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Why Sweat The Details?

Feb 12, 2014

Complying with mandatory Good Manufacturing Practices (GMPs) can be stressful no matter which vaccine process your biotech, pharmaceutical or medical company undertakes, but that preoccupation can also be reduced. As previously noted, GMPs are regulated by the FDA and fluctuate between broad and narrow, required and recommended. With the Code of Federal Regulations acting as a compliance manual, firms are expected to validate that their processes and products are safe, effective and protected.

Two regulations of particular relevance to vaccines are 21 CFR Part 10.11 and Part 11. First conceived from the National Childhood Vaccine Injury Act (NCVIA) of the late 1980s, Part 10.11 provides requirements for vaccine labeling and breaks down the process review as follows:

     - Proposed labeling must be submitted for pre-approval

     - Package inserts must be included with submission

     - Inserts must have sufficient instructions, warnings and precautionary information

     - Post-approval surveillance based on medical literature and mortality reports determines whether labeling must be updated

Added in 1997 and refreshed in 2003, 21 CFR Part 11 specifically deals with the collection and storage of electronic records and signatures:

The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures and handwritten signatures executed to electronic records to be trustworthy, reliable and generally equivalent to paper records and handwritten signatures executed on paper.

The FDA monitors these electronic entries by requiring that, among other things, the following major components be accessible and accountable:

     - Validation of temperature parameters

     - Auditable data and action logs

     - Record protection

Failure to provide adequate and consistent electronic documentation may lead to a compliance violation, but such regulatory hassles are avoidable. Technological advances in wireless temperature monitoring have made CFR compliance less intensive than ever. Through device and system automation, you can set temperature boundaries and receive e-mail, SMS, and phone alerts if they are breached. Additionally, all actions and records are time stamped, logged and stored within a secure cloud service. Your company’s ability to adhere to GMP guidelines will be one less concern in your day, which is what truly matters.

Like any regulatory standard, the demands of GMPs are numerous, and an infraction costly, but with a proprietary wireless monitoring device and complementary system, you don’t have to sweat the details.

We’ll continue with pharmaceutical products and their respective CFRs next week.

Free Guide for Vaccine Monitoring

Full disclosure: This writer is employed by one such supplier of wireless temperature monitoring systems, Temperature@lert, that help its users to meet complaince.

Temperature@lert’s ZPoint Cellular Edition ensures that important electronic records (temperature and time logs, alerts, and alert responses) are documented and retained for one year within our Sensor Cloud service. Should the environment you’re monitoring lose power, the ZPoint Cellular Edition’s internal backup battery will keep the device and sensors operational for several days, allowing alerts and measurements to continue without interference. For more information about Temperature@lert’s Cellular and Sensor Cloud offerings, visit our website at or call us at +1-866-524-3540.

Temperature@lert Cellular Edition

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