Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Clare Naden
One way is through a system of conformity assessment to ISO standards
Sheronda Jeffries
Inclusion of ISO 13485 certificates in IAF CertSearch could help protect first responders
Stephen M. Hahn
The FDA examines new ways of building the science to inform public health decisions
Richard Harpster
Design failure mode and effects analysis (DFMEA) and a look at better masks to prevent spread of Covid-19

More Features

FDA Compliance News
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals

More News

Peter Marks

FDA Compliance

The Center for Biologics Evaluation Keeps Biological Product Standards High

A laboratory quality management system is key

Published: Thursday, March 3, 2016 - 13:26

Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the center as the preeminent regulatory organization for biologics. One way CBER is achieving this is through the work of the Office of Compliance and Biologics Quality (OCBQ) and the Office of Vaccines Research and Review (OVRR).

These offices play a major role in helping to ensure the safety and quality of products regulated by CBER. Their work shows that CBER isn’t just talking the talk about its vision, it’s also walking the walk to demonstrate the expertise needed to fulfill it.

That walk leads directly to OCBQ’s Division of Biological Standards and Quality Control (DBSQC), OVRR’s Laboratory of Immunobiochemistry (LIB), and the center’s Laboratory Quality System (LQS) Program.

LQS is the coordinated structure, procedures, processes, and resources that the center uses to evaluate and test CBER-regulated biological products. LQS product testing supports biological product licensing, lot release, and surveillance of licensed biological products and other center actions. The LQS program is also critical to the development and evaluation of reference materials, standards, and manufacturers’ assays. This extensive responsibility makes LQS an important link in the chain of regulatory actions that support CBER’s mission to help ensure the safety, purity, and potency of biological products.

CBER is authorized by law to create regulations that authorize OCBQ and OVRR to oversee facilities that manufacture CBER-regulated biological products. CBER leaders wanted to go further in demonstrating the center’s commitment to quality systems, and decided to voluntarily submit their LQS program to accreditation by an unbiased, nongovernmental, and nonprofit third party: the International Organization for Standardization (ISO).

ISO sets laboratory accreditation standards for academic and industrial organizations worldwide. Laboratories that receive ISO accreditation can rightly state that their test results are precise and reproducible. OCBQ and OVRR accepted the challenge to ensure that their work meets high, internationally recognized standards.

The particular standard CBER sought to meet, ISO/IEC 17025:2005, is used by testing and calibration laboratories. In the United States, industry laboratories can get accredited to ISO standards by one of many accrediting bodies. CBER turned to the American Association for Laboratory Accreditation (A2LA).

In 2010, CBER received accreditation from A2LA for six methods to test influenza vaccines, including those for sterility and potency, and seven methods for evaluating blood donor screening kits that detect the presence of HIV, HBV, HCV, HTLV-I/II, Trypanosoma cruzi, and West Nile virus.

Additional methods have been accredited since then. CBER’s recent accreditation renewal, in October 2015, demonstrated the center’s competence in 32 test methods previously accredited and added a new laboratory test: evaluating a cELISA allergen test used by CBER for cat hair, ragweed, and dust mites in the newly accredited Laboratory of Immunobiochemistry.

These laboratory accreditations signify that this program is an international leader in biological product regulation based on demonstrated expertise in these laboratory techniques. Further, they offer more evidence that CBER’s goal of being a preeminent regulatory organization isn’t just a vision, it’s a reality that CBER and the FDA can be proud of.

Discuss

About The Author

Peter Marks’s picture

Peter Marks

Peter Marks, M.D., Ph.D., is director of FDA’s Center for Biologics Evaluation and Research.