5 Basics To Understand And Control The Supply Chain In Drug Manufacturing
Patient safety of medication starts with safe ingredients. The news of August 3rd 2018 was that the UMC hospital in Amsterdam was asked (ordered) by the Dutch Health Authority to stop administering the in-house prepared drug for CTX (a metabolic disease) (Dutch newspaper article: https://www.telegraaf.nl/nieuws/2388301/amsterdam-umc-roept-medicijn-stofwisselingsziekte-terug)
The Health Authority made the UMC stop using their drug because the Chinese API could not be tested completely and contained impurities. The UMC indicated that it was very disappointed since they had the drug tested by an accredited laboratory following EU regulation.
The only way?
The mistake the UMC apparently made, is to think that one can fully test an API. Both Health Authorities and Pharmaceutical Companies know that a fully controlled and understood supply chain, in combination with analysis, is the only way to ensure the quality of the API used in drug and with that: patient safety. That is the reason why pharmaceutical companies have a strict supply chain management programs and why Health Authorities, during inspections, focus on supply chain management and supplier auditing. The current trend is that the Health Authorities are moving more and more responsibility to the pharmaceutical company.
So, what should you at least do to understand and control your supply chain[1]:
- Know the name and location of the actual manufacturer (not just the broker)
- Also, know the brokers and their activities. If the brokers repackages, they may impact the product quality
- Audit the manufacturer and brokers using an experienced Quality Auditor, look at:
- The knowledge and consistency of the manufacturing process
- The reliability of the analytical results at the manufacturer
- The content and adherence to the various quality systems, including compliance to cGMP guidelines.
- Have a Quality Agreement in place with the actual manufacturer and brokers to define mutual responsibilities to ensure product quality and consistency
- Test the product using trustworthy laboratories following EU regulation
Do you need your supply chain to be transparent and controlled, e.g. through auditing of your suppliers and the creation of Quality Agreements: De Jong Pharma Consult (www.djpc.eu) is your solution.
If you wish to ensure your patients safety by controlling you supply chain, please contact me at info@localhost or call me at +31 6 18 49 39 56
[1] This is a basic overview, a full supply chain management program is more elaborate.