14/15 September 2021
Based on the CGMP requirements for single-entity and co-packaged combination products (21 CFR Part 4) the manufacturers of Oral Inhalation and Nasal Drug Products (OINDPs) have to be compliant with CGMPs for the drug constituent part(s) (21 CFR Parts 210 and 211) and the quality system (QS) regulations for device constituent part(s) (21 CFR Part 820).
This can be achieved either by a drug CGMP-based streamlined approach (21 CFR 4.4(a)) or a QS regulation-based streamlined approach (21 CFR 4.4(b)). Following the first approach the combination product manufacturers have to be compliant with the drug CGMP and device QS regulation requirements:
- 21 CFR 820.20 - Management responsibility
- 21 CFR 820.30 - Design controls
- 21 CFR 820.50 - Purchasing controls
- 21 CFR 820.100 - Corrective and preventive actions
- 21 CFR 820.170 - Installation
- 21 CFR 820.200 - Servicing
The OINDP manufacturers have to be clearly stated in their submission and at the initiation of a pre-approval inspection (PAI) whether they are operating under the drug CGMP or QS regulation-based approach.
Here you can see the complete FDA Draft Guidance on Combination Products including the requirements for Oral Inhalation and Nasal Drug Products.