to rise from $173 billion in 2020 to $286 billion by 2027, driven by demand for COVID-19 vaccines, oncology drugs, and niche therapies. Ensuring API quality is critical to patient safety and effective treatments.

Five best practices for maintaining API quality include:

- Thorough Batch Review: Carefully assess batch release specifications and conduct audits to ensure suppliers meet quality standards and regulatory compliance.

- Assess cGMP Compliance: Verify that suppliers follow robust, error-free current good manufacturing practices (cGMP).

- Continuous Improvement: Regularly update processes, technologies, and training to align with evolving GMP and safety regulations.

- Manufacturing Excellence: Foster a culture of excellence through standardized, organization-wide procedures, as outlined by Integrated Manufacturing Excellence (IMEx) principles.

- Testing Effectiveness and Safety: Use Quality by Design principles to integrate safety and efficacy into manufacturing, with ongoing batch testing to ensure consistency.

Partnering with an experienced supplier like Pfizer CentreOne ensures high-quality API supply, enabling pharmaceutical companies to meet patients’ complex therapeutic needs.