According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.” The FR Notice also provides additional background on its thinking in making the revisions to the draft guidance.  Read more... (440 words, 1 image, estimated 1:46 mins reading time)

With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training. Certainly progress has been made in adopting some 800-compliant practices; for example, most facilities already segregate their HD inventory from non-HDs in storage. However, other recommended practices are far from widespread; for example, few hospital pharmacies conduct HD spill simulations and wipe analyses on a regular basis. As such, many facilities do not have a firm understanding of the impact of HD contamination in their facility, nor can they be assured that their staff will respond properly when an HD spill inevitably occurs.  Read more... (467 words, 8 images, estimated 1:52 mins reading time)

Whether isolator or clean room based working areas, if were talking about both sterile and hazardous sterile preparations we recognize the first source of contamination and exposure risk.

The first known, is actually outside of the clean room and is the pre-cleaning station.  Read more... (680 words, 1 image, estimated 2:43 mins reading time)