Process Validation in Homeopathic Manufacturing - FDA's Perspective

In a current Warning Letter, the FDA describes the process validation requirements imposed on a contract manufacturer of homeopathic medicinal products.

In the course of an FDA inspection, the investigator discovered that the content of a homeopathic drug did not correspond to the declaration. There was no process validation. In order for the company to be allowed to export to the USA again, the FDA expects, among other things, the following: 

  • A detailed summary of the validation plan, which covers the product life cycle, with the corresponding individual procedures.
  • A description of the Process Performance Qualification (PPQ) programme and how the monitoring is to be carried out according to the PPQ and Continued/Ongoing Process Verification with regard to intra-batch and inter-batch variabilities.
  • A timeline for when the PPQ for each medicinal product should take place.
  • A programme for the qualification of equipment and premises.
  • An evaluation of each manufacturing process that ensures that a data-based, scientifically based programme identifies and controls the causes of variability.

Other points of criticism by the FDA were the inadequate testing of starting materials (21 CFR 211.84) and the inadequate functioning of the Quality Control Unit (21 CFR 211.22). Referring to 21 CFR 211.34, the FDA recommends engaging a GMP consultant. Finally, the FDA explains to the contractor that contractors are seen as "extended arm" of the external manufacturer and that they therefore remain responsible for the product.
You can find the Warning Letter on the FDA website.

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