FDA Compliance Policy Guide 425 Computerized Drug Processing, 9/87

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Compliance Policy Guides (CPG) explain the FDA policies on regulatory issues related to FDA laws or regulations. These include current Good Manufacturing Practice (cGMP) regulations. They advise the FDA’s field inspectors and compliance staff as to the FDA’s standards and procedures to be applied when determining industry compliance.

CPG Sub-chapter 425 contains the policies for Computerized Drug Processing and has the following section:

• 425-100: cGMP Applicability to Hardware and Software (formerly CPG 7132a.11)
• 425-200: Vendor Responsibility (formerly CPG 7132a.12)
• 425-300: Source Code for Process Control Application Programs (formerly CPG 7132a.15)
• 425-400: Input/Output Checking (formerly CPG 7132a.07)
• 425-500: Identification of “Persons” on Batch Control and Production Records (formerly CPG 7132a.08)

NOTE: These policies are from 1987