To learn more about what this means for the company, and the steps it took to secure the accreditations, Outsourcing-Pharma.com talked with Dr. Paul Brooker, President of Contract Research and Research and Models Services in Europe.
Outsourcing-Pharma.com: What does the accreditation mean for Envigo?
Dr. Paul Brooker: AAALAC is the industry’s leading organization that advances the cause of humane treatment of laboratory animals. As an organization Envigo holds the enhancement of animal welfare as one of its core values. We will not compromise on the humane treatment of animals and are a strong proponent of the 3Rs – looking for ways to replace, reduce or refine the use of animals in research.
Our CRO business is a leading provider of in-vitro testing, helping the industry develop and validate tests that do not require laboratory animals. When laboratory animals are required by regulatory mandates, however, Envigo employees are trained and inspired to enhance and enrich the health, comfort and overall welfare of the animals with which they work.
So, being accredited by AAALAC is very important to us because it validates our position as a leading proponent of animal welfare for laboratory animals and is at the heart of our values as a company.
Outsourcing-Pharma.com: What steps did the company take in order to secure the accreditation?
Brooker: AAALAC has a rigorous process for granting accreditation to institutions. The process assures that the standards for laboratory animal care and use programs set by AAALAC are met by institutions seeking accreditation. Those standards are detailed in AAALAC’s Guide for the Care and Use of Laboratory Animals.
They are quite detailed, but at the highest level, the standards require organizations, such as Envigo, to demonstrate that they employ qualified and trained animal caretakers as well as maintain facilities and methods of animal care that assure the well-being and comfort of laboratory animals. Through the open exchange of information with AAALAC and on-site visits of our facilities, Envigo was able to demonstrate that we meet those standards.
The steps taken by Envigo to achieve AAALAC accreditations for its Bresso, Italy and Wyton, UK facilities are similar to preparing for quality audits. We needed to assure all of our facilities, policies, documentation and other aspects relating to the humane treatment of animals meet all of the standards AAALAC sets for institutions seeking accreditation.
The first stage of the accreditation involved the creation of a cross-functional Envigo team, which took ownership of the program and collated all the necessary information to write the detailed animal care and use program description required by AAALAC.
The team then reached out for input to all experts within the company who had previous experience with the process of accreditation and extensive knowledge of Envigo’s animal welfare programs. Together, these cross functional teams reviewed and made any necessary changes in policies and standard operating procedures (SOPs).
The teams also requested any physical improvements to the facilities, where necessary, and oversaw their implementation. Fortunately, our facilities are maintained in excellent condition, so we were able to translate the AAALAC accreditation experience into an opportunity to improve general maintenance and further enhance our policies and procedures that advance animal welfare.
Outsourcing-Pharma.com: Could you please describe the quality improvement programs in place?
Brooker: One of the cores values of Envigo is continuous improvement. We are an organization consistently seeking ways to improve quality and efficiency in our work. Those efforts take place at every level of the company and are supported by Quality Assurance and Business Process Excellence teams among other departments.
In our Research Models and Services unit their energy is focused on improving Envigo facilities, technologies, processes, customer service, and the quality of the laboratory animals we provide to our customers.
Outsourcing-Pharma.com: What are the facilities capabilities? How do they promote responsible animal research?
Brooker: Envigo offers a varieity of highly specialized capabilities in these facilitites including contract breeding, assisted reproductive technologies laboratory services, as well as microbiology, immunology and molecular biology testing relating to animal health.
All of Envigo’s services comply with local, regional and federal regulations as well as AAALAC standards relating to the humane treatment of animals in scientific research. The responsible use of animal research is strongly anchored within the values of our company and expressed in Envigo’s global animal welfare policy.
This starts by employing personnel with a strong welfare commitment towards animals, which is furthered by consistent internal and external training & education. Equally important is the advice given by our independent animal welfare and ethical groups, which work at both a global level (the animal welfare committee), but also at a local level in form of IACUCS and Animal Welfare Boards (AWBs). These groups have representatives from all aspects of our business and independent external membership in order to receive the broadest spectrum of ethical input possible.