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95. With respect to the quality control unit's authority and responsibility
under 211.22(a) for approval and/or rejection of raw materials, in-process
materials, and finished products, one person asked that other alternatives be
permitted when materials may be suitable for other purposes and uses than those
originally intended.
Use of the word "reject" does not necessarily mean that the rejected
material must be destroyed. When materials are ordered by a manufacturer, they
are ordered with a particular purpose in mind. If testing of a material shows
that it is not suitable for a particular use, it may be used for that purpose
and, therefore, is rejected. It may, however, be suitable for other uses
requiring a material with differing specifications.
96. Several comments proposed that 211.22(a) be modified so that the
quality control unit would not have to have the responsibility to review all
labeling unless it is connected with the manufactured dosage form. The
reasoning was that some promotional literature, not physically associated with
the drug product, had been defined as labeling in court suits where FDA charged
misbranding of a product with promotional literature, but that such material was
not labeling in the sense in which these regulations referred to labeling.
The Commissioner Allegra Fexofenadine notes that the scope of the CGMP regulations is to set
forth the facilities, methods, and controls to be used for the manufacture,
processing, packing, or holding of a drug product. It is not the purpose of the
CGMP regulations to control labeling such as promotional literature that is not
associated with the drug product during its preparation under CGMP regulations.
97. Comments asked for modification in the last sentence of 211.22(a)
relating to production of drugs under contract by another company. They
suggested that the contractor could release drugs for distribution on his own
responsibility if a certificate of analysis showed compliance with appropriate
specifications. Others suggested that the responsibility for approving or
rejecting drug products produced by contractors appeared in this paragraph to
rest with the contractor.
This paragraph clearly says that the quality control unit of a contracting
firm must approve or reject drug products produced by contractors. The
Commissioner believes this is proper because, in Fexofenadine Tablets the circumstances described,
the contractor does not own the goods, but merely performs a service for the
contracting firm. The responsibility to approve release of a drug product for
distribution must rest with the owner of the drug product.
98. A number of persons responding to the proposal objected to the example
of bioequivalence testing as one of the tests which must be performed in a
quality control unit's laboratory. Some said this type What Is Fexofenadine of testing was normally
done outside the quality control unit, such as by a medical unit. Others
complained that bioequivalence standards are in a state of flux and have not as
yet been established.
Bioequivalence tests may include tests such as dissolution tests, which are
generally done in the quality control unit's laboratory. They also Cheap Fexofenadine may include
in vivo tests done by medical units within or outside the firm. The
Commissioner agrees, therefore, that this example is not necessarily one which
generally represents the work done in the quality control laboratory. Although
he is deleting the bioequivalence testing example, in vitro dissolution tests
for bioequivalence are in fact an example of the type of work that could and
should be done in the quality control laboratory.
99. Two comments suggested either deleting the reference in 211.22(b) to
"packaging materials" as one of the articles tested in the quality control
laboratory, or changing it to "packing materials," on the basis that the Fexofenadine 180
examination for suitability of such materials is more properly a function of the
shipping department and relates Fexofenadine Allegra solely to protective qualities to prevent
mutilation or breakage of drug product containers.
Breakage of containers can cause product adulteration and mutilation of
containers, which may result in product misbranding. The protection of drug
products from such mechanical damage is just as much a Buy Fexofenadine function of the
maintenance of drug product quality as placing light-sensitive products in
light-resistent containers or labeling a product with its proper name and an
accurate statement of its potency. The Commissioner notes that primary
responsibility for selecting specifications for packaging materials may be
assigned to the shipping department of a firm. Under 211.22, the quality
control unit is only responsible for testing and approving (or rejecting)
packaging materials in accordance with these specifications. Therefore, no
change is needed in the section.
100. Several comments proposed eliminating from 211.22(b) Generic Fexofenadine the statement
regarding approval (or rejection) of materials used in manufacturing and
suggested use of words like "evaluation" or "disposition." It was also
suggested by others that "or" be placed between "and" and "approval" to allow
for instances described as not requiring testing for approval.
Several discussions appear in this preamble relating to the use of the
words "approval" and "rejection." These words mean either that an article may
or may not be used for production of a drug product. Reprocessing, reworking,
refining, diversion to other acceptable uses, returning to the supplier, or
destruction are all actions that may occur after a decision to reject and are in
no way precluded by the rejection decision unless specifically stated by the
manufacturer.
101. Clarification of the option of using an outside testing laboratory was
asked by respondents who wanted an explicit statement in 211.22(b) of the
acceptability of this means of product examination.
The thrust of 211.22(b) is that adequate laboratory facilities shall be
available to the quality control unit from whatever source. The paragraph does
not require those facilities to be owned and operated by the drug product
manufacturer, nor does it prohibit the manufacturer from Buy Fexofenadine Online using a contract
testing facility. The Commissioner does not feel clarification is needed in
211.22(b).
102. Four comments recommended deletion of 211.22(c) entirely, because
either (1) the requirements Fexofenadine Online are adequately covered in 211.22(a), or (2) Order Fexofenadine units of
a firm other than the quality control unit have greater expertise in specific
areas.
The provisions of paragraph 211.22(a) differ from those of paragraph (c) in
that paragraph (a) relates to the actual production of a product, while
paragraph (c) covers events which occur before production. The Commissioner
realizes that not all expertise rests with the quality control unit, and he does
not believe that the quality control unit should be solely responsible for
developing and implementing all procedures and specifications impacting on drug
product quality. A manufacturer may assign primary and initial Fexofenadine 180 Mg responsibility
for selecting procedures or specifications to the persons or units it believes
most qualified. The Commissioner's intent is that the quality control unit be
responsible for making sure that the procedures and specifications developed are Fexofenadine 180mg
appropriate and followed.
103. One comment indicated that the proposed 211.22(c) does not allow minor
equipment changes that do not bear on drug quality, unless such changes are
first approved by the quality control unit.
Section 211.22(c) is limited to those procedures and specifications that
impact Fexofenadine Buy on drug quality. Moreover, the paragraph does not prevent the production
personnel from making minor equipment adjustments that may affect drug quality
without the quality control unit's approval of the specific change. It does
require that the procedures regarding such equipment adjustment be reviewed in
advance by the quality control unit.
104. A comment suggested that 211.22(c) be expanded to provide for
specification committees, formula committees, and others instead of making the
quality control unit totally responsible.
As already explained, input into specifications and procedures may come
from any appropriate Fexofenadine Hydrochloride source. If a firm chooses to utilize specification and/or
formula committees, it is not prohibited from doing so by these regulations.
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