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Related post: dimensional parameters are unnecessary and in many instances are not
informative. Dimensional parameters were intentionally left out because current
knowledge is limited as to what size fiber does not constitute a hazard.
Furthermore, the suggested fiber length of at least 100 microns is unacceptable
because most asbestos fibers released from asbestos-cellulose filters are less
than 70 microns in length.
The American Society for Testing and Materials' specifications (ASTM Manual
F24-65, Standard Methods for Measuring and Counting Particulate Contamination on
Surfaces) for defining "fiber" are not pertinent to the subject at hand. They
were developed specifically for particles on surfaces of mechanical objects as
related to abrasion of such objects.
To eliminate any concern that the definition of fiber would include
particles intentionally present, as in drug suspensions, the final regulation is
modified by adopting the concept of particle contamination. Therefore, fiber
means any particulate contaminate having a length at least three times its
64. Comment was received regarding 210.3(b)(6) that the definition for
"non-fiber-releasing filter" should include the concept of a filter "being
designed" not to release fibers after appropriate pretreatment. Another comment
said a requirement for non-release of fibers is unrealistically absolute, i.e.,
no known filter could meet the definition.
The Commissioner advises that the final regulation adopting the definition
for "non-fiber-releasing filter," published in the FEDERAL REGISTER of March 14,
1975 (40 FR 11865), addressed similar issues. In responding to comments in that
document, the Commissioner concluded the definition should include the concept
that after appropriate pretreatment such as washing or flushing, the filter will
not continue to release fibers into the drug that is being filtered. The design
concept is therefore taken into account because of the distinction made between
filters which release fibers by media migration, i.e., continuous release due to
the nature of the filter, and filters which contain fibers from structural
supports and contamination.
With regard to the comment that the requirement for nonrelease of fibers is
unrealistically absolute, the Commissioner finds that the definition clearly
describes types of fibers that are relied upon in the industry as "non-fiber
releasing." The Commissioner concedes that any filter may release an occasional
particle, some of which may meet the definition of "fiber" under 210.3(b)(5).
The purpose of the definition for "non-fiber releasing filter," which has been
applied for over 2 years without apparent misunderstanding, is to provide a
reasonable and practical description of a filter that may be fabricated from a
number of different materials and will not, in the ordinary sense, introduce
fibers into the drug product during filtration.
As discussed in detail in the preamble to the March 14, 1975 final
regulation adopting the definitions for "fiber" and "non-fiber releasing
filter", FDA is studying several issues involving fiber contamination and the
effects on humans to fiber exposure. Until such time as the Commissioner has
obtained sufficient information to alter his position on fiber contamination in
parenteral drug products without adversely affecting the public health, he Generic Propafenone
concludes that the definition for "non-fiber releasing filter" continues to be
appropriate for these regulations.
65. Comment was received that the definition of "non-fiber-releasing
filter" as written in 210.3(a)(6) would discourage the development of asbestos
filters that might not be fiber releasing.
The Commissioner advises that it is not the intention of FDA to discourage
the development of asbestos filters. In this regard, the preamble to the final
order in the FEDERAL REGISTER of March 14, 1975 (40 FR 11865) addresses this
issue in detail.
66. One comment suggested that "non-fiber-releasing filter" be redefined to
apply only to the final filtration of components and drug products.
The Commissioner concludes that the suggestion would allow use of an
asbestos filter Buy Propafenone for filtration of in-process materials. This use of asbestos
filters is unacceptable, except under the provision of 211.72(b), and would
defeat the purpose of the regulation.
67. A comment suggested that after the word "component" in 210.3(b)(7) the
phrase "other than veterinary biological immunizing or diagnostic agent" should
The Commissioner finds that articles that are not deemed drug products or
that are not under the jurisdiction of the act are not subject to these
regulations. It is not desirable or feasible to identify in these regulations
every specific class of articles that are not subject to CGMP regulations.
Veterinary biologicals have, however, been excluded by changes in 210.2. When
an interested person has a question regarding the status of another individual
product or class of products (for example, the status of an article that may be
either a drug or a device), that person may obtain a formal opinion from FDA
pursuant to 21 CFR 10.85.
68. Several comments asked that limits be placed on the term "in-process
materials" defined in 210.3(b)(9) in order to restrict it to those materials
generated "in-plant" as opposed to those materials acquired from an outside
The Commissioner agrees that the term "in-process materials" is intended to
apply to materials being processed by establishments engaged in the preparation
of a drug product. He believes this intent is clear when the term is considered
in the scope of these regulations and that no change is needed.
69. Several comments requested clarification whether the term "in-process
materials" in 210.3(b)(9) includes labels printed "in-house" and other
It was not the Commissioner's intent that "in-process materials" include
label printing. The regulations do not suggest that such labeling would
constitute in-process materials. References to labeling materials are clearly
stated in these regulations when appropriate.
70. One comment suggested that the word "materials" in 210.3(b)(9) be
changed to "ingredients."
The Commissioner concludes that the term "in-process materials" is in
current usage and sees no advantage to introducing the suggested term "in-
70a. One comment stated that 210.3(b)(9), and especially the word
"fabricated" is unclear and should be further defined to eliminate any possible
The Commissioner does not agree that the word "fabricated" is unclear when
used in this definition. This suggestion is rejected because a broad term such
as "fabricated" is appropriate here.
71. Several comments said, in the case of biologics, a "lot" may consist of
more than one batch and suggested that this be included in the definition of
"lot" in 210.3(b)(10).
Because the term "lot" has already been defined specifically for biological
products in 21 CFR 600.3(x), the Commissioner does not believe that any
modification of the definition in this part is appropriate. As previously
indicated, the more specific regulations for biological drug products take
precedent over the more general.
72. Two comments said the term "lot" was used elsewhere in the CGMP
regulations (e.g., 211.84(a)) to refer to containers and closures, which are
neither drugs nor drug products. They said either the definition in
210.3(b)(10) or the reference was incorrect.
The Commissioner notes that the definition in 210.3(b)(10) refers to the
term "drug product," but does not limit to drug products the applications of the
definition for "lot." However, the proposed definition for "batch" is limited
to drugs. Because a lot is defined as a batch or portion of a batch, the
definition for "batch" is expanded to include materials other than drugs.
Similarly, the definition for "lot number" is expanded to include other
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