Manufacturing medicinal and non-pharmaceutical Products on the same Equipment - is that possible?

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

To the question, whether it is possible to manufacture medicinal and non-pharmaceutical products on the same equipment, the FDA gives a clear answer in a current Warning Letter: No, this does not comply with CGMP.

As a consequence of manufacturing medicinal and non-pharmaceutical products on the same equipment, the FDA requests a risk assessment for all medicinal products manufactured on this equipment. The potential contamination from sharing the equipment is to be assessed. Further, plans are required to address product quality and patient risk for each product in distribution (including potential recalls and withdrawal of approval).

The FDA also required plans as to whether the company intends to continue manufacturing medicinal and non-pharmaceutical products. If both are to continue to be manufactured, the FDA wants to see plans showing that dedicated equipment will be used for the respective operations.

The cleaning validation programme should be improved in terms of "worst-case" conditions. Consideration should be given to:

• Medicinal products with higher toxicities 
• Medicinal products with higher active ingredient levels 
• Medicinal products with low solubility in the cleaning reagent 
• Medicinal products with properties that make them difficult to purify 
• Swab sampling sites to locations that are most difficult to clean 
• Standing time before cleaning

In addition, the FDA still requires the specification of the necessary steps to be taken in the change management system before a new manufacturing equipment or product can be introduced. Also requested is a CAPA plan based on retrospective review of cleaning operations with suggested improvements including timelines for implementation as well as a description of improvements to the cleaning programme, including improvements to cleaning effectiveness and ongoing cleaning verification.

You can find the entire Warning Letter addressed to System Kosmetik Produktionsgesellschaft für kosmetische Gmbh on the FDA website.