Microbiology plays a role throughout the manufacture of pharmaceutical products. Both non-sterile and sterile products are susceptible to the microorganisms they contact during the manufacturing process which may include raw materials, in-process operations and the final product. The environmental and utility systems must also be maintained as must the packaging components, manufacturing equipment, and personnel. To maintain this controlled process and environment, sanitizers, disinfectants and sterilants (sporicides) are essential.
Maintaining this controlled environment also requires knowledge of the microorganisms present and their susceptibility to various sanitizers, disinfectants and sterilants. Whether the final product is non-sterile or sterile, bioburden exists throughout the process and/or within the product's environment. This seminar will illustrate best practices for a critical review of the overall microbiological process, which will determine whether the critical in-process points permit the final product to meet its acceptance criteria.
Whether you are auditing a raw material supplier, a testing laboratory, or your own facilities, you should be aware of the critical role the microorganisms play throughout. This seminar will instruct attendees on the importance of being aware of the various microbiological related documents, e.g., raw material sampling criteria, in-process, API, final product, environmental and utilities, to determine whether the SOPs, internal validations as well as government and other regulatory body documents are being maintained to control the bioburden and permit the final product to enter the marketplace as microbiologically safe.
Note: Use coupon code 232082 and get 10% off on registration.
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