Compliance

Our products meet the highest ethical and legal standards. We comply with European biomedical conventions, respecting human rights and donor privacy. And we’re committed to quality, whether that’s in our products, or the training and customer service that support them.

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 400 human cell culture products including primary cells, stem cells, blood cells, and optimized cell growth and differentiation media. 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

ISO9001 Logo

Our ISO certification demonstrate our commitment to quality.

PromoCell operates according to ISO 9001:2015 in order to consistently provide products and services that meet customer requirements as well as applicable statutory and regulatory requirements.

Download certificate:

 

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.Logo EXCiPACT

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).

Download certificates:

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:

If you have any questions about the quality and ethical standards of our products, please get in touch.
approved-tissue-donor-program-promocell

Contact person:

Dr. Annemarie Aue
Phone: +49 6221 – 649 34 0
Fax:       +49 6221 – 649 34 40
ethics@promocell.com

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