21cfr1271

Food and Drug Administration, HHS

§ 1271.230

must display records of recent maintenance, cleaning, sanitizing, calibration, and other activities on or near
each piece of equipment, or make the
records readily available to the individuals responsible for performing
these activities and to the personnel
using the equipment. You must maintain records of the use of each piece of
equipment, including the identification
of each HCT/P manufactured with that
equipment.
§ 1271.210

Supplies and reagents.

(a) Verification. You 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.
(b) Reagents. Reagents used in processing and preservation of HCT/Ps
must be sterile, where appropriate.
(c) In-house reagents. You must validate and/or verify the processes used
for production of in-house reagents.
(d) Records. You must maintain the
following records pertaining to supplies
and reagents:
(1) Records of the receipt of each supply or reagent, including the type,
quantity, manufacturer, lot number,
date of receipt, and expiration date;
(2) Records of the verification of each
supply or reagent, including test results or, in the case of vendor
verification, a certificate of analysis
from the vendor; and
(3) Records of the lot of supply or reagent used in the manufacture of each
HCT/P.
§ 1271.215

Recovery.

If you are an establishment that recovers HCT/Ps, you must recover each
HCT/P in a way that does not cause
contamination or cross-contamination
during recovery, or otherwise increase
the risk of the introduction, transmission, or spread of communicable
disease through the use of the HCT/P.

§ 1271.220
trols.

Processing and process con-

(a) General. If you are an establishment that processes HCT/Ps, you must
process each HCT/P in a way that does
not cause contamination or cross-contamination during processing, and that
prevents
the
introduction,
transmission, or spread of communicable
disease through the use of the HCT/P.
(b) Pooling. Human cells or tissue
from two or more donors must not be
pooled (placed in physical contact or
mixed in a single receptacle) during
manufacturing.
(c) In-process control and testing. You
must ensure that specified requirements, consistent with paragraph (a) of
this section, for in-process controls are
met, and that each in-process HCT/P is
controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received and documented. Sampling of in-process HCT/Ps
must be representative of the material
to be evaluated.
(d) Dura mater. (1) When there is a
published validated process that reduces
the
risk
of
transmissible
spongiform encephalopathy, you must
use this process for dura mater (or an
equivalent process that you have validated), unless following this process
adversely affects the clinical utility of
the dura mater.
(2) When you use a published validated process, you must verify such a
process in your establishment.
§ 1271.225

Process changes.

Any change to a process must be
verified or validated in accordance
with § 1271.230, to ensure that the
change does not create an adverse impact elsewhere in the operation, and
must be approved before implementation by a responsible person with appropriate knowledge and background.
You must communicate approved
changes to the appropriate personnel in
a timely manner.
§ 1271.230

Process validation.

(a) General. Where the results of processing described in § 1271.220 cannot be
fully verified by subsequent inspection

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