Cleaning Validation using artificial lead substances

Hi all,

I would be happy to receive as much feedback as possible on the following question to get a representative statement:

Our approach is that part of our worst-case products are artificial lead products, i.e. we use the basic formulation of a commercial product (matrix) that is critical for cleaning and we add a correspondingly high amount of a critical active ingredient (solubility).

The manufacturing process of this lead product is designed in such a way that it guarantees maximum accessibility of production equipment and the corresponding cleaning processes in production.
With a small number of key products and corresponding analytical methods, we can thus validate a very large number of cleaning processes and regularly check the efficiency and reproducibility of the cleaning processes specifically with the worst-case product.

The manufacturing process is qualified with regard to critical factors which could lead to an inhomogenous distribution of residues on the product contact surfaces (“validation light”).

According to chap. 10.1 of Annex 15 EU GMP guiodeline, such a procedure is permitted, provided that it is scientifically justified. We have had no problems in inspections with this approach so far.

Depending on the production planning and the complexity of the process chains, I believe that the advantages of such an approach outweigh the use of commercial products.

We manufacture liquid (solutions, suspensions) and semi-solid (gels, ointments) forms for use on the eye.

I would be interested in the following:

Is anyone else using the approach with artificial lead products?

If not,

  • do you have guidelines (e.g. global policies) that explicitly mention and exclude such a procedure?

  • from your point of view or with your experience / expertise, what could be the reason for not using artificials?

If yes,

  • do you have guidelines (e.g. global policies) that explicitly mention and allow such a procedure?

  • what experience do you have in this regard with your local authority, international authorities, customers?

It would be helpful if you could add the following information:

  • size of your company (globally or nationally operating, medium to small size, etc.)

  • dosage forms (solid, semi-solid, liquid forms)

  • Field of application of your products

  • number of worst-case products (key substances), cleaning processes

Looking forward to your answers!
Thank you very much.


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