Bulletin 17-9

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FDA Issues Clarification of 21 CFR

§ 1271.210 Supplies and Reagents

Bulletin 17-9

September 18, 2017

In response to an inquiry from an accredited member organization, the U.S. Food and Drug Administration (FDA) provided the American Association of Tissue Banks (AATB) with a clarification of the requirements of Sec. 1271.210 about documentation on supplies and reagents applicable to recovery establishments working in partnership with processors.

Specifically, recovery organizations engaged in recovery operations under contract, agreement, or other arrangement for a processor, whereas specific supplies and/or reagents are provided or required by the processor, may either:

  1. Retain copies of specification sheets, Certificates of Analysis (COA), or manufacturer's package inserts describing the reagent and/or supply to verify suitability; or
  2. Ensure their contract, agreement, or other arrangement with the processor includes information that the supply and/or reagent has been verified.

If a recovery organization elects to use supplies and/or reagents that are not specifically required by the processor, or are not specified in the contract, agreement, or other written arrangement, the recovery organization should maintain records of the verification of such supplies or reagents.

If a processor requires that specific supplies and reagents be used by recovery establishments, then the processor should verify the supplies and reagents and should include this information in its contracts, agreements, or other arrangements with the recovery establishment.

In addition, FDA recommends that product information data sheets for all used supplies and reagents are preserved, updated as products change, and kept in an archive of previously used products. Verification that reagents meet specifications may be accomplished either by reviewing the Certificate of Analysis (COA) or by performing relevant testing. Records of the verification of each supply or reagent, including test results or, in the case of vendor verification, a COA from the vendor, must be kept by the responsible tissue establishment in a ccordance with 1271.210(d)(2).

If supplies and/or reagents are received from a vendor or another establishment, the receiving tissue establishment should verify that the vendor or other establishment has a system in place to certify that the supplies and/or reagents meet established specifications. The receiving tissue establishment could reference specification sheets, COAs, and manufacturer's package inserts describing the reagent and/or supply to verify suitability.

In the Current Good Tissue Practice Guidance, FDA further explains that a tissue establishment or a vendor must verify that those supplies and reagents used in all steps of the manufacture of HCT/Ps (not only those that come in contact with HCT/Ps), including recovery, meet specifications designed to prevent circumstances that increase the risk of introduction, transmission, or spread of communicable diseases. Under § 1271.210(a), a tissue establishment must not use supplies and reagents until they have been verified to meet specifications designed to prevent circumstances that increase the risk of the introduction, transmission, or spread of communicable diseases. Verification may be accomplished by the establishment that uses the supply or reagent, or by the vendor of the supply or reagent.