Navigation Links
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 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: http://uspgo.to/microbiology-workshop. For a videotaped interview on the workshop with the chair of USP's Microbiology Expert Committee, go to: http://uspgo.to/Z24jwG.

Members of the media interested in registering for the event for free may contact Theresa Laranang-Mutlu at trl@usp.org.


'/>"/>

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

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:
*Name:
*Comment:
*Email:
(Date:5/6/2016)... ... May 06, 2016 , ... ... charity program created to support and assist the people of their local community. ... with nonprofit organizations and community leaders. Their desire is to bring awareness to ...
(Date:5/6/2016)... Rafael, CA (PRWEB) , ... May 06, 2016 , ... ... an overnight youth rugby camp held at Oregon State University this summer. Employing world-class ... to benefit athletes of all skill levels with training on key fundamentals, match play, ...
(Date:5/6/2016)... PA (PRWEB) , ... May 06, 2016 , ... ... does to reduce fat areas around the body, is the most popular ... survey results just released make perfect sense to cosmetic surgeon Dr. Richard Buckley, ...
(Date:5/6/2016)... ... ... From the Speaker Podium to the Exhibit Floor at Booth#514, Worldwide Leading ... Customers Engagement at SpeechTek 2016 Event, taking place May 23-25 at the Omni Shoreham ... on “5 Customer Engagement Strategies to improve Customer Satisfaction in your Contact Center” ...
(Date:5/6/2016)... ... 06, 2016 , ... Multiple award winning plumbing company in San ... years. Maintaining core values of exceptional customer service, quality work at reasonable rates, and ... name in San Diego plumbing, and other services including heating & air conditioning and ...
Breaking Medicine News(10 mins):
(Date:5/5/2016)... 5, 2016 Progra m m ... of Oxitec , s mosquito in ... by 96 %   Oxitec and ... to fight wild Aedes aegypti, the dangerous mosquito that spreads dengue, ... of Grand Cayman .  MRCU, a global leader in mosquito ...
(Date:5/5/2016)... , May 5, 2016 ... the addition of the  "Europe Thrombocythemia ... 2016"  report to their offering.  ... ) , ,The latest research Europe ... - 2016, provides comprehensive insights into ...
(Date:5/4/2016)... Diversified Holdings (NYSE: CODI ) ("CODI," "we," ... market businesses, announced today its consolidated operating results for ... First Quarter 2016 Highlights , Generated Cash Flow ... of $13.6 million for the first quarter of 2016; ... the first quarter of 2016; , Paid a ...
Breaking Medicine Technology: