Many pharmaceutical and biotech companies face the same challenges when it comes to sample management. The backbone of compliance and research is accurate sample management.
Whether you are a biotech start-up or a well-heeled pharmaceutical company, it is vital to your business that you have reliable, dependable, auditable, and compliant sample management in place.
MEETING THE CHALLENGES
Solutions are available that can help to greatly reduce the risk of corrupted samples and avoid the risk of non-compliance. The right biostorage group will have the up to the minute compliant solutions that can help to reduce the risks associated with sample contamination.
VOLUMES OF REGULATIONS APPLY TO PHARMACEUTICAL AND BIOLOGICAL SAMPLE MANAGEMENT
The FDA has developed pages and pages of regulations to improve the safety and integrity of pharmaceutical sample management. Every processing stage of the samples is now regulated, which includes:
- How samples are stored
- Shipping, handling, and chain of custody documentation
- How long samples are to be kept
There are a wide range of regulations in place to provide guidance and mandates on how your samples should be handled during each stage. It can be a challenge to manage compliance without a leading biorepository expert on your team.
Proper management is not only a compliance issue; it also affects the integrity of your overall results. In clinical trials, thousands and thousands of biological samples are collected often from many different locations. These samples need to be stored safely and with accurate tracking in place. Fully compliant management is a necessity to ensure the integrity of the trials. Otherwise, years worth of careful research and investment could be compromised.
Flawless pharmaceutical sample management means flawless results. Your specimens will be properly handled, transported, and stored at all times. You can expect complete traceability of all samples, reliable dispatch of samples when needed, and compliant storage and transportation.
The right team will have all the proper procedures in place to achieve this, from in house cold chain logistics services to state-of-the-art pharmaceutical cold storage. With the right partner, you can take a turnkey approach to sample management.
OPTIMUM STORAGE CONDITIONS
Remember: the optimal conditions for one sample will not be optimal for another. For example, certain biological samples are required to be stored in cryogenic conditions in a secure container that can maintain negative 302-degree temperatures. Other samples may simply need to be kept in a medical refrigerator. Ideally, one storage facility can handle all your sample storage needs. Having one provider that can meet all your needs simplifies control, tracking, and compliance.
CHAIN OF CUSTODY AND DISTRIBUTION
There are clear guidelines for custody and distribution procedures of samples. The right biorepository will have standards in place to ensure these guidelines are followed closely, keeping you and your organization legally compliant.
In addition, you should have easy access to samples and be able to pull necessary information about these materials with ease. The right firm will have policies in place in the event that a sample needs to be transported on short notice.
WITH THE RIGHT PHARMACEUTICAL SAMPLE MANGEMENT PARTNER, YOU CAN FOCUS ON RESULTS
When you choose a trusted biological pharmaceutical facility to manage your samples, your team can focus on getting results and worry less about compliance. To learn more about the benefits of choosing the right team for your sample management needs, contact the Sci Safe team.