GMP for Combination Products

QMN Weekly Bulletin wrote:

Proposed Rule for Combo Products Offers Streamlined GMP Option
Makers of components in co-packaged or single-entity combination products would have two options for showing compliance with quality system requirements for devices and cGMPs for drugs or biologics under a new proposed rule.

For co-packaged or single-entity combination products, the rule proposes that companies demonstrate compliance with all cGMP regulations for each part of the product. Alternatively, companies could develop written procedures for a "streamlined system," which could show compliance with the regulations for either devices or drugs plus certain provisions of the rules for the other component.

"What will be critical for industry to do is to document their revised manufacturing procedures to assure they are fulfilling the supplementary requirements and be able to provide objective evidence of compliance," Steven Niedelman, senior consultant with Crowell & Moring, said. Comments are due by Dec. 22.
The GMP Letter