Navigation Links
Medicines quality workshop to address standards for microbiological contamination, bioburden control

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 workshop will feature a discussion on product quality requirements as they relate to patient risk. Speakers from the U.S. Food and Drug Administration (FDA), USP and industry will address how standards and regulations should be based on quality requirements for pharmaceutical products that reflect the risk associated with their administration to patient populations.

Rapid sterility tests as alternatives to traditional sterility tests based on microbiological growth will be the focus of another workshop session. Conventional tests for product sterility typically require a 14-day incubation period to allow for microbial growth and enumeration. However, in many circumstances, sterile products―which include cell-based therapies, radiopharmaceuticals, regenerative medicines and some compounded drugs―must be made and administered to a patient within a short amount of time; at times, a 14-day sterility test is not feasible. Workshop participants will discuss rapid methods as alternatives for sterility testing based on microbiological growth and will receive an update on USP's proposed general chapter on rapid sterility tests. Also included is a roundtable session which will address recent contamination-related issues in sterile compounding.

USP is currently engaged in developing general information chapters providing detailed guidance for specific sterilization processes for official adoption in USP's compendia of published standardsthe United States Pharmacopeia and the National Formulary (USPNF). Updates on the current status of these general chapters will be provided during the workshop. An additional workshop session on bacterial endotoxins will include discussions on FDA's 2012 question and answer guidance on pyrogen and endotoxins testing, issues to be considered in endotoxin limits for large volume parenterals and USP's standards-setting activities related to depyrogenation.

Registration is available at a rate of $900 for industry and $450 for associations/government/academia. Group discounts are also available. For information about the workshop, go to: For a videotaped interview on the workshop with the chair of USP's Microbiology Expert Committee, go to:

Members of the media interested in registering for the event for free may contact Theresa Laranang-Mutlu at


Contact: Theresa Laranang-Mutlu
US Pharmacopeia

Related medicine news :

1. Growing medicines in plants requires new regulations
2. Zane Benefits Publishes Information About Over-the-Counter (OTC) Medicines, Drugs and HRAs
3. Popular pain-relieving medicines linked to hearing loss in women
4. Strategy developed to improve delivery of medicines to the brain
5. Toward medicines that recruit the bodys natural disease-fighting proteins
6. New research reveals extent of poor-quality antimalarial medicines in South American countries
7. New technology represents next-generation tool for detecting substandard and counterfeit medicines
8. Nanomedicines promise fewer side effects in treating cancer
9. Nearly 1 in 4 grandparents store prescription medicines where children can easily find them
10. Not taking gastroprotective drugs prescribed with anti-inflammatory medicines
11. DNA Testing Finds Allergens, Toxins in Traditional Chinese Medicines
Post Your Comments:
(Date:12/1/2015)... ... 01, 2015 , ... Physicians’ Education Resource®, LLC (PER®) ... announced that the first annual School of Gastrointestinal Oncology™ (SOGO™) will be held ... treatment of gastrointestinal cancers are undergoing transformational change, providing oncologists with powerful new ...
(Date:12/1/2015)... ... December 01, 2015 , ... Speech and ... believe that with innovative technologies and under the right circumstances, these practices can ... benefit of a dual-approach to his or her therapeutic sessions, as well as ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... the 7th Annual 2015 Golden Bridge Business Awards under the New Products and ... zero capex web based sample management software that helps labs organize ...
(Date:12/1/2015)... ... December 01, 2015 , ... The importance of volumetric ... the focus of numerous abstracts accepted for presentation here, at the 101st Annual ... abstracts highlight the use of Volpara Solutions’ quantitative breast imaging software tools for ...
(Date:12/1/2015)... ... December 01, 2015 , ... SAN FRANCISCO, Calif. ... that the organization has awarded Education and Developmental Therapies (EDT), an Applied Behavior ... award celebrates exceptional special needs providers that excel in synthesizing the areas of ...
Breaking Medicine News(10 mins):
(Date:12/1/2015)... 2015 ... "Medium Molecular Weight Polyisobutylene Market for ... Applications - Global Industry Analysis, Size, Share, ... report to their offering. --> ... of the "Medium Molecular Weight Polyisobutylene ...
(Date:12/1/2015)... -- Royal Philips  (NYSE: PHG, AEX: PHIA) ... that produces high-contrast images for all anatomies in situations ... the 2015 Radiological Society of North America Annual ... digital imaging solution providing grid-like contrast improvement and enhanced ... supports "first-time-right imaging" by decreasing the need for retakes ...
(Date:12/1/2015)... WASHINGTON , Dec. 1, 2015  Athletic ... its founder have agreed to pay $1.35 million ... deceptively advertised the company,s copper-infused compression clothing would ... by arthritis and other diseases. ... also requires the company and its founder and ...
Breaking Medicine Technology: