BioSciences Quality Testing Forum

Spotlight

Electronic management of EM results in the micro lab: Critical considerations & financial justification

An appropriate microbiological Environmental Monitoring program should be established and used in production and lab facilities for sterile and non-sterile products. “In aseptic processing, one of the most important lab controls is the EM program” (FDA Guidance for ind.). Typical biopharma facilities may have several hundred or thousand environmental samples collected, processed on a daily basis. Most microbial EM programs generate a voluminous amount of data and require a large amount of time from the QC labs. Companies may consider acquiring data storage & management systems. This Spotlight addresses the critical points to look at when considering implementing a paperless EM data management solution.

Click here for more... - Comment the topic

Industry News

Click here for more...

Events

Click here for more...

Product Information

Click here for more...

Opinion Poll

Microbial ID Methods - What are you using as primary method?

  • Gram stain
  • Phenotypic
  • Proteotypic
  • Genotypic

Surveys

Participate in our Survey and share your experience with our Community. It takes only minutes to complete and is anonymous.

Microbial Air Monitoring - Tools and Methods

Click here to start

Results will be presented to the Forum.

Send your suggestions of topics for Spotlight and Survey to Topic@BioQTforum.com.

PREVIOUS SURVEYS

- Microbial ID 

- BET

To get a copy of the results, please contact us

Company Directory

Click here for more...

Featured Events

Oct. 14 - RMM Workshop: Critical aspects & recommendations for a successful implementation - San F

Nov. 1-3, 2010 - BioPharma Manufacturing & development summit - Boston, MA

Click here for more events...

Resources

Click here for more...

Regulatory Support

  • USP <1111>
  • USP <61>, USP <62>
  • USP <71>
  • USP <1223>
  • EP <5.1.6>
  • EP <5.1.3>
  • FDA. Guidance for ind.: PAT
  • FDA. cGMPs for the 21st c.
  • PDA TR#33

Click here for more...

Newsletter

Stay in touch with the analytical methods and equipment latest updates and news.

Sign up for our Email Newsletter

Enter email address:

Contact Us

Readers: Please contact us at Info@BioQTforum.com

Advertisers: You are interested in highlighting your products or services with banner ads, text information, videos, webinars, podcasts, etc. Please contact us at Marketing@BioQTforum.com