This FAQ paper is a follow up to the webinar, Leveraging Microbial Contamination Monitoring Data for Actionable Insights to Meet and Exceed the Auditorās Expectations. Questions submitted during and after the webinar are answered in this paper.
Mass-produced pharmaceuticals have come far since the industrial manufacturing of synthetic drugs at the end of the 19th century with rapid advancement in technology, process control, and sterility requirements. Yet even as improvements to Pharma develop, recalls still occur with regularity and their significant impact on both the manufacturer and consumer are why worldwide regulation of the industry is so enforced. Environmental monitoring (EM) is one facet of the greater picture of current good manufacturing practices (cGMPs) that has been standardized for the safety of human health.
This FAQ paper is a follow up to the webinar, āISO EN 17141 & ISO 14968 Overviewā.Ā
Some questions covered in this paper are
Is there any guidance or requirement that applies in a quality control laboratory? Or are they only applicable for cleanrooms in manufacturing areas?
How do I check the particles in nitrogen gas, and what are the specifications?
In May 2021, a revision to USP <1788> Methods for Determination of Subvisible Particulate Matter was published in order to provide clarification and support of the information given in chapters USP <788> Particulate Matter in Injections, USP <789> Particulate Matter in Ophthalmic Solutions, and USP <787> Sub-visible Particulate Matter in Therapeutic Protein Injections. While the previous version of USP <1788> only covered the testing requirements for Optical Light Obscuration testing and Microscope testing, the revision expands the scope of testing requirements to include newly viable technologies such as Flow Imaging and new therapeutic protein solutions. Particle Measuring Systemsā(PMS) APSS-2000 testing system still fully complies with the requirements for use in the testing of solutions in the Normative Chapters and revised General Chapters.