QA issues in radioisotope production for nuclear medicine
QA issues in radioisotope production for nuclear medicine
QA issues in radioisotope production for nuclear medicine
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LFMCong<br />
82701<br />
Our <strong>QA</strong> status<br />
Drug Master File #5531: Production of Sr-82<br />
submitted and ma<strong>in</strong>ta<strong>in</strong>ed active<br />
CGMP guidel<strong>in</strong>es followed <strong>for</strong> an active<br />
pharmaceutical <strong>in</strong>gredient (API)<br />
FDA registered under labeler code 66711<br />
CGMP also used <strong>for</strong> Ge-68 preparation, other<br />
products follow GLP guidel<strong>in</strong>es<br />
<strong>QA</strong> audits per<strong>for</strong>med by the f<strong>in</strong>al product<br />
manufacturer (GE HealthCare <strong>for</strong> Sr-82, Siemens<br />
<strong>for</strong> Ge-68)<br />
Brookhaven Science Associates<br />
U.S. Department of Energy
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