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Related post: result in cross-contamination problems. For example, removal of the cake from
penicillin fermentation equipment could result in airborne contamination from
partly dry or dry cake. With regard to the respondent's second example, the
Commissioner is revising this requirement to make it apply only to production
operations and not to storage, such as warehousing of the Purchase Triamcinolone Online penicillin product in
148. Comments were made that proposed 211.46(e) was superfluous because
211.42(d) already required separate facilities for penicillin and nonpenicillin
The Commissioner believes it is important to make clear in these
regulations that completely separate air handling facilities for penicillin and
nonpenicillin production are required. Section 211.42(d) is written to allow
penicillin production in the same buildings as nonpenicillin production if the
penicillin production areas can be completely separated from all others.
However, because it is possible for air-handling systems between penicillin and
nonpenicillin production areas to be interconnected, the Commissioner finds it
necessary to state that any such interconnection would be unacceptable.
149. One comment said proposed 211.46(e) should specify whether the air-
handling system is intended for outgoing or incoming air.
There is no single answer to this point since the specific requirements for
a particular installation will depend on individual circumstances. The purpose
of the requirement is that no cross-contamination occur between penicillin and
nonpenicillin operations. The means by which the objective is achieved may
require filtration of incoming air of Buy Cheap Triamcinolone filtration of outgoing air or both.
150. A number of comments on 211.48(a) said water received from municipal
sources and certified as meeting the requirements of Subpart J of 42 CFR Part 72
should not have to be tested as if it were another component.
It was not the Commissioner's intent that potable water received from
municipal sources require Triamcinolone Creme acceptance testing by a drug manufacturer unless the
water is obtained from sources that do not control the water quality to assure
compliance with Public Health Service standards. Of course, water of unknown
quality such as a firm's own wells must be tested, and potable water coming into
the plant system should not be adversely affected by the in-plant plumbing.
151. A number of comments indicated that it is not necessary and is Triamcinolone Lotion very
expensive to require that all water in a plant be potable water. They pointed
out that some systems such as sprinklers for fire control, cooling equipment,
and Buy Triamcinolone boiler feed do not require potable water.
In light of these comments, the Commissioner is revising 211.48(a) to
eliminate the prohibition against nonpotable water within a plant.
152. One comment said potable water should be analyzed for polychlorinated
biphenyls and chloroform, and tolerances should be set because of the potential
danger to health represented by these contaminants.
The Commissioner recognizes that potable water may contain amounts of
environmental chemical contaminants at levels that have not been clearly
established as having significant adverse effects when ingested. Government
agencies are investigating more meaningful specifications for testing potable
water for potentially harmful impurities not already included in the standards.
Therefore, FDA has not included such requirements for testing and acceptance of
potable water in these regulations.
153. Several comments objected to the designation of traps to prevent back-
siphonage in 211.48(b). The comments said it is general opinion that traps do
not prevent back-siphonage, but check valves or air break arrangements would do
The Commissioner agrees with these comments, and 211.48(b) is revised to
reflect the suggested change.
154. One comment objected to equipping drains with traps because of the
inflationary impact and requested that this Triamcinolone 0.1 paragraph be deleted.
The Commissioner notes that this paragraph is revised to eliminate the
reference to traps. It now Cheap Triamcinolone requires the use of air breaks Order Triamcinolone or other mechanical
device which may increase or decrease the cost to this person, depending on his
present method of preventing back-siphonage. However, the Commissioner
considers that the necessity of preventing back-siphonage outweighs the cost
WASHING AND TOILET FACILITIES
155. Several comments on 211.52 Triamcinolone Online argued that it is not current industry
practice to provide "hot" water, but rather to provide "tempered" water, thus
conserving energy while maintaining adequate sanitation facilities.
The Commissioner has been unable determine that there is a consensus as to
what is meant by "tempered water." Therefore, he is concerned that the word
"tempered" might allow the use of water that is of insufficient temperature for
adequate Generic Triamcinolone cleaning.
156. A comment suggested that the word "easily" be deleted from 211.52
because location of washing facilities may be hindered or prohibited by local
plumbing codes. Further comment said the word "easily" Purchase Triamcinolone is most subjective and
capable of differing interpretation.
The Commissioner is not convinced that plumbing codes would prohibit easily
accessible washing facilities in establishments that are properly designed.
Further, the Commissioner believes that the word "easily" is concise Triamcinolone Ointment enough to
adequately describe the intent of the section. Therefore, the wording as
proposed is retained in the final regulation.
157. Several comments contended that proposed 211.54 should be deleted
since it substance is covered by the Animal Welfare Act of 1970 (Pub. L. 91-579,
7 U.S.C. 2131). Other comments said this section implies that housing for
laboratory animals is required whether or not a firm maintains laboratory
The Commissioner does not believe it is improper to make the substance of
another regulation a requirement in th CGMP regulations. It should be Order Triamcinolone Online obvious
that if a firm is not engaged in a type of operation covered by these
regulations, then any requirement that pertains to that type of operation does
not apply to that firm. In reviewing this proposed section, however, the
Commissioner has concluded that its intent is adequately covered in 211.173.
Therefore, 211.54 is deleted in the final regulation.
158. Several comments on 211.56(a) said it is impossible to maintain all
buildings completely free from rodents, birds, insects, vermin, trash, and
organic decaying matter. Triamcinolone Cream In most buildings there is an accumulation of trash
daily in various waste baskets and in trash accumulation areas for papers and
The Commissioner agrees that the intent of this section could be more
clearly stated, and the text is revised accordingly.
159. Several comments requested the deletion of the phrase "in detail" from
211.56(b), because, according to the language in this paragraph, manufacturers
would be required to document all minute details.
The Buy Triamcinolone Online Commissioner believes that in some cases, detailed descriptions of
cleaning procedures may be necessary to assure complete and proper cleaning. In
others, that level of detail may not be necessary or appropriate. The
Commissioner believes that there should be a reasonable standard in describing
the details of these procedures. Therefore, this paragraph Acetonide Triamcinolone is revised to
require "sufficient" detail.
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