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Comparatively Speaking: cGMP vs. ISO
By: Anthony J. O'Lenick Jr., Siltech LLC
Posted: August 31, 2010
page 3 of 3
How might cGMP and ISO requirements impact formulators? By understanding the requirements for product specifications up front, especially in relation to QC and QA, formulators can build formulas that take the methods by which products will be scaled up and processed into account, thus avoiding potential issues of noncompliance that could arise in later stages.