What are the fundamental points to put in place when establishing your sub-contracting agreement with manufacturers, also called CMO (contract manufacturing organisation)?
The subcontractor is the private individual or legal entity that performs services on behalf of another organisation (the controller). The terms of the agreement must be clearly defined. Indeed, these beauty products are intended for oral or topical use and must not endanger the health of the consumer. Therefore, some key points need to be clarified before signing the sub-contracting agreement, with manufacturers.
CONCERNING THE PRODUCTION OF THE PRODUCTS
- Define precisely what is meant by “Product Production”.
- Provide a methodology, in case of product modifications or manufacturing processes
QUALITY CONTROL AND RELEASE OF PRODUCTS in the sub-contracting agreement
- Define who
- performs Quality Control and the parameters to be tested
- creates batch records and what they contain
- carries out the technical batch release, and on the basis of which criteria
- Define parameters for Acceptance / Rejection of batches?
- Batch Recall & Withdrawal Procedures
- a schedule of Quality Audits & Visits
- a vigilance system for the monitoring of marketed products, in order to systematically monitor possible adverse effects of products on human health. This activity is the responsibility of the manufacturers and distributors of the products.
Furthermore, it is essential to define the responsibilities of each party. What insurance is taken out?
In addition, the rights and duties in the event of the use of intellectual property rights must be defined.
And finally, we must not forget to clarify the rights about the non-transferability of the contract (all or part of it?).
Putting a place an agreement with a CMO must be carefully studied, and handle with a profesionnal.
Do not hesitate to contact us, if you wish to be accompanied, from R&D to the launch of your range of beauty products