Five Best Practices to Ensure Quality Active Pharmaceutical Ingredients

The global market for active pharmaceutical ingredients (API) was valued at approximately US $173 billion in 2020, and is expected to reach US $286 billion by 2027.

Key drivers behind this growth have included the soaring demand for APIs for the COVID-19 vaccines, as well as for other therapeutic areas such as oncology drugs and novel formulations that target niche therapeutic areas.

The utmost care is required to ensure the safety of APIs to provide patients with the highest possible quality of treatment that meets their therapeutic requirements.

Here, we’ll explore the five key measures pharma companies must take to ensure the highest quality supply of their APIs.

Read the full discussion between Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs at Pfizer CentreOne in the latest piece with PharmTech:

1. Conduct a thorough batch review

Ensuring a robust API supply is critical for pharmaceutical companies, and manufacturers around the world shoulder a tremendous responsibility to assure the quantity, quality, and continuity of supply.

The first step in any supplier acquisition journey should begin by conducting a thorough review of batch release specifications. Doing so will ensure that your supplier can meet your specific needs.

Next, a comprehensive audit should be conducted to determine if the supplier meets your quality requirements, such as their cGMP (current good manufacturing practice) records and the global regulations they adhere to.

Maintaining this level of care and scrutiny must remain an ongoing priority to make sure that quality is sustained

2. Assess cGMP compliance

Pharmaceutical companies outsourcing their APIs from a supplier are obligated to assure the highest quality of their products, regardless of where their API is manufactured.

The cGMP quality systems followed throughout the manufacture of these APIs should be examined to ensure that they are robust, risk-based, and error-free.

The quality of an API is only as good as the specifications it is based on, so a comprehensive audit should verify that the quality systems used by your suppliers have resulted in cGMP-compliant APIs.

3. Aim for continuous improvement

Always aim to improve the quality of your APIs by implementing new processes based on any weak spots identified in the audit.

This might mean introducing new manufacturing processes and technologies, improved data management systems, or updated training programs for staff.

Regulations and guidelines, such as GMP and Occupational Safety, Health, and Environment (OSHSE), are subject to regular review and revision, so this should be a continuous process to ensure your API supplier remains aligned with the most current guidelines.

4. Excellence is a process

Manufacturing excellence should be supported by processes and procedures that are embraced organization-wide. The tenets espoused by IMEx (Integrated Manufacturing Excellence) serve as the blueprint for a production system system that mandates a common way of working, applies that at all levels, and rewards individuals, teams and facilities on their outcomes.

Pfizer CentreOne is sponsoring a manufacturing excellence track at CPHI Worldwide in Frankfurt, Germany this November, where experts from our team will be sharing insights from this crucial best practice.

5. Testing API effectiveness and safety

Implementing controls and processes developed using Quality by Design principles will ensure that effectiveness and safety are built into the manufacture of your APIs.

You should also test the batch consistency year on year or campaign to campaign to ensure it maintains the quality you expect, and identify any quality issues as early as possible.

By following these five steps, you can ensure that your API supplier meets your expectations and enables you to deliver medicines that meet your patients’ complex needs.

Whether your project is biologic or small-molecule, working with an experienced API supplier like Pfizer CentreOne ensures that you maintain the highest quality supply to deliver groundbreaking therapeutics that change patients’ lives.

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