FDA released draft guidance for cGMP requirements for Combination Products

FDA Released Draft Guidance for cGMP requirements for Combination Products codified as 21 CFR part 4. These draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on cGMP requirements for combination products. This guidance describes and explains the final rule on CGMP requirements for combination products that FDA issued on January 22, 2013. Prior to issuance of the final rule there were no regulations to clarify and explain the application of CGMP requirements to combination products.

The draft is divided into seven sections

I). Introduction

II). Background

III).General Considerations for CGMP Compliance

IV). what do I need to know about the CGMP requirements specified in 21 CFR 4.4(b)?

V). Application of CGMP requirements to specific types of combination products

VI). Contact Us

VII). References

The draft guidance was published in January 2015 for comment purpose. Comments and suggestions regarding this draft document can be submitted within 60 days of publication for public comment. You can view the full guidance Click here.