[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 728-729]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS--Table 
 
                 Subpart D_Current Good Tissue Practice
 
Sec.  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 Sec.  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 
Sec.  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

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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;
    (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 Sec.  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 Sec.  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.