Five best practices to ensure quality active pharmaceutical ingredients

May 31, 2024

Remove from favorites

Add to favorites

The global market for active pharmaceutical ingredients (API) was valued at approximately $173 billion in 2020 and is projected to reach $286 billion by 2027, driven by the demand for COVID-19 vaccines, oncology drugs, and novel formulations. Ensuring the highest quality of APIs is crucial for patient safety and effective treatment.

Pharma companies must take five key measures to maintain high-quality API supply:

1 - Conduct Thorough Batch Reviews: Begin by reviewing batch release specifications and conducting comprehensive audits to ensure suppliers meet quality requirements and global regulations.

2 - Assess cGMP Compliance: Ensure that suppliers follow robust, risk-based, and error-free current good manufacturing practices (cGMP).

3 - Aim for Continuous Improvement: Implement new processes and technologies to address any identified weak spots and stay aligned with current regulations.

4 - Excellence is a Process: Embrace manufacturing excellence organization-wide using Integrated Manufacturing Excellence (IMEx) principles, ensuring consistent and rewarded outcomes.

5 - Test API Effectiveness and Safety: Use Quality by Design principles to ensure effectiveness and safety, and consistently test batch quality over time to identify issues early.

These measures help ensure that API suppliers meet expectations, enabling pharmaceutical companies to deliver high-quality, effective medicines. Working with experienced API suppliers like Pfizer CentreOne supports the delivery of groundbreaking therapeutics that improve patients' lives.