During the manufacture of investigational products, different products may be handled in the same premises and at the same time, and this reinforces the need to eliminate all risks of contamination, including cross-contamination. Special attention should be paid to line clearance in order to avoid mix-ups. Validated cleaning procedures should be followed to prevent cross-contamination.
For the production of the particular products referred to in section 11.20 of the guide on GMP (2, page 38), campaign working may be acceptable in place of dedicated and self-contained facilities. Because the toxicity of the materials may not be fully known, cleaning is of particular importance; account should be taken of the solubility of the product and excipients in various cleaning agents.