Production of Phase 1 Clinical Trial Supplies Using a USP 797-Compliant/High-Risk Certified Pharmacy

Posted by: DaVita Clinical Research

Since 2008, there has been an exemption to specific regulatory CGMP requirements for certain phase 1 clinical trial supplies, including active pharmaceutical ingredients.  Do you know if your next project may meet the criteria for this exemption?   If so, do you know what to look for when considering pharmacy providers who can meet the criteria?

The final rule published in 2008 states that “FDA believes that production of human drug products, including biological drug products, intended for use in phase 1 clinical trials (phase 1 investigational drugs) should be exempted from complying with the specific regulatory requirements set forth in parts 210 and 211.”  For phase 1 investigational drugs that are intended to be sterile, FDA will accept certain other assurances, such as manufacturing controls, in lieu of CGMP compliance.  FDA still has authority to take appropriate actions to address manufacturing issues, and retains authority to place phase 1 clinical trials on hold, or terminate them, if there is evidence that inadequate control procedures could compromise the safety of the investigational product.  The CGMP exemption does not apply to an investigational drug that the sponsor has made available for a phase 2 or phase 3 clinical trial, or that has lawfully been marketed, and is being used for, a phase 1 clinical trial.

The rule allows sponsor companies to avoid the significant cost and time associated with GMP production in the earliest phases of new product development: “FDA is taking this action to focus a manufacturer’s effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.”

If you have a phase 1 product in development and want to avoid the time and money associated with CGMP manufacturing while fulfilling FDA’s expectations for quality and safety, how do you choose a pharmacy provider for non-sterile to sterile compounding of investigation product?  You have an option here, and what you need to look for is:

  • The pharmacy is state-licensed, ISO certified and meets requirements for USP 797 high-risk compliance.  The site must be ISO certified in order to be USP compliant.
  • The pharmacy staff are properly trained and process validated for sterile process and technique, along with gowning and gloving on a routine basis for non-sterile to sterile compounding.
  • The facility is appropriately designed for non-sterile to sterile compounding, including pharmacy space that meets USP 797 High Risk standards for particulate count and surface sampling for Class 5, Class 7, and Class 8 environment with ISO certifications.
  • The organization has demonstrated the ability to manage the non-sterile to sterile compounding process with complete QA documentation from batch record design to documentation of the process and product, and ideally has extensive previous experience producing clinical trial supplies for sponsor companies.

If you’d like to learn more about our compounding capabilities for clinical trials, read this short case study or view our educational webinar for a more in-depth review.  Or reach out to our VP of Commercial Development,

-Harry Alcorn Jr. Pharm. D., Chief Scientific Officer