cGMP Compliance

Ensuring You Receive a Continuous Supply of High-Quality, cGMP-Compliant Products

Current good manufacturing practices (cGMPs) are critical to the successful development, formulation, and manufacture of your pharmaceutical product. SPI Pharma has the integrated systems and processes to ensure delivery of safe, efficacious, high-quality products—when and where you need them.

Unlike many other excipient manufacturers, SPI Pharma serves the pharmaceutical market exclusively. Because of this focus, our scientific and regulatory staff has a deep understanding of the stringent quality management controls required to maintain compliance with cGMP guidelines.

We are dedicated to maintaining the highest quality and strictest cGMP compliance in everything we do:

• All manufacturing processes and activities at our sites meet cGMP guidelines. 
• We implement and maintain comprehensive SOPs, rigorous training, and robust process controls throughout our operations. 
• Our regulatory affairs professionals around the world continuously monitor changing regulatory requirements. 
• Our manufacturing plants are regularly audited by both our customers and regulatory authorities. 
• We also conduct our own internal audits on a regular basis to ensure quality control. 
• We are focused on continuous improvement of our processes and products and adapting to the evolving global regulatory environment. 
• We constantly invest in quality to stay ahead of changing regulatory requirements and compliance standards—and our competitors.

When you partner with SPI Pharma, you can be assured of high-quality, cGMP compliant products and expert service and support.