If I have to open a new GMP facility from an IMP site, may I use the current GMP Quality System in the project step including GMP procedures of the first site? How I can track it, using a change?
Your question is not clear. Do you want to stert new facility to manufacture Investigational Medicinal Product (IMP) manufacturing facility? The general GMP requirements are the same as those required for manufacturing drug products for commercial marketing. However, there are also certain specific requirements for manuf. and packing of IMPs. Please refer EMA and USFDA guidelines for the same.
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