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How Kemiex reviews and monitors Quality Compliance

Kemiex designed and established an evaluation and verification onboarding and monitoring procedure to ensure that only reliable and qualified companies are part of the platform, represented as a 5* Kemiex Quality Rating for each company in the platform.

A Quality questionnaire is filled-in by new platform members, asking them to provide information such as:

Does your company….
* …maintain a Quality Management System (QMS)?
* …have a QMS standard certification? (i.e. GMP, GMP+, FAMI-QS, HACCP, ISO, etc.)
* …hold a current dealer’s license, manufacturer’s license or equivalent license?
* …consider the rules of Good Distribution and Transportation Practice (GDP)?
* …document and guarantee the traceability of products back to the original manufacturer?
* …have a procedure for supplier qualification including contract manufacturers?
* …have a recall procedure in place?
* …have a procedure for handling of complaints?
* …have a warehouse to store or process goods?

Kemiex Quality Department, lead by Dr. André Rieks*, verifies all information, licenses and certificates, ensuring that only reliable and quality-compliant players are accepted to the platform. Approved information is directly made available inside the platform, supporting the trade process of Kemiex members.

For every transaction, additional documentation required by the purchaser is also exchanged inside the platform, such as: COA, GMP, GMP+, FAMIqs, Kosher, Halal, etc.

  • At the end of every transaction, Kemiex requests to both counterparties feedback such as:
  • Was the product delivered on time and in good conditions?
  • Was agreed documentation provided completely and in time?
  • Did the delivered product fulfill specification requirements according to agreed standards?
  • Has transportation been in compliance with GDP Guidelines (e.g. uninterrupted cool chain)?
  • In case of complaints, were they solved immediately and completely?

In case you would like to know more, you can leave us your details here and a member of our team will get in contact with you as soon as possible.

* DR. ANDRÉ RIEKS: André has over 16 years of experience in R&D and industrialization of several biotechnological products. He is a senior project manager and quality consultant specializing in APIs, Biopharmaceuticals and Fine Chemicals. Additionally, André is a certified Qualified Person and APIC Auditor according to ICH Q7. He holds a PhD in Biotechnology from the Technical University of Hamburg-Harburg.