Reference standards qualification report

The testing and qualification of reference standards should continue such that the necessary documentation (internal and external reports, certificates of analysis, stability reports, supporting raw data) is complete from both a regulatory and scientific standpoint at the time of the NDA filing. 

Reference standards enter the laboratories under adequate control. These procedures typically identify approved sources and specify the documentation (certificates of analysis, qualification reports) that must accompany the reference standard into the laboratory. The accompanying documentation must be available during a GMP inspection. 

A detailed qualification report is drafted for a primary reference standard of the active compound less comprehensive documentation is typical of the other standards. Portions of this report may be submitted to the regulatory authorities. The report references the synthetic route for the standard and any purification schemes that were utilized in preparing the pure standard. Other components of this report may include the following ... 

In step 5, the qualification stage, the critical issue is that the protocol for IQ/OQ of the equipment and the facility include the established method and acceptance criteria. The IQ/OQ report should include the maintenance program to keep the equipment in good condition for reproducibility of the product. For qualification of the equipment and process for terminal sterilization, the following standards should be referred to ISO 13408-1 [6] and 11138-1 [7] for general issues, ISO 11134 [8] and 11138-3 [9] for moist heat sterilization, ISO 11135 [10] and 11138-2 [11] for ethylene oxide sterilization, and ISO 11137 [12] for radiation sterilization. 

Environmental design and qualification are described in CESSAR-DC Section 3.11. The Class IE electrical equipment (including pump and valve motors and electrical accessories) of the System 80+ Standard Design is environmentally qualified by the methods documented in the NRC-approyed report CENPD-255-A, Revision 3 (Reference 7). These method are in accordance with the guidance... 

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