21cfr1271

§ 1271.250

21 CFR Ch. I (4–1–06 Edition)

and tests, you must validate and approve the process according to established procedures. The validation activities and results must be documented, including the date and signature of the individual(s) approving the
validation.
(b) Written representation. Any written representation that your processing methods reduce the risk of
transmission of communicable disease
by an HCT/P, including but not limited
to, a representation of sterility or
pathogen inactivation of an HCT/P,
must be based on a fully verified or
validated process.
(c) Changes. When changes to a validated process subject to paragraph (a)
of this section occur, you must review
and evaluate the process and perform
revalidation where appropriate. You
must document these activities.

(1) HCT/P type;
(2) Processing, including the method
of preservation;
(3) Storage conditions; and
(4) Packaging.
(d) Corrective action. You must take
and document corrective action whenever proper storage conditions are not
met.
(e) Acceptable temperature limits. You
must establish acceptable temperature
limits for storage of HCT/Ps at each
step of the manufacturing process to
inhibit the growth of infectious agents.
You must maintain and record storage
temperatures for HCT/Ps. You must periodically review recorded temperatures to ensure that temperatures have
been within acceptable limits.

§ 1271.250 Labeling controls.
(a) General. You must establish and
maintain procedures to control the labeling of HCT/Ps. You must design
these procedures to ensure proper HCT/
P identification and to prevent mixups.
(b) Verification. Procedures must include verification of label accuracy,
legibility, and integrity.
(c) Labeling requirements. Procedures
must ensure that each HCT/P is labeled
in accordance with all applicable labeling requirements, including those in
§§ 1271.55,
1271.60,
1271.65,
1271.90,
1271.290, and 1271.370, and that each
HCT/P made available for distribution
is accompanied by documentation of
the donor eligibility determination as
required under § 1271.55.

(a) Receipt. You must evaluate each
incoming HCT/P for the presence and
significance of microorganisms and inspect for damage and contamination.
You must determine whether to accept,
reject, or place in quarantine each incoming HCT/P, based upon pre-established criteria designed to prevent
communicable disease transmission.
(b) Predistribution shipment. If you
ship an HCT/P within your establishment or between establishments (e.g.,
procurer to processor) and the HCT/P is
not available for distribution as described in paragraph (c) of this section,
you must first determine and document whether pre-established criteria
designed to prevent communicable disease transmission have been met, and
you must ship the HCT/P in quarantine.
(c) Availability for distribution. (1) Before making an HCT/P available for
distribution, you must review manufacturing and tracking records pertaining to the HCT/P, and, on the basis
of that record review, you must verify
and document that the release criteria
have been met. A responsible person
must document and date the determination that an HCT/P is available
for distribution.
(2) You must not make available for
distribution an HCT/P that is in quarantine, is contaminated, is recovered
from a donor who has been determined

§ 1271.260 Storage.
(a) Control of storage areas. You must
control your storage areas and stock
rooms to prevent:
(1) Mix-ups, contamination, and
cross-contamination of HCT/Ps, supplies, and reagents, and
(2) An HCT/P from being improperly
made available for distribution.
(b) Temperature. You must store HCT/
Ps at an appropriate temperature.
(c) Expiration date. Where appropriate, you must assign an expiration
date to each HCT/P based on the following factors:

§ 1271.265 Receipt,
predistribution
shipment, and distribution of an
HCT/P.

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