Draft guidance published September 29, 2004

CGMP and QS regulations are similar but tailored to the product for which they were designed. Parallel GMP operating systems are not needed.

Each constituent part of a combination product is subject to its governing GMP regulations before combination.

During and after combination (21 CFR 3.2(e)(1) or (e)(2)), both regulations apply.

Compliance with both regulations can generally be achieved by using either regulation (e.g., by using the system in place at a facility)