Harlan Laboratories uses cookies to provide users with region appropriate content and site navigation.
No personal identification data is collected and Harlan does not track individual users.
If you would like to disable cookies for this site, please click the disable button.
If you do not want to receive this message again in future visits to this site, or you accept the downloading of our cookies to your computer, please click the enable button.

Enable Cookies Disable Cookies

Quality Programs

Harlan Laboratories is unique among suppliers of research models and contract research services in the breadth of our quality programs.  These programs include ISO 9001:2008, 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 9001:2008   
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 9001:2008

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 diet manufacturing sites and at all animal breeding and equivalent European sites. The Quality Management System complies with the ISO 9001:2008 international standards and its technical equivalent.

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.

Health 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.

In our European Harlan Laboratories, all samples are identified by a unique bar code number.  All Labs perform nasopharyngeal and cecal culture, parasitology and necropsy, while serology and PCR is performed in our UK Lab using quality reagents and procedures.  The European laoratories regularly have results confirmed by external laboratories and participate in ring studies involving facilities across Europe and the US.

In the US, we have partnered with the Missouri Research Animal Diagnostic and Investigative Laboratory (RADIL) to provide state-of-the art, reliable and objective testing from a leader in laboratory diagnostic testing.

North America Health Monitoring Program - click here
Europe/Israel Health Monitoring Program- based on FELASA guidelines - click here
 

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).

North America and Israel Genetic Monitoring Program - click here
Europe Genetic Monitoring Program - click here

 

 

To contact a specialist, select your region