By Sarfaraz K. Niazi pages: 464 | 2009-09-21 / 1420081306 / |
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry.
Highlights from Sterile Products, Volume Six include:
formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications specifications of a manufacturing facility to manufacture compliant sterile products NDA or aNDA filing requirements of sterile products an alphabetical presentation of formulations of pharmaceutical products based on their generic names handbook of pharmaceutical manufacturing formulation, pharmaceutical manufacturing handbook, handbook of pharmaceutical sterile formulation, how products are made an illustrated guide to product manufacturing, pharmaceutical manufacturing formulations, pharmaceutical and clinical calculations second edition, handbook of pharmaceutical manufacturing formulations, handebook pharmaceutical excipients, books autoclave sterile product, manufacturing automation equipment design, handebook pharmaceutical manufacturing formulations second edition sterile product download, cosmetic and toiletry formulations, handebook pharmaceutical manufacturing formulations second edition semisolid products,
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