21cfr1271

§ 1271.160

21 CFR Ch. I (4–1–06 Edition)

(d) Form of request. You must ordinarily make your request for an exemption or alternative in writing (hard
copy or electronically). However, if circumstances make it difficult (e.g.,
there is inadequate time) to submit
your request in writing, you may make
the request orally, and the Director
may orally grant an exemption or alternative. You must follow your oral
request with an immediate written request, to which the Director will respond in writing.
(e) Operation under exemption or alternative. You must not begin operating
under the terms of a requested exemption or alternative until the exemption
or alternative has been granted. You
may apply for an extension of an exemption or alternative beyond its expiration date, if any.
(f) Documentation. If you operate
under the terms of an exemption or alternative, you must maintain documentation of:
(1) FDA’s grant of the exemption or
alternative, and
(2) The date on which you began operating under the terms of the exemption or alternative.
(g) Issuance of an exemption or alternative by the Director. In a public health
emergency, the Director may issue an
exemption from, or alternative to, any
requirement in part 1271. The Director
may issue an exemption or alternative
under this section if the exemption or
alternative is necessary to assure that
certain HCT/Ps will be available in a
specified location to respond to an unanticipated immediate need for those
HCT/Ps.
§ 1271.160 Establishment and maintenance of a quality program.
(a) General. If you are an establishment that performs any step in the
manufacture of HCT/Ps, you must establish and maintain a quality program intended to prevent the introduction, transmission, or spread of communicable diseases through the manufacture and use of HCT/Ps. The quality
program must be appropriate for the
specific HCT/Ps manufactured and the
manufacturing steps performed. The
quality program must address all core
CGTP
requirements
listed
in
§ 1271.150(b).

(b) Functions. Functions of the quality program must include:
(1) Establishing and maintaining appropriate procedures relating to core
CGTP requirements, and ensuring compliance with the requirements of
§ 1271.180 with respect to such procedures, including review, approval, and
revision;
(2) Ensuring that procedures exist for
receiving, investigating, evaluating,
and documenting information relating
to core CGTP requirements, including
complaints, and for sharing any information pertaining to the possible contamination of the HCT/P or the potential for transmission of a communicable disease by the HCT/P with the
following:
(i) Other establishments that are
known to have recovered HCT/Ps from
the same donor;
(ii) Other establishments that are
known to have performed manufacturing steps with respect to the same
HCT/P; and
(iii) Relating to consignees, in the
case of such information received after
the HCT/P is made available for distribution, shipped to the consignee, or
administered to the recipient, procedures must include provisions for assessing risk and appropriate followup,
and evaluating the effect this information has on the HCT/P and for the notification of all entities to whom the affected HCT/P was distributed, the quarantine and recall of the HCT/P, and/or
reporting to FDA, as necessary.
(3) Ensuring that appropriate corrective actions relating to core CGTP requirements, including reaudits of deficiencies, are taken and documented, as
necessary. You must verify corrective
actions to ensure that such actions are
effective and are in compliance with
CGTP. Where appropriate, corrective
actions must include both short-term
action to address the immediate problem and long-term action to prevent
the problem’s recurrence. Documentation of corrective actions must include,
where appropriate:
(i) Identification of the HCT/P affected and a description of its disposition;
(ii) The nature of the problem requiring corrective action;

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Food and Drug Administration, HHS

§ 1271.190

(iii) A description of the corrective
action taken; and
(iv) The date(s) of the corrective action.
(4) Ensuring the proper training and
education of personnel involved in activities related to core CGTP requirements;
(5) Establishing and maintaining appropriate monitoring systems as necessary to comply with the requirements of this subpart (e.g., environmental monitoring);
(6) Investigating and documenting
HCT/P deviations and trends of HCT/P
deviations relating to core CGTP requirements and making reports if required under § 1271.350(b) or other applicable regulations. Each investigation
must include a review and evaluation
of the HCT/P deviation, the efforts
made to determine the cause, and the
implementation of corrective action(s)
to address the HCT/P deviation and
prevent recurrence.
(c) Audits. You must periodically perform for management review a quality
audit, as defined in § 1271.3(gg), of activities related to core CGTP requirements.
(d) Computers. You must validate the
performance of computer software for
the intended use, and the performance
of any changes to that software for the
intended use, if you rely upon the software to comply with core CGTP requirements and if the software either is
custom software or is commercially
available software that has been customized or programmed (including
software programmed to perform a user
defined calculation or table) to perform
a function related to core CGTP requirements. You must verify the performance of all other software for the
intended use if you rely upon it to comply with core CGTP requirements. You
must approve and document these activities and results before implementation.
§ 1271.170 Personnel.
(a) General. You must have personnel
sufficient to ensure compliance with
the requirements of this part.
(b) Competent performance of functions.
You must have personnel with the necessary education, experience, and
training to ensure competent perform-

ance of their assigned functions. Personnel must perform only those activities for which they are qualified and
authorized.
(c) Training. You must train all personnel, and retrain as necessary, to
perform their assigned responsibilities
adequately.
§ 1271.180 Procedures.
(a) General. You must establish and
maintain procedures appropriate to
meet core CGTP requirements for all
steps that you perform in the manufacture of HCT/Ps. You must design these
procedures to prevent circumstances
that increase the risk of the introduction, transmission, or spread of communicable diseases through the use of
HCT/Ps.
(b) Review and approval. Before implementation, a responsible person must
review and approve these procedures.
(c) Availability. These procedures
must be readily available to the personnel in the area where the operations
to which they relate are performed, or
in a nearby area if such availability is
impractical.
(d) Standard procedures. If you adopt
current standard procedures from another organization, you must verify
that the procedures meet the requirements of this part and are appropriate
for your operations.
§ 1271.190 Facilities.
(a) General. Any facility used in the
manufacture of HCT/Ps must be of suitable size, construction, and location to
prevent contamination of HCT/Ps with
communicable disease agents and to
ensure orderly handling of HCT/Ps
without mix-ups. You must maintain
the facility in a good state of repair.
You must provide lighting, ventilation,
plumbing, drainage, and access to sinks
and toilets that are adequate to prevent the introduction, transmission, or
spread of communicable disease.
(b) Facility cleaning and sanitation. (1)
You must maintain any facility used in
the manufacture of HCT/Ps in a clean,
sanitary, and orderly manner, to prevent the introduction, transmission, or
spread of communicable disease.
(2) You must dispose of sewage,
trash, and other refuse in a timely,
safe, and sanitary manner.

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