Draft Guidance for Industry on Comparability Protocols for Drugs and Biologics: Chemistry, Manufacturing, and Controls Information
The FDA is announcing the availability of a draft guidance for industry entitled “Comparability Protocols for Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.” This document is a revised version of a draft guidance that published in February 2003.
This guidance provides recommendations to human drug and biologics manufacturers on implementing a chemistry, manufacturing, and controls (CMC) post approval change(s) through the use of a comparability protocol (CP). Submission of a CP in an original application or prior approval supplement (PAS) allows the agency to review a description of one or more proposed CMC postapproval changes, supporting information including any analysis and risk assessment activities, a plan to implement the change(s), and, if appropriate, a proposed reduced reporting category for the change(s). In many cases, using an approved CP will facilitate the subsequent implementation and reporting of CMC changes, which could result in moving a product into distribution or facilitating a proactive approach to reinforcing the drug supply chain sooner than if a protocol were not submitted.
This draft guidance articulates current regulatory concepts and is intended to establish a framework to promote continuous improvement in the manufacturing of quality drug products. The draft guidance also provides for less burdensome mechanisms to implement certain modifications to an already approved comparability protocol to make protocols more flexible and useful.
To read the draft guidance, visit our website:
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