NEB’s Quality Unit is responsible for developing and executing stringent quality standards for NEB’s entire portfolio of products. The structure of the Quality Unit enables a two-tiered approach to evaluating and ensuring product quality. At the compliance level, NEB is guided by the ISO quality certifications that it has been awarded. These standards require a transparent and traceable process, from beginning to end. Certificates of Origin and Change Management are two such processes. At the analytical level, NEB relies on its assortment of cutting-edge quality controls, designed for assessing a product’s physical attributes and confirming the physical purity of finished products.
- NEB’s quality certifications (ISO 13485-2003 and ISO 9001:2008), quality assurance practices, and GMP manufacturing
- Product lifecycle tracking practices (expiration dating and barcoding)
- Industry-leading quality controls
- Examples of product quality across multiple vendors
For questions about NEB’s quality processes for standard and custom products, 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 page.
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
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.
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.
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.