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Corporate SOPs to govern two manufacturing plants consistent with Q7 |
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Site SOPs specific to each locations operations |
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Chemists specifically trained for manufacturing under cGMP |
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QA/QC staff at both manufacturing plants |
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QC testing and QA release of all raw materials |
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Production Batch Records in English at both sites |
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Qualified facility, utilities and equipment |
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QA physical control of documents and drug substance |
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Seasoned Quality staff; over 40 QA staff and consultants who all have established PAI experience |
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