招聘信息英文FDA CFR 211 EN

2021年1月19日发(作者：条)

Sec. 210.1 Status of current good manufacturing practice regulations.


(a) The regulations set forth in this part and in parts 211 through 226 of this chapter contain the
minimum
current
good
manufacturing
practice
for
methods
to
be
used
in,
and
the
facilities
or
controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that
such
drug
meets
the
requirements
of
the
act
as
to
safety,
and
has
the
identity
and
strength
and
meets the quality and purity characteristics that it purports or is represented to possess.
(b) The failure to comply with any regulation set forth in this part and in parts 211 through 226 of
this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to
be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is
responsible for the failure to comply, shall be subject to regulatory action.
(c)
Owners
and
operators
of
establishments
engaged
in
the
recovery,
donor
screening,
testing
(including donor testing), processing, storage, labeling, packaging, or distribution of human cells,
tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271.3(d) of this chapter,
that are drugs (subject to review under an application submitted under section 505 of the act or
under a biological product license application under section 351 of the Public Health Service Act),
are subject to the donor-eligibility and applicable current good tissue practice procedures set forth
in part 1271 subparts C and D of this chapter, in addition to the regulations in this part and in parts
211 through 226 of this chapter. Failure to comply with any applicable regulation set forth in this
part, in parts 211 through 226 of this chapter, in part 1271 subparts C of this chapter, or in part D
of this chapter with respect to the manufacture, processing, packing or holding of a drug, renders
an HCT/P adulterated under section 501(a)(2)(B) of the act. Such HCT/P, as well as the person
who is responsible for the failure to comply, is subject to regulatory action.
Sec. 210.2 Applicability of current good manufacturing practice regulations.

(a) The regulations in this part and in parts 211 through 226 of this chapter as they may pertain to
a drug; in parts 600 through 680 of this chapter as they may pertain to a biological product for
human
use;
and
in
part
1271
of
this
chapter
as
they
are
applicable
to
a
human
cell,
tissue,
or
cellular
or
tissue-based
product
(HCT/P)
that
is
a
drug
(subject
to
review
under
an
application
submitted
under
section
505
of
the
act
or
under
a
biological
product
license
application
under
section 351 of the Public Health Service Act); shall be considered to supplement, not supersede,
each other, unless the regulations explicitly provide otherwise. In the event of a conflict between
applicable
regulations
in
this
part
and
in
other
parts
of
this
chapter,
the
regulation
specifically
applicable to the drug product in question shall supersede the more general.

(b) If a person engages in only some operations subject to the regulations in this part, in parts 211
through
226
of
this
chapter,
in
parts
600
through
680
of
this
chapter,
and
in
part
1271
of
this
chapter, and not in others, that person need only comply with those regulations applicable to the
operations in which he or she is engaged.

(c) An investigational drug for use in a phase 1 study, as described in 312.21(a) of this chapter, is
subject to the statutory requirements set forth in 21 U.S.C. 351(a)(2)(B). The production of such
drug
is
exempt
from
compliance
with
the
regulations
in
part
211
of
this
chapter.
However,
this
exemption
does
not
apply
to
an
investigational
drug
for
use
in
a
phase
1
study
once
the
investigational drug has been made available for use by or for the sponsor in a phase 2 or phase 3
study, as described in 312.21(b) and (c) of this chapter, or the drug has been lawfully marketed. If
the investigational drug has been made available
in a phase 2 or phase 3 study or
the drug has
been lawfully marketed, the drug for use in the phase 1 study must comply with part 211.