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Posted 31 May 2013 | By Alexander Gaffney, RAC,
A new draft guidance document released by the US Food and Drug Administration (FDA) regarding making approved human blood and blood components lays out the agency's recommendations on which changes to a product or its manufacturing processes will require notifications to be made to the agency, and how to do so in a least-burdensome manner.
The guidance, released 31 May 2013, is specifically intended for manufacturers of licensed whole blood and blood component products (such as source plasma) intended for either transfusion or further manufacture. Such products are regulated under 21 CFR 601 (applications) and 21 CFR 1271 (quality), but the guidance is only concerned with the former of these, which includes considerations about comparability protocols and labeling changes at 21. CFR 601.12 (e) and (f).
FDA notes that manufacturers frequently request to make changes to their approved products, including the process by which they are made, the quality controls used in production and processing, the equipment used in manufacture, the facilities where they are manufactured, and the labeling affixed to the products. Requests for those changes may be made in one of three ways, depending on the scope of the change:
The guidance goes on to explain the exact requirements of submitting each of these changes. For example, a Prior Approval Supplement (PAS) under 21 CFR 601.12(b) will require a detailed description of the change, the products involved, the manufacturing site or areas affected, a description of the methods used and studies performance to evaluate the change, the data from performed studies, and a reference list of validation protocols and standard operation procedures.
But what is a major change that would require a PAS?
Changes Being Effected (CBE) documents require notification for the following, according to FDA:
FDA said it advises companies to specify that the changes are being reported as "CBE," and that it will determine if the change has been reported properly. "You do not have to wait for our written approval before distributing a product made using a change in this category," FDA added. However, companies should have tracking tools in place to make sure the products are held for the appropriate amount of time.
All other changes should be made in an annual report, such as changes that are more restrictive than the status quo.
Companies should expect to be able to prove the impact of all changes using a comparability protocol (CP) under 21 CFR 601.12(e), and FDA's guidance devotes an extensive amount of information to the exact circumstances under which one is required and the variable nature of the CP relative to each submission type (PAS, CBE and AR).
Comments on the guidance are due by 29 August 2013.
FDA: Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
Tags: Blood Products, Changes, draft guidance