FDA Submission: All in the Preparation
Posted on Mar 29, 2017
In our business, GLP (good laboratory practices) is a common term. What does it really mean and what does a lab that adheres to GLP specifically have to offer?
A GLP laboratory provides a validated test method using standards and requirements expected by the Federal Drug Administration (FDA). The goal for all qualified labs is to adhere to standards that ensure clients – you – the highest quality study. What this means is that every analysis is consistent, there are no changes or variables that could affect the outcome of the test results.
Following GLP standards are critical in the pharmaceutical industry. It is a time-consuming process, largely for the preparation of the study, including SOPs, protocols, and additional documentation such as Certificates of Testing. For example, just the process of sample receipt includes a chain of custody form for signature, a recording of the temperature (when required) and many other forms depending on the sample. All require Quality Assurance reviews within the system.
Since adherence to the GLP standard is meant to provide a mutual definition for quality through the audit process, maintaining the Laboratory equipment calibrated to these standards is mandatory. In addition, redundancy of equipment is necessary to prevent any delays or aborted studies in case of an equipment failure. Like many labs, Marin Biologic Laboratories stays on top of trends both in the scientific world as well as the technical.
For Marin Biologic Laboratories, to be a GLP facility means more than just adherence to guidelines. For some labs, GLP is sufficient, for Marin Biologic Laboratories, GLP is just the start. We call it our meticulous and disciplined approach. We take our client’s projects personally. We are as committed to the success of your company and your projects as you are. We make sure all steps taken on your project were done in accordance with the highest standards available in the industry at the time and the highest scientific scrutiny.
We struggled to find the best metaphor to describe how our clients consistently get more than what they pay for whether they do NOT require GLP standard. We decided it was like eating lunch at a five-star restaurant.
Lunch is often a simpler meal than dinner, a burger, an elegant sandwich, iced tea instead of wine, bright daylight. The dining experience may be a bit different, but the food, no matter what is ordered off the menu, will be superior just because it comes out of a five-star kitchen. That sandwich benefits from the surrounding, expertise, innovation, and flavors that are created by the in-house star chef.
A notable chef in the kitchen means all food from the duck confit to the burger, is thoughtfully elevated and deliberately prepared. That’s what it’s like to work with Marin Biologic Laboratories whether your needs are GLP or otherwise.
“We vividly understand our responsibility with a scientific project and want to succeed at achieving the client’s next goal. We liken it to the value we are honored to add to the project.” Tania Weiss, Ph.D., Marin Biologic Laboratories founder/CEO.
Even if it’s a seemingly simple assay, any project benefits from the approach and systems that have FDA awareness and compliance blended in.
Want to Hear More?