21cfr1271

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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