Continuous Manufacturing does not Present Regulatory Hurdles, FDA Experts Say

The regulatory definitions of “batch” and “lot” do not present hurdles for implementing continuous manufacturing, FDA is stressing in highlighting the potential the new processing approaches offer to advance the objectives of its 21st Century quality initiative.

The adaptability of the batch/lot concerns in the GMPs to continuous manufacturing (CM) has been addressed in key presentations given at recent public forums by Center for Drug Evaluation and Research (CDER) officials Christine Moore and Francis Godwin.

Moore is Science and Policy Deputy Director for the Office of New Drug Quality Assessment (ONDQA) and Godwin is in the Division of Manufacturing and Product Quality (DMPQ) within CDER’s Office of Compliance. Both having strong engineering and operations experience in industry, the two agency officials are making a substantial contribution to the industry/regulator dialogue on how to drive forward the new pharmaceutical manufacturing and control approaches.

In addressing “regulatory perspectives on continuous manufacturing” at a session of the American Association of Pharmaceutical Scientists (AAPS) annual meeting in New Orleans in November, Moore recognized that people are confused by how CM can be reconciled with the frequent occurrence of the term “batch” in the CGMPs.

However, an assessment of the GMP batch and lot definitions shows they are not in conflict, she explained.

[More on the batch/lot and other regulatory considerations for continuous manufacturing, along with Moore’s full presentation, are provided for subscribers here.  Also see the IPQ “In the News” March 5 companion story covering Francis Godwin’s presentation at ISPE on key quality system considerations in continuous manufacturing. Non-subscribers can purchase the stories for $195 each by contacting Karen Bertani ( For subscription/license information click here.]