NEB’s Quality Assurance team maintains strict quality standards and recordkeeping, ensuring the traceability and accuracy of NEB’s product data. Below are just a few of the ways in which NEB ensures that its processes are beyond reproach. If you have any questions, please contact firstname.lastname@example.org
NEB holds both ISO 13485: 2003 and ISO 9001: 2008 certifications at its headquarters in Ipswich, MA (USA). Learn more about our ISO certifications on our Certifications
In response to customer need, NEB is moving into the GMP manufacturing space. A new manufacturing facility is under construction, and the first GMP products are expected to be available in 2017. For more details about NEB's GMP products and its new facility, please visit the press release
- Product Certificates of Origin are available upon request.
- Established validation programs for:
- – Specialized products (e.g., NEBNext® Library Preparation kits)
- – Shipping process
- – Automated filling lines
- – Product storage chambers
- – Critical process equipment
- Change Management and Customer Notification of Changes
- Use of a validated 21CFR Part 11-compliant electronic Quality Management Software (eQMS) for Quality records and document control
- NEB has been recognized for the quality of its products; most recently, NEB was awarded a Life Science Industry Award® (LSIA) for its “Molecular Biology Products”, citing both product purity and performance. Additional details can be found in our press release.
- Case studies (>40 available upon request) of the use of NEB products in regulated applications are available. NEB reagents are currently used in the following regulated applications:
- – Molecular Diagnostics
- – Food Safety Testing
- – Animal Health
- – Pharmaceutical QC reagents and starting materials
Expiration Dating Policy
New England Biolabs now has a policy of assigning expiration dates to many of our enzymes and reagents. This policy is designed to satisfy the needs of a growing number of our customers who require such information to meet their regulatory requirements. For such customers, the expiration date indicates the period of time over which NEB will guarantee 100% activity of the enzyme if stored under the recommended storage conditions.*
Our expiration dates have been developed as a result of many years of experience with our products and represent a minimum guaranteed life expectancy for full activity of a given product. It is not the intent of this dating policy to imply that a product will necessarily lose activity after the expiration date. In fact, many of our enzymes will retain significant, if not full, activity for many months or even years after the expiration date. For many basic research applications, enzyme vials may be suitable for use well past their stated expiration date. Disposal and or continued use of enzymes past their expiration dates should be at the discretion of the end user.
* Enzymes should be stored long-term at the recommended temperature (most often -20°C; some enzymes have alternate recommended storage temperatures, such as -80°C). During use, enzymes should be stored on ice, and then returned to their long term storage conditions promptly after use.
NEB uses a barcoding system that allows enhanced tracking of product within NEB, increases the accuracy of our shipping operations and also provides expanded product information for each shipped item.
The barcode (see image below) is based on Code 128 symbology, consists of a six-digit catalog number (eg., R0101S), a seven digit lot number (eg., 0330711), a four-digit expiration date (eg., 0911), and a single digit used for internal tracking of our packaging operations within NEB. For the three pieces of coded information (cat #, lot #, exp. date), the details are as follows:
- catalog # - the standard six-digit system is our standard catalog number.
- lot # - for most products; the first three-digits indicates the master lot. This is followed by a four-digit code referencing the assay or packaging date. Reporting the assay or packaging date allows greater traceability here at NEB. The format will be 3 digits for the master lot, 2 digits for the year, and 2 digits for the month. For some buffers the first three-digits indicates the packaging run and the next four-digits indicates the formulation or packaging date. This is required to help distinguish packaging runs carried out on the same lot in the same month.
- expiration date - this is a four digit sequence, 2 digits for the year followed by 2 digits for the month; for example, 1511 would indicate an expiration date of November 2015.
NEB’s Quality Control team is at the heart of what sets NEB’s products apart from competitors’ – their outstanding purity and performance. Below are just a few of the ways in which NEB ensures its product quality. If you have any questions, please contact email@example.com
A range of standard Quality Controls
are run for each product.
- Stability testing methodology includes:
- – Accelerated testing
- – Freeze/thaw testing
- – Rotational stress
- – Real-time testing
- New product shelf life is set based on accelerated testing, performance of similar products, and verified by real-time testing.
- Fully packaged retains are stored under controlled conditions for one year past expiration date.
- Proprietary methods are developed by Research, Applications and Product Development scientists, and verified by Product Managers and the Quality Control lab.
- Availability of Certificates of Analysis and Product Specifications for custom or catalog products
- Lot-to-lot reproducibility is maintained by concentration measurement, activity measurement and functional testing.
Comparative Ligase Quality Data
NEB’s ligases have been widely adopted by the molecular biology community due to their reliable activity, flexible formulations, and affordable price point. NEB’s ligases undergo several quality evaluations before they are packaged for customer use. For details on the specific quality controls that NEB’s ligases are required to pass, click here
Examples of how NEB’s ligases compare to competetors’, with regard to purity, can be found below.
Comparative Restriction Enzyme Quality Data
NEB’s restriction enzymes have enjoyed a decades-long reputation as being of the highest quality and value. Much of this reputation is owed to NEB’s exacting quality controls for restriction enzyme quality and purity. For details on the specific quality controls that NEB’s restriction enzymes are required to pass, click here
An example of how NEB’s restriction enzymes compare to competitors’, with regard to purity, can be found below.