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DID YOU KNOW...

That starting January 1, 2008 all electronic submissions to FDA must be in Electronic Common Technical Document (eCTD) format?
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Especially for Pharmaceuticals

Drug companies need to interview physicians well before they go to the FDA for approval, ideally early enough so that physicians' wish lists can be incorporated into clinical trials.
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Especially for Pharmaceuticals


Especially for Medical Devices

The FDA's Postmarket Transformation Team is well into restructuring the way it handles postmarket medical devices. Don St. Pierre, acting associate director for postmarket transformation, talks about the changes his team is making at CDRH.
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Especially for Medical Devices



Especially for Blood / Biologics

The large number of tests now required by the FDA to check for diseases has made the nation's blood supply extremely safe but also more expensive. The price of one unit of red blood cells jumped from $96 in 2000 to $201 in 2004.
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How to Solve the Top Five Batch Record Challenges
By
Oliver Wolf

Life science companies' manufacturing processes should be assets?not liabilities. Although it is surely unintentional, too many companies treat their batch records like liabilities by using manual systems that are cumbersome, slow and often archaic.

The following is a list of five of the most common batch record problems manufacturers encounter and some possible practical solutions.

1. Manual batch operations are inherently slow and prone to error. Errors and omissions in batch operations are inevitable, but the constant checking and rechecking required when batch operations are conducted manually wastes money and slows time to market. As regulations get more complicated, batch records become exponentially larger and more complex, taking more time to prepare and review. Manual data entry from form to form creates lag time between departments and hinders general production processes. Some of the common snags that frequently delay manual batch operations include:

  • Incorrect data entry.
  • Failure to recognize out of spec entries.
  • Missing signatures.
  • Filling out incorrect forms.
  • Sending the wrong form to the wrong person.
  • Forms left incomplete.

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An Introduction to the eCTD

The CTD (Common Technical Document) was proposed by the ICH working committee (the International Conference on Harmonisation) back in the early 1990s and finally agreed upon in November 2000. Its purpose was to provide life sciences companies with a common structure for registering drugs for human use to the regulatory agencies. The FDA was the first agency to adopt the CTD as a common structure for receiving product registrations from companies. Although the CTD submissions were initially delivered in paper, the eCTD (electronic Common Technical Document) was implemented using the same structure but delivered to the agencies in an electronic format with a few additional specific requirements that were not included in the original CTD.

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Upcoming Events

Check out conferences, trade shows, and other events for life science professionals.

PDA/FDA Joint Regulatory Affaris Conference

(Sep. 24-28, 2007)

MD&M Minneapolis Complimentary Event Coupon
(Oct. 17-18, 2007)

View the entire list


Editorial Staff

Know the difference between IDE and IND? Between a 483 and a Warning Letter? How about GMP versus GTP?
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Editorial Staff

We Want Your Feature Articles


GxP Lifeline welcomes articles that are informative, interesting, and useful to life science professionals.
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Editorial Staff

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