When developing or testing medical devices, there is always the question: are you following the right methods for current Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP)?
When developing or testing medical devices, there is always the question: are you following the right methods for current Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP)? In this handy guide, we have compiled a list for you to follow to give you peace-of-mind on this tricky topic of compliance in the lab. Quality systems and standards regulating product development and manufacturing of medical devices, pharmaceuticals, and the way clinical studies are conducted, require the appropriate and technically valid standard operating procedures are all followed, and a regular, documented maintenance and calibration process is set in place for all lab equipment, including pipettes. In this guide, we’ll look at a few tools and principles that could help with these demanding requirements, especially when it comes down to your pipetting techniques.
Ensuring Standard Operating Procedures are All Followed
Ensuring that the right and technically valid SOPs are followed is a huge requirement for GLP and GMP compliance. This means repeating the set work instructions without any deviations. Many other workplace processes are already fully or semi-automated, and this type of assistance is also available for bench work. Electronic pipettes can be used to simplify and speed up workflows by allowing the integration of SOPs to programmable pipetting protocols. Once activated, the program will automatically adjust the parameters after each step that is completed. This cuts back on the possibility of human error that is apparent when manually adjusting your pipette parameters.
Documentation and Audit Trials
Electronic pipettes from Sartorius can be used to simplify and speed up workflows any allowing the integration of SOPs to programmable pipetting protocols. Electronic pipettes offer the unique bonus of an audit trial which will provide a report of operation with time and date stamps. Electronic pipettes can be password protected and assigned to a specific user. All this documentation is valuable for quality compliance.
Never Miss a Calibration Due Date
Has somebody in your lab ever forgotten to calibrate their pipettes before calibration? Most labs use sticker labels on their pipettes, but they’re far inferior in helping you remember than your calendar notifications you use. Some electronic pipettes, like the Sartorius Piscus NxT, could be set to enforce proper calibration interval by using a calibration reminder option. With the help of the reminder, you’ll be aware of the pipettes in the lab with expired calibration dates, saving you from plenty of frustration.
In Summary…
GLP or GMP compliant pipetting can be achieved by creating a pipetting quality control program, according to industry best practices, and by equipping all labs with electronic pipettes from Sartorius that can be programmed according to SOPs and work instructions to remind users to perform periodical calibration and maintenance. If you have any questions about your pipette’s quality program, give our metrology team a call!
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