21cfr1271

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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§ 1271.195

21 CFR Ch. I (4–1–06 Edition)

(c) Operations. You must divide a facility used in the manufacture of HCT/
Ps into separate or defined areas of
adequate size for each operation that
takes place in the facility, or you must
establish and maintain other control
systems to prevent improper labeling,
mix-ups,
contamination,
cross-contamination, and accidental exposure of
HCT/Ps
to
communicable
disease
agents.
(d) Procedures and records. (1) You
must establish and maintain procedures for facility cleaning and sanitation for the purpose of preventing the
introduction, transmission, or spread
of communicable disease. These procedures must assign responsibility for
sanitation and must describe in sufficient detail the cleaning methods to be
used and the schedule for cleaning the
facility.
(2) You must document, and maintain records of, all cleaning and sanitation activities performed to prevent
contamination of HCT/Ps. You must retain such records 3 years after their
creation.
§ 1271.195 Environmental control and
monitoring.
(a) Environmental control. Where environmental conditions could reasonably
be expected to cause contamination or
cross-contamination of HCT/Ps or
equipment, or accidental exposure of
HCT/Ps
to
communicable
disease
agents, you must adequately control
environmental conditions and provide
proper conditions for operations. Where
appropriate, you must provide for the
following control activities or systems:
(1) Temperature and humidity controls;
(2) Ventilation and air filtration;
(3) Cleaning and disinfecting of
rooms and equipment to ensure aseptic
processing operations; and
(4) Maintenance of equipment used to
control conditions necessary for aseptic processing operations.
(b) Inspections. You must inspect each
environmental control system periodically to verify that the system, including necessary equipment, is adequate
and functioning properly. You must
take appropriate corrective action as
necessary.

(c) Environmental monitoring. You
must monitor environmental conditions where environmental conditions
could reasonably be expected to cause
contamination or cross-contamination
of HCT/Ps or equipment, or accidental
exposure of HCT/Ps to communicable
disease agents. Where appropriate, you
must provide environmental monitoring for microorganisms.
(d) Records. You must document, and
maintain records of, environmental
control and monitoring activities.
§ 1271.200

Equipment.

(a) General. To prevent the introduction, transmission, or spread of communicable diseases, equipment used in
the manufacture of HCT/Ps must be of
appropriate design for its use and must
be suitably located and installed to facilitate operations, including cleaning
and maintenance. Any automated, mechanical, electronic, or other equipment used for inspection, measuring,
or testing in accordance with this part
must be capable of producing valid results. You must clean, sanitize, and
maintain equipment according to established schedules.
(b) Procedures and schedules. You
must establish and maintain procedures for cleaning, sanitizing, and
maintaining equipment to prevent
malfunctions, contamination or crosscontamination, accidental exposure of
HCT/Ps
to
communicable
disease
agents, and other events that could
reasonably be expected to result in the
introduction, transmission, or spread
of communicable diseases.
(c) Calibration of equipment. Where appropriate, you must routinely calibrate
according to established procedures
and schedules all automated, mechanical, electronic, or other equipment
used for inspection, measuring, and
testing in accordance with this part.
(d) Inspections. You must routinely
inspect equipment for cleanliness, sanitation, and calibration, and to ensure
adherence to applicable equipment
maintenance schedules.
(e) Records. You must document and
maintain records of all equipment
maintenance, cleaning, sanitizing, calibration, and other activities performed
in accordance with this section. You

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