Our commitment to quality
To do great research, you need high-quality products you can trust. That’s why we’ve put quality and reliability at the heart of our business for over 30 years.
Our portfolio includes over 7,000 cell culture and cell biology products. Each is rigorously tested, and designed to meet the demands of cutting edge research.
This commitment to quality extends to our service. We see our customers as partners, and we want to give them the support they need to do groundbreaking work – whether that’s everyday customer support, detailed technical help, or training that empowers them to do more.
For us, quality is never optional.
Quality Policy
Our quality policy is underpinned by four key premises:
- Provide high-quality reliable products
- Maintain a high ethical standard
- Support customized requirements
- Continuous improvement & development
To learn more, download our Quality Policy Statement
ISO 9001:2015 certification
Our ISO certifications demonstrate our commitment to quality.
ISO 9001:2015 certification ensures that we “consistently provide products and services that meet customer and applicable statutory and regulatory requirements”.
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EXCiPACT™ GMP Certification
Our Quality Management System is also certified according the EXCIPACT™ GMP standard.This certification also covers the GMP requirements according to NSF/IPEC/ANSI 363.
We produce our cell culture media and reagents using the highest standard of raw materials to ensure their quality when used as pharmaceutical excipients. They are manufactured in adherence to GMP standards as published by IPEC (International Pharmaceutical Excipients Council) in the Joint Good Manufacturing Practice Guide for Pharmaceutical Excipients.
Good Manufacturing Practice (GMP) refers to guidelines for quality assurance of production processes and environment in the manufacturing of pharmaceuticals and active ingredients, but also in cosmetics, food and feed. Quality assurance plays a central role in pharmaceutical manufacturing, as quality deviations can have a direct impact on the health of consumers. A GMP-compliant quality management system serves to ensure product quality and to meet the requirements of health authorities.
PromoCell manufactures a range of cell media and reagents at the facility located in Heidelberg. As cell culture media cannot be used as active pharmaceutical ingredients (API), media have to be classified as pharmaceutical excipients or pharmaceutical auxillary material based on the final application at the user site. Regulators require excipient suppliers to qualify their manufacturing processes based on GMP audits and it is noted that third party auditing of suppliers, i.e. performed by the registered EXCiPACT Certification Body, is acceptable (Directive 2011/62/EU, 8 June 2011).
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Ethical standards
All our products meet the strictest European and international ethical standards.
We comply with the following best-practice procedure for human tissue donation and collection:
The tissue used by PromoCell for the isolation of human cell cultures is derived from donors who have signed an informed consent form (this being done by the donor himself, an authorized agent, or a legal agent) which outlines in detail the purpose of the donation and the procedure for processing the tissue. We do not accept or use any tissue without prior signing of the consent documents.
Our procedure always meets these international standards:
- “The Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention of Human Rights and Biomedicine” published on April 4th, 1997 by the Council of Europe (European Treaty Series – no 164).
- “The Human Tissue Act” published on November 15th, 2004 by the government of the United Kingdom. This act aims to make consent a fundamental principle underpinning the use and storage of human tissue. More about PromoCell Cells and HTA.
- “The Declaration of Helsinki” developed by the World Medical Association as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.
- “German Federal Data Protection Act“ and “General Data Protection Regulation” to protect privacy of donors.
If you have any questions about the quality and ethical standards of our products, please get in touch.
Contact person:
Dr. Annemarie Aue
Phone: +49 6221 – 649 34 0
Fax: +49 6221 – 649 34 40
ethics@promocell.com