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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Food and Drug Administration, HHS

§ 1271.270

to be ineligible or for whom a donoreligibility determination has not been
completed (except as provided under
§§ 1271.60, 1271.65, and 1271.90), or that
otherwise does not meet release criteria designed to prevent communicable disease transmission.
(3) You must not make available for
distribution any HCT/P manufactured
under a departure from a procedure relevant to preventing risks of communicable disease transmission, unless a
responsible person has determined that
the departure does not increase the
risk of communicable disease through
the use of the HCT/P. You must record
and justify any departure from a procedure at the time of its occurrence.
(d) Packaging and shipping. Packaging
and shipping containers must be designed and constructed to protect the
HCT/P from contamination. For each
type of HCT/P, you must establish appropriate shipping conditions to be
maintained during transit.
(e) Procedures. You must establish
and maintain procedures, including release criteria, for the activities in
paragraphs (a) through (d) of this section. You must document these activities. Documentation must include:
(1) Identification of the HCT/P and
the establishment that supplied the
HCT/P;
(2) Activities performed and the results of each activity;
(3) Date(s) of activity;
(4) Quantity of HCT/P subject to the
activity; and
(5) Disposition of the HCT/P (e.g.,
identity of consignee).
(f) Return to inventory. You must establish and maintain procedures to determine if an HCT/P that is returned to
your establishment is suitable to be returned to inventory.
§ 1271.270 Records.
(a) General. You must maintain
records concurrently with the performance of each step required in this subpart and subpart C of this part. Any requirement in this part that an action
be documented involves the creation of
a record, which is subject to the requirements of this section. All records
must be accurate, indelible, and legible. The records must identify the person performing the work and the dates

of the various entries, and must be as
detailed as necessary to provide a complete history of the work performed
and to relate the records to the particular HCT/P involved.
(b) Records management system. You
must establish and maintain a records
management system relating to core
CGTP requirements. Under this system, records pertaining to a particular
HCT/P must be maintained in such a
way as to facilitate review of the HCT/
Ps history before making it available
for distribution and, if necessary, subsequent to the HCT/Ps release as part
of a followup evaluation or investigation. Records pertinent to the manufacture of HCT/Ps (e.g., labeling and
packaging procedures, and equipment
logs) must also be maintained and organized under the records management
system. If records are maintained in
more than one location, then the
records management system must be
designed to ensure prompt identification, location, and retrieval of all
records.
(c) Methods of retention. You may
maintain records required under this
subpart electronically, as original
paper records, or as true copies such as
photocopies, microfiche, or microfilm.
Equipment that is necessary to make
the records available and legible, such
as computer and reader equipment,
must be readily available. Records
stored in electronic systems must be
backed up.
(d) Length of retention. You must retain all records for 10 years after their
creation, unless stated otherwise in
this part. However, you must retain
the records pertaining to a particular
HCT/P at least 10 years after the date
of its administration, or if the date of
administration is not known, then at
least 10 years after the date of the
HCT/Ps distribution, disposition, or expiration, whichever is latest. You must
retain records for archived specimens
of dura mater for 10 years after the appropriate disposition of the specimens.
(e) Contracts and agreements. You
must maintain the name and address
and a list of the responsibilities of any
establishment that performs a manufacturing step for you. This information must be available during an inspection conducted under § 1271.400.

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