FDA Issues the Final Rule on GCP Requirements for Combination Products

FDA issues the final rule on CGP requirements for combination products.

This rule is similar to the draft rule issued by FDA a few years ago.

For certain classes of combination products, companies have the choice of complying with either all of the GMP requirements for both components (drug and device, or biological and device) or taking a streamlined approach whereby the company documents compliance with either the drug GMPs or the QS regulations along with demonstrating of compliance with specified provisions of the other of the two components.

For example, a drug/device combination product, where the drug uses a delivery system (device) to deliver the dosage, this combination product will need to comply with 21CFR Part 211 and the following sections of 21CFR part 820:

§ 820.20. Management responsibility
§ 820.30. Design controls
§ 820.50. Purchasing controls
§ 820.100. Corrective and preventive action
§ 820.170. Installation (if applicable)
§ 820.200. Servicing (if applicable)

The other example, a device/drug combination product, where the device is coated with a drug (stent with drug coating), this combination product will need to comply with 21CFR Part 820 and the following sections of 21CFR part 211:

§ 211.84. Testing and approval or rejection of components, drug product containers, and closures
§ 211.103. Calculation of yields
§ 211.132. Tamper-evident packaging requirements for over the-counter (OTC) human drug products
§ 211.137. Expiration dating
§ 211.165. Testing and release for distribution
§ 211.166. Stability testing
§ 211.167. Special testing requirement
§ 211.170. Reserve samples

Read the FDA guidance here.