Injectable Products Allowable Content WG

Sponsored by the Biologics CMC LG

PROBLEM STATEMENT 

FDA MAPP 5019.1 Rev. 1 was issued by CDER in 2022 addressing allowable excess volume/content in injectable drug and biological products, regarding a 2015 guidance but adding additional requirements. The implementation of this MAPP requires the establishment of a gross content specification for liquid and solid injectable products when presented in a vial. The recommended limits for this specification have potential implications on fill volume, assay/protein concentration, and misalignment with expectations from other regulatory agencies.

MISSION/OBJECTIVES

Mission:

1. Map out alternative strategies to comply with the new excess content requirements in MAPP 5019.1 in alignment with expectations from global regulatory authorities.
2. Collaborate with the FDA on the interpretation and implementation of MAPP 5019.1 Rev 1 via direct engagement and/or a position paper.

Objectives:

The WG will focus on the requirements outlined within the MAPP without comment on the process of issuance. The WG will seek to resolve areas of confusion, propose a best-practice interpretation ensuring safety in dosing, and advocate for alignment with global expectations regarding routine control strategy. An aspect of the problem statement that is beyond the scope of the working group is the establishment by the FDA of additional requirements via issuance of a MAPP for which there was no opportunity for public input before implementation. 

DESIRED IMPACT 

Derive industry consensus on strategies to address the new excess content requirements in MAPP 5019.1 Rev 1 and bridge the gap between the industry perspectives and the FDA expectations. This will have a significant impact on the development and control strategies of existing and new injectable vialed products in all phases of the product life cycle.