PromoCell's New GMP Certification - EXCiPACT

insights from industryDr. Irma Börcsök and Dörte Keimer CEO and Head of Quality AssurancePromoCell

In this interview, News-Medical talks to Dr. Irma Börcsök (CEO of PromoCell) and Dörte Keimer (Head of Quality Assurance) about PromoCell, the work they do, and the latest GMP certification the company has achieved - EXCiPACT.

Could you provide a brief overview of PromoCell and the work you do?

PromoCell has supported scientists worldwide in the field of biomedical research and industry research applications for over 30 years.

Today, PromoCell is widely regarded for its high level of competence, as well as its work with a wide range of primary human cells, stem cells, blood cells, and technically advanced cell culture media. Our certified cell culture media and reagents are available to our customers as pharmaceutical excipients on request.

What exactly is the EXCiPACT GMP certification and how is it complementary with the ISO 9001:2015?

Pharmaceutical excipient production should be carried out in accordance with the principles defined in the Good Manufacturing Practices (GMP). With that in mind, a group of industry experts including EFCG, IPEC and PQG worked together to develop the EXCiPACT certification scheme for pharmaceutical excipient suppliers.

ISO 9001 forms the basis for the EXCiPACT GMP standard, which is an annex to ISO 9001:2015. The US National Standard “Good Manufacturing Practices (GMP) for Pharmaceutical Excipients NSF/IPEC/ANSI 363-2016” also provides guidance and additional requirements,

PromoCell is certified to meet all of these requirements.

Following on from the previous question, could you please explain the importance of this certification to PromoCell?

Regulatory authorities require that pharmaceutical companies’ suppliers are qualified using standard GMP audits. This audit can be completed in-house, or by a third party such as an independent certification body.

EXCiPACT is a non-profit organization that oversees and operates one such independent, high-quality third-party certification system. This certification system is available to pharmaceutical manufacturers and distributors around the world.

PromoCell can share both the certificate and the audit report with customers, providing them with documentation that both the customer and their local authority can use to risk assess our products. This reduces the burden of audits on both sides.

What did PromoCell need to demonstrate in order to be approved for the EXCiPACT GMP certification?

To achieve EXCiPACT GMP certification, PromoCell was required to demonstrate that its pharmaceutical excipients are manufactured according to the GMP guidelines, as well as ensuring compliance in our raw material supply chain, production environment, production processes and storage conditions.

The company had to provide a range of documents, including batch records and corresponding certificates confirming identity and traceability.

How will the certification affect how PromoCell operates?

PromoCell had already implemented the ISO 9001 quality management system in 2012, holding an ISO 9001:2015 certification, maintaining high quality standards and centralizing continuous improvement in our work.

As part of our work to achieve EXCiPACT GMP certification, we have introduced a new customer requirement document process (CRD). Customers working in regulated environments can use the CRD to identify, determine and communicate their regulatory requirements to us. This process is highly beneficial for our customers, because it allows us to customize products and documentation according to their needs.

Are there any products in particular that the EXCIPACT GMP certification will be important for?

EXCiPACT GMP certification covers the production of our entire cell culture media and reagents portfolio, meaning that all of these products can be implemented as part of our CRD process.

We are experiencing a growing demand for products designed for stem cell and cancer cell research applications; so in recent years PromoCell has developed a range of advanced cell culture media that can be provided as either xeno-free or chemically defined.

What does the future hold for PromoCell?

EXCiPACT GMP certification allows us to better accommodate the growing demand for products suitable for use in a regulated environment. Thanks to this certification, PromoCell will make important contributions in the transition from research to application.

About the interviewees

Dr. Irma Börcsök received her PhD degree in Biology from the University of Heidelberg (Germany), focusing on studying osteonecrotic bone metabolism in a primary human cell culture model. Irma was initially Production Director at PromoCell before shifting into the position of COO where she was responsible for the production of PromoCell’s cell culture and media portfolio as well leading R&D with her strong scientific background. Now she brings her 20 years’ experience into the CEO role.

Dörte Keimer has a strong background in GMP cell culture. She received her Master degree at the University of Krems (Austria) in Clinical Research and worked for eleven years in a variety of levels - but last as Head of Production according to EU GMP Guidelines manufacturing Advanced Therapy Medicinal Products (ATMPs). Dörte joined PromoCell in 2013 initially as Head of Quality Control. As Head of Quality Assurance she now leads also the Regulatory Affairs unit focusing on the customized documentation for PromoCell’s cell culture media and reagents used as pharmaceutical excipients.

About PromoCell

Advances in science and medicine are powered by human endeavor. PromoCell empowers your biomedical research. We are your partners for primary cells and cell culture media, as well as for cell biology research. Our portfolio comprises more than 7,000 products that follow the strictest ethical and quality standards.

With more than 30 years of experience in human primary cell culture, we deliver research tools for scientists worldwide. Because sharing knowledge is key to scientific discovery, we also offer professional training at our PromoCell Academy. Our team of experts is by your side in your quest for new therapies.

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