Re: Design for Sterilization Companies - The design of sterilization validation progr
A sterilization company is in essence a contract manufacturing-service provider...not conceptually different from other contract manufacturers.
As such, a certain parallelism of definitions must exist.
Normally, a contract manufacturer is (by contract and by FDA definition) not responsible for the design of the product, per se...unless they also were contracted to provide product design services. A 13485/MDD analysis, I think, would generally be similar.
However, a contract manufacturer usually is responsible for the design of the process that they will use to manufacture whatever they were contracted to make.
This usually includes making engineering decisions as to how to successfully validate that process. The product's marketer usually has primary regulatory responsibility for the validation of the contract manufacturer's processes, to the extent that such validation is required...but usually it's the contract manufacturer that actually does that validation.
A sterilization company usually is responsible for the design of the process they use to accomplish sterilization. That process design is non-trivial, both practically and from a regulatory perspective. This usually includes making engineering decisions as to how to successfully validate that process.
Thus I'd think that design controls do apply.
Of course, that process design/engineering work might be concentrated at one or a few locations of a multi-location company.
In this instance, I'd think the company's current quality manual is incorrect.