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Medicines quality workshop to address standards for microbiological contamination, bioburden control
Date:2/19/2013

February 19, 2013, Rockville, Md. ― Appropriate testing for the presence and growth of microorganisms, training of personnel handling materials and aseptic operating conditions and equipment are just some of the factors associated with the control of microbiological contamination during pharmaceutical product manufacturing. By taking necessary precautions and steps to keep the potential for contamination in check, manufacturers can help to ensure that the quality of their productsand ultimately, patient safetyis not compromised.

On March 18-19, 2013 in Rockville, Md., the United States Pharmacopeial Convention (USP) will host a workshop, "Microbiological Control of Compendial Articles," focused on quality standards related to microbiological contamination and bioburden control. Microbiologists, quality control/quality assurance specialists, compliance personnel and regulatory experts will be on hand to discuss USP's current and proposed standards for microbiological contamination, sterility testing, compounding and other relevant topics. A scientific, nonprofit organization, USP develops standards for the identity, strength, quality and purity of medicines and their ingredients. The workshop will highlight current and proposed USP public standards focusing on topics relevant to microbiological contamination and bioburden control, for sterile as well as nonsterile pharmaceutical products.

"USP's workshops offer stakeholders an opportunity to come to the table and share their current thinking about critical quality issues related to medicines," according to Srini Srinivasan, Ph.D., executive vice president of USP global science and standards. "We are keenly aware of the dramatic impact microbiological contamination can have on drug quality, and having stringent practices for controlling contamination during pharmaceutical manufacturing is one of the most important ways that standards can help to protect the patient."

USP's work
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Contact: Theresa Laranang-Mutlu
trl@usp.org
301-816-8167
US Pharmacopeia
Source:Eurekalert

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