Comparability Protocols.ppt

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) What is a CP? 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. Comparability Protocol (CP) What is a CP? (cont) Submission option Highly specific, well-defined plan for implementing a change in manufacturing Demonstrate that change does not affect safety, identity, purity or potency Comparability Protocol (CP) What is a CP? (cont) Specific for the change and for the applicant FDA will approve CP if change does not adversely affect product Approval of CP may allow a reduced reporting category for future implementation of the specific change in the CP Expedite interstate distribution of products Not appropriate for all changes Comparability Protocol (CP) When can a CP used? Product manufactured using the change will meet approved product standards Manufacturing process has been validated and all equipment has been qualified Appropriate validated assays are available to detect effect of the change on the product Implementation of single change in multiple locations operating under the same license using SOPs, forms, labels, etc.