Accelerating Quality: How to Partner Successfully for Rapid, Compliant Microbiological Testing

Sterile injectable product formulations—ranging from biologics and small molecules to compounded preparations—are increasingly complex and tailored to meet specific therapeutic needs. Many require rapid turnaround times for critically ill patients, adding pressure to ensure safety without delay. The unique nature of these products presents significant challenges in quality control and regulatory compliance. To ensure the sterile injectable products are free from microbial contamination, pyrogenic substances, and sub-visible particles that could pose risks to patient health, they must meet stringent safety standards.

Establishing a successful partnership with a qualified testing provider is critical to navigating these challenges. Such collaboration ensures that appropriate methods are implemented effectively, testing is performed under compliant conditions, and products reach patients safely and swiftly.

Ultimately, balancing the urgency of patient needs along with the rigor of pharmaceutical testing demands a strategic approach—one that embraces innovation while upholding the highest standards of quality and compliance.

In this webinar, we will discuss: 

• Understand compendial testing requirements for sterility testing, bacterial endotoxin testing, and sub-visible particulate matter testing—and what your testing partner needs to know.
• Identify key attributes of a successful partnership that supports compliance and efficiency.
• Explore critical factors when selecting and outsourcing to a testing lab.
• Review current regulatory expectations for both pharmaceutical manufacturer and testing providers.

Register now