The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
FDA COMPLIANCE POLICY GUIDE Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (CPG 7132a.15)
Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.