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Researchers say that as the number of organ transplants continued to increase throughout the world, the number of organ transplant recipients developing skin cancer are increasing, too.  The results of a study on this topic were presented this month In an address to the 66th Annual Meeting of the American Academy of Dermatology (Academy).
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Especially for Pharmaceuticals

At the end of 2007, the FDA announced an amendment to its current GMP regulations for finished pharmaceuticals.  Will your organization be affected by this final rule?
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Especially for Pharmaceuticals


Especially for Medical Devices

For medical device companies the new MDUFMA is likely to result in shorter application cycles and more efficient communication with the FDA.
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Especially for Medical Devices



Especially for Blood / Biologics

Technology is moving to the next level in hospital laboratories and blood banks. With the current shortage of qualified medical technologists, hospitals are introducing instrumentation and automation techniques into the blood bank.
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Especially for Blood / Biologics



Establishing and Operating an Effective GMP Auditing Program
By Robert L. Dana

“Hi, I’m from the Corporate Auditing Group and I’m here to help.” This popular phrase, appropriately modified to reflect the place from where the “helper” comes, is often heard and sometimes associated with Corporate Auditors and Corporate Auditing Groups. No one likes to have their work reviewed and evaluated by an outside pair of eyes, especially when those eyes belong to someone who has been trained to be critical and look for operational inconsistencies and examples of regulatory non-compliance - and worse yet, report on those examples to one’s superiors and senior management. Yet performing an independent assessment of operations, identifying an area of potential concern and ensuring that appropriate and effective corrective actions are taken is critical to ensuring that firms maintain a solid compliance posture and that management is aware of any potential compliance concerns. So who are these Corporate Auditors, how did they come to be what they are, and how do world class auditors and audit groups operate?

To begin with, audit programs should be structured so that the auditors have complete independence of the functions they are auditing. They must also have the complete support of management to ensure they are free to evaluate what they see and hear, and report on their findings without fear of retribution. Corporate audit programs should report to components that are reasonably high within the company organization, again to ensure they have the ability to engage in dialogue with other senior management of their company on an equal footing.

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Pharmaceutical Industry’s Transition from Paper-Based to Electronic Processes

The advantages to pharmaceutical companies of using electronic solutions to modernize their paper-based or partially electronic processes are enormous.  Automation speeds up and connects all interrelated processes (CAPA, customer complaints, audits, deviation management, change control, training, purchasing, etc.).  This eliminates errors due to human oversight and ensures FDA compliance, which requires that strenuous controls be in place for ensuring the identity, strength, quality, and purity of drugs (Section 211.100). 

Automated solutions expedite communication with support service companies, external partnerships, and vendors.  They reduce the time that must be spent in meetings by providing instant access to the most current data and information available.  With a web-based system, current data and information can be accessed from virtually any location in the world.  Automated solutions also help keep executive management well informed by providing access to all company activities, 24-hours a day.  This enhances compliance and helps ensure smooth operations.  With some systems, managers and other authorized users can even view critical path workflows in real time to help avoid potential bottlenecks.

Moreover, companies that automate their processes accelerate the development of new products and reduce the time-to-market for products currently under development. 


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Upcoming Events

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

Interphex / Pharma IT Expo 2008
(Mar. 26-28, 2008)

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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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We Want Your Feature Articles


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