Comparability Protocols. Lore Fields MT(ASCP)SBB Consumer Safety Officer DBA/OBRR/CBER September 16, 2009. Agenda. Define Comparability Protocol (CP) When can a CP be used? CP Submissions Content of CP submissions Content of subsequent submissions Summary. Comparability Protocol (CP).
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Lore Fields MT(ASCP)SBB
Consumer Safety Officer
September 16, 2009
Described in 601.12(e)
An applicant may submit one or more protocols describing the specific tests and validation studies and acceptable limits to be achieved to demonstrate the lack of adverse effect for specified types of manufacturing changes on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Any such protocols, or change to a protocol, shall be submitted as a supplement requiring approval from FDA prior to distribution of the product which, if approved, may justify a reduced reporting category for the particular change because the use of the protocol for that type of change reduces the potential risk of an adverse effect.
Subsequent Submissions Content