Harlan Laboratories is unique among suppliers
of research models and contract research services in the breadth of
our quality programs. These programs include ISO 9000:2001,
ISO 17025, GLP, GMP, and national standards for pharmaceutical
testing. In addition to these quality process programs, Harlan
Laboratories also maintains a high standard of animal welfare
compliance ascribing to the philosophy that good
animal welfare is good science.
Certifications of quality programs
Contract Research Services
(CRS):
GLP
GMP
ISO/IEC
17025
Research Models and Services (RMS):
ISO
9001:2000
Diet and
Bedding Monitoring
Health
Monitoring
Genetic
Monitoring
GLP
Harlan Laboratories has over 20 years of international
experience in implementation, realization, and performance of GLP
studies. Experienced in almost all kinds of study categories.
Familiar with authorities and mutual joint visit inspections.
Up-to-date regarding trends and changes within the GLP domain due
to regular meetings with the authorities. Active
memberships in international societies. All studies in
our European Contract Research Services division (CRS) are
performed according to the OECD GLP guidelines and the respective
national GLP laws.
CRS test facilities in Switzerland, Spain, Germany,
and the United Kingdom are regularly inspected
and certified by GLP compliance monitoring authorities. Official
inspections are undertaken in agreement with the OECD guidelines
for national GLP inspections and audits. Thanks to the
Mutual Acceptance of Data (MAD) established within the OECD,
all studies performed at these CRS test facilities are
accepted worldwide by the competent authorities. Field studies are
performed to comply with GLP and the standards laid down
in the Commission Directive 93/71 EEC for efficacy testing,
GEP.
GMP
Harlan Laboratories has over 10 years of experience operating
GMP-compliant laboratories within chemical and biological quality
control. Custom antibody production in the US and analysis of
pharmaceutical products at the CRS sites in Switzerland, Germany
and the United Kingdom are performed in compliance with local US
and European GMP regulations. A broad range of Pharmacopeia testing
can be conducted in accordance with regional requirements
(USP/BP/EP/JP).
ISO/IEC
17025
Over ten years of experience with testing
laboratories in the fields of food contact materials, medical
devices, toys, clinical biochemistry, in addition
to hematology, blood-coagulation and urine diagnostics,
veterinary clinical testing and testing of chemical disinfectants
and antiseptics.
ISO
9001:2000
Harlan Laboratories has developed and implemented a Quality
Management System designed to continually improve the effectiveness
and efficiency of the organization’s performance by considering the
needs of all interested parties (customers, shareholders,
suppliers, employees, and society). This program is implemented at
all US breeding and diet manufacturing sites and at
all equivalent European sites. The Quality Management System
complies with the ISO 9001:2000, international standard and its
technical equivalent ANSI/ISO/ASQ Q9001-2000.
Diet and Bedding
Monitoring
Teklad standard laboratory animal diets meet the highest
nutritional and hygiene standards. All diets are manufactured under
ISO 9000 procedures with careful ingredient sourcing and
monitoring. Many diets are offered certified for contaminant
analysis. High quality bedding and bedding enrichment products are
manufactured following appropriate quality standards and are
screened periodically for contaminants and can be certified on
request.
Health Monitoring
We are committed to providing the highest quality animals to the
research community and our health testing program provides you with
the assurance of that commitment. Our facilities are geographically
located near our customers to minimize transit time. We can ship to
meet your facility or institutional bioexclusion list and specific
health requirements. If any significant changes occur in colony
genetic, health or microbiologic status, customers are notified
immediately on confirmation. Animal colonies will be re-started to
eliminate significant pathogens or genetic contamination.
Microbiologically defined rodent and rabbit colonies are maintained
within maximum security production barriers and flexible-film
isolators. Colonies are monitored daily for clinical signs of
disease or abnormalities by trained personnel who are supported by
the veterinary medical staff. Our partnership with the Missouri
University Research Animal Diagnostic and Investigative Laboratory
(RADIL) ensures objective testing is performed using the latest
information on microbial pathogenicity and testing technology to
monitor the colonies for pathogenic and select opportunistic agents
by serology, PCR, nasopharyngeal and cecal culture, parasitology,
necropsy and histopathology.
North America Health Monitoring Program - click here
Europe/Israel Health Monitoring Program- based on FELASA
guidelines.
Genetic
Monitoring
The genetic integrity of all stocks and strains are maintained
through programs to prevent mismating, regular monitoring of animal
phenotype, and semiannual testing of inbred strains using Single
Nucleotide Polymorphisms (SNPs) as well as genetic monitoring of
mutant strains. Genetic testing is performed by the Harlan
GenScreenTM laboratory located at the Rutgers University
Bionomics Research and Technology Center (BRTC).
Europe Genetic Monitoring Program - click here
North America and Israel Genetic Monitoring Program - click
here