Regulatory Requirements for Preformulation

FDA initiatives and other government regulations influence pharmaceutical manufacturing operations, including preformulation studies and quality control systems. These regulatory issues include the topics outlined below. 

GLP regulates all nonclinical studies and was originally intended for toxicity testing only. The requirements of analytical measurements and methods in support of toxicological studies are included in the GLP. The QA/QC may serve as the quality assurance unit (QAU), which is responsible for monitoring each study to ensure that management facilities, equipment, personnel, methods, practice, controls, SOPs, and final reports conform to the regulation. 

The ICH is intended to avoid duplication efforts for product registration and manufacturing in world trade. The FDA has been working in a forum 

Ultimately, there will be one set of global requirements. The areas of interest for harmonization include the following topics  

The following areas of involvement are the responsibility of the analytical laboratory where most of the preformulation data are generated. 

---