Accreditations

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The studies performed at Specipig are conducted in compliance with the internationally accepted quality standards, following the guidelines issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), ISO 10993, US Food and Drug Administration (FDA) and other relevant health authorities. 

Specipig is an authorized breeding, supplier and animal experimentation centre since 2014 (B9900041). 

Our company has accredited by:

 

Good Laboratory Practice (GLP)

The term “GLP” or “Good Laboratory Practice” refers to a quality system that applies to non-clinical studies that assess the safety and efficacy of chemicals, medical devices and pharmaceuticals to be used on man, animals or in the environment. GLP comprises a set of quality standards that guarantee the uniformity, consistency, reliability, reproducibility, quality and integrity of chemical and pharmaceutical non-clinical safety tests. The GLP quality system was adopted by the Organization for Economic Co-operation and Development (OECD) in 1992.

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Quality Assurance Unit (QAU)

QAU takes care of the fulfilment of Domestic, EU and FDA guidelines and the Quality Policy of the company. The quality assurance system is submitted to periodical internal and external audits and reviews. Both through quality certification forms or by direct inspections in our facilities.

 

Openness on Animal Research

Specipig has joined the agreement on Openness on Animal Research promoted from the Federation of Scientific Societies in Spain (COSCE), with the collaboration of the European Association of Research Animals (EARA), and launched on 20 September 2016.

Animal experimentation plays a fundamental role in the discover of the underlying biological mechanisms of disease, and in the developing of medical treatments. Without research in animals, we would not have most of the medicines, antibiotics, vaccines and surgical techniques that are applied nowadays in human and veterinary medicine.

An important part of the research undertaken at Specipig aims at contributing to the improvement of human health and wellbeing and is carried out thanks to the use of animals, for example (name of research areas, laboratories, cancer, etc.).

The welfare of animals used for research purposes is of paramount relevance for Specipig, and also the strict compliance and respect to the current legislation on the protection of animals used in research and for other scientific purposes, including education. Our aim is to achieve the highest standards in animal welfare, not only from the point of view of our moral responsibility on them, but also because we are convinced we could not achieve research excellence without proper animal welfare. Our experiments with animals follow the legal standard and are assessed by an Ethics Committee on Animal Experimentation that promotes the use of alternative methods, the reduction in the number of animals used and the refinement in the experimental protocols applied. Not a single research project requiring the use of animals could start without the appropriate and required ethics assessment and the eventual authorization from the competent authorities. 

Specipig also ensures that the personnel involved in animal care and researchers do have the adequate education and training and the required professional skills, and that all resources are provided to properly keep research animals in terms of facilities, husbandry, wellbeing and veterinary care.

Specipig has been involved in the following initiatives towards the Openness on Animal Research (for example, appearances in mass media, popular science seminars, open-doors days, etc.).

 

AAALAC certification

The AAALAC International accreditation program evaluates organizations that use animals in research, teaching or testing. Through a voluntary accreditation programme it also promotes the humane treatment of animals used in research. Specipig is working to obtain the accreditation by 2021.