FDA CDER/ORA Compliance Policy Guide Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs(CPG 7132a.15) revised 16-April-87. Regards source code and its supporting documentation for application programs used in drug process control to be part of master production and control records, within the meaning of 21 CFR Parts 210 and
211. Accordingly, those sections of the current good manufacturing practice regulations which pertain to master production and control records will be applied to source code. The drug manufacturer therefore is expected to have access to and to review the source code.
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