Work Item
ASTM WK82752
New Practice for cGMP Best Practices for Combined Use Systems (medicinal product-device)
1. Scope
Combined use medical products inherently raise distinct/additional questions that need to be considered and may lead to a range of risk management/regulatory approaches based on where the product/use sits along a continuum of risk. There is a need to consider more than one medical product in risk analysis and control strategy, and the requirements imposed on the respective constituent parts and the overall product should be based on the scientific and technological considerations raised by the intended combined use of the medical products. This is the case, regardless of whether a given jurisdiction considers such product to be a “combination product,” medicinal product, or medical device, or any other such nomenclature (refer to ASTM Combination Product Standard Terminology). The intent of this standard is to establish harmonized cGMP best practices (perhaps harmonized expectations?) for such combined use systems, to be applied globally.
Keywords
combination products; combo products; GMP; Good manufacturing practices
Rationale
Among benefits, this harmonization could support mutual recognition approaches for submissions, inspections, and post market lifecycle management, promoting safety, efficacy and usability of these products for the patients we serve. Currently there is no such global standard for combination product cGMP expectations.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 07-14-2022
Technical Contact: Susan Neadle
Item: 000
Ballot:
Status: