ISPE recently issued the third edition of the Oral Solid Dosage Baseline guide. The guide was revised over a period of time to provide more clarity and definition to the manufacture of Oral Solid Dosage (OSD) Products. Within the body of the guide is a section which provides definition on the risks associated with the manufacturing of OSD products, whether they are tablets, capsules, creams ointments or any of the other varied products which fall under the OSD framework.
There is a significant difference between the manufacturing of OSD products and Aseptic products. Aseptic products are injected directly into the bloodstream, requiring a significantly higher level of cleanliness and sterility in the manufacturing process. OSD products are ingested or directly applied to the skin. The OSD products work through your bodies processes before they can impact your systems, taking an indirect path, as opposed to Aseptic product which takes a direct path.