A colleague in Ohio wonders how others intend to comply in general with the upcoming cGTPs (21 CFR Parts 16, 1270, and 1271 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule), but in particular his primary concern is about cGTP 1271.210 (PDF file) page 74. He interprets 1271.210 to require each new lot of critical supplies to come with a certificate of analysis to document sterility. His institution currently qualifies their suppliers based on compliance with cGMPs, FDA registration/licensure, AABB and CAP accreditation, ISO certification, and if they have an active quality program, recall mechanism, etc. However, until now his institution has not asked for a certificate of analysis with each new lot number nor does his institution perform sterility testing on each new lot number prior to first use. Rather, his institution performs sterility studies after manipulation of the critical materials, such as after the addition of DMSO and these data are followed and reviewed in a quality program format.

ADDENDA Apr. 10, 2005

1. The Editor & Moderator wonders if other institutions interpret 21 CFR 1271.210 in a manner similar to the Ohio colleague's institution? If so, how will you comply? If not, what is your interpretation and plan for compliance?

ADDENDA Apr. 21, 2005

2. A colleague at an academic medical center in South Carolina reports that they routinely request a certificate of analysis for reagents/supplies that come into direct contact with HPC. They only require one certificate per lot.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator