Sec. 252.110 Volume Limits for Automated Collection of Source Plasma

INTRODUCTION:

This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG and will be included in the next printing of the Compliance Policy Guides Manual. It is intended for FDA personnel and is available electronically to the public. This guidance document represents the agency's current thinking on the volume limits for automated collection of Source Plasma. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulation, or both.

BACKGROUND:

The Center for Biologics Evaluation and Research (CBER) issued a memorandum to all registered blood and plasma establishments on November 4, 1992 that addressed automation of the collection process for Source Plasma. Automation has led to an increase in FDA-approved nomograms, which specify, for each piece of equipment, the maximum volume of plasma to be harvested from each donor category. These devices vary in their capacity to tailor each collection to the specific donor. Because multiple types of equipment commonly coexist in any one location, the potential for error due to application of an inappropriate nomogram is significantly increased. The use of various anticoagulant solutions, differing concentrations of anticoagulant, and a range of anticoagulant to plasma ratios additionally complicate some schema and creates additional opportunity for error. Errors in the application of nomograms could result in overbleeding donors. The memorandum provided an alternative nomogram to the Source Plasma industry relative to the volume of plasma allowed to be collected using automated devices.

POLICY:

CBER developed the following simplified nomogram for those establishments that desired one uniform set of standards. The anticoagulant commonly used is a 4% Sodium Citrate solution administered at a rate, which will yield a 1:16 (0.06) ratio of anticoagulant to anticoagulated blood. The anticoagulated volume is included in the third column below.

If an establishment is approved to use a different anticoagulant, the volume of anticoagulant would need to be adjusted as documented in their license application.

Establishments may use this nomogram as written without amendment to their license. It also is still acceptable to use the limits established by the equipment manufacturer. However, the simplified nomogram and the manufacturer's nomogram should not be used simultaneously in the same center. Portions of this simplified nomogram should not be selectively applied in combination with some other system of limits. If an establishment wishes to use a modified version of this nomogram, it must submit a supplement to its license for approval prior to distribution of product made using the modification.

REGULATORY ACTION GUIDANCE:

Regulatory action may be considered if the firm is deviating from the policy stated above and from the conditions of its license.

For further guidance on deviations that result in donors being overbled, see Attachment A of Compliance Program 7342.002, Inspection of Source Plasma Establishments and Sec. 252.100 of the Compliance Policy Guide Manual, Source Plasma - Regulatory Action Based on Overbleeding. Firms may be cited under 21 CFR 640.65 if the nomogram used in a facility results in donors being overbled. CBER's Office of Compliance and Biologics Quality, HFM-610, also may be consulted for additional assistance in determining an appropriate course of action.

Issued: 3/6/2000