| || |
Special Internet Prices.
Fast & Guaranteed Worldwide Delivery!
Secure & FAST Online Ordering.
Our Drugstore Is The Most Trusted Online Drug Supplier.
Related post: containers with no reference to the amount of sample in each container. The
size of sample containers could range, for example, from a liter container to a
container that holds only a few grams. Further, the Commissioner does not
believe this requirement to be either unreasonable or burdensome.
The Commissioner also concludes that the meaning of the word "source" in
211.194(a)(1) needs clarification. "Source" of the sample is intended to mean
the location, e.g., a specific drum number and storage area or in-process phase.
The final regulation is revised in this regard.
475. Several comments suggested that the last sentence of 211.194(a)(2) be
deleted because the requirement was stated in the second sentence in this
The Commissioner does not agree with these comments. The last sentence of
211.194(a)(2) requires that testing methods, whether such methods have been
developed by the manufacturer or are from official compendia, be verified under
actual conditions of use. The Commissioner does not believe that the requirement
in this last sentence is explicitly stated previously.
476. One comment argued that the requirement in 211.194(a)(2) that
laboratory records contain a statement of each analytical method used in the
analysis of a sample should be limited to assays and should not extend to other
tests such as physical tests.
The Commissioner does not agree that the requirement should be limited to
assays of components of drug products. Tests or examinations other than assays
are an integral part of the history of a drug product, especially in situations
where a physical test might be as critical as an assay--for example, in
determining particle size, dissolution rate, or tablet hardness. Recognizing,
however, that this section as worded in the proposal is somewhat ambiguous in
this regard, the Commissioner is rewording the final regulation to reflect that
the requirement applies to all tests, including examinations and assays.
477. Several comments suggested that the words "where appropriate," "where
meaningful," or "where required" be added at the end of 211.194(a)(3). One
comment reasoned that the size of the sample is not pertinent for many
laboratory tests, e.g., melting point, infrared identification, qualitative
colorimetric spot tests, and pH.
The Commissioner accepts the intent of these suggestions and is revising
211.194(a)(3) accordingly by adding the phrase "where appropriate" in order to
provide for test procedures where a Ticlopidine Clopidogrel nonspecific weight or measure is used.
478. Several comments requested deletion of the requirement in
211.194(a)(4) to include all "graphs, charts, and spectra from laboratory
instrumentation" in laboratory records because they are not needed and would
create additional files.
The Commissioner believes that all graphs, charts, and spectra used to show
a product's acceptability must be retained for future reference. These records
would be needed to carry out any investigation required under these regulations.
479. Several comments requested deletion of the requirement in
211.194(a)(4) that laboratory records include data on testing of drug product
containers and closures.
The Commissioner believes that the records generated showing the
acceptability or nonacceptability of the containers and closures are as
necessary as those for components, in-process materials, or drug products and
therefore rejects the request for deletion.
480. Several comments requested 211.194(a) (4) and (5) be revised to take
into account calculations and data derived from automatic testing equipment,
such as computers.
The Commissioner notes that 211.68 already provides for calculations and
data derived from automated equipment and that such provisions need not be
restated in every section where they would apply.
481. In considering comments relating to proposed 211.194(a)(6), the
Commissioner concludes that those requirements are more appropriately codified
as 211.194(b). Specific comments are responded to beginning with paragraph 488
482. Some comments on proposed 211.194(a)(7) (now 211.194(a)(6))
recommended that the phrase "drug product container, closure" be altered to
apply only to human drug product containers and closures.
The Commissioner finds that recordkeeping should apply to pertinent
information regardless of the intended use of the drug product.
483. Several comments on proposed 211.194(a)(7) objected to requiring the
laboratory to make a comparison of the test result against an established
standard, especially where a standard is not known to the laboratory personnel.
Some of these comments suggested alternative wording to clarify this. One
comment objected to requiring this statement if the reported result was close to
The Commissioner believes there must be established standards that all test
results are compared against, whether they be precise standards, an acceptable
range of values within maximum and minimum values, or the absence or presence of
certain attributes. The Commissioner does not Buy Ticlopidine understand how respondents would
evaluate the significance of test results if no standards for comparison exist.
Therefor, this requirement as proposed is retained in the final regulation.
484. Several comments on proposed 211.194(a)(8) (now 211.194(a)(7))
suggested the use of alternative systems of identification instead of a full
signature of the person who performs each assay or test. Suggested alternatives
were employee numbers or initials.
The Commissioner agrees that a full signature is not needed in this
instance and therefore is amending 211.194(a)(7) to allow the use of initials.
485. Several comments suggested that 211.194(a)(8) (proposed as
211.194(a)(9)) be deleted on a variety of grounds--it would be a waste of
technical manpower; it would be inflationary; and it is not current practice for
the veterinary industry. Other comments suggested provision for a random review
or the insertion of the phrase "when such records are audited."
The Commissioner has evaluated all these comments in light of the objective
of having independent verification of the laboratory work to insure that the
proper procedures were used and followed, that the calculations are correct, and
that the record is complete. A review of laboratory records is necessary to
insure that the correct test was performed, that the calculations are correct,
and that the record is complete. This is not wasteful of resources or
The Commissioner finds it difficult to accept the stated premise that the
veterinary drug industry does not review laboratory records to determine whether
the proper tests, assays, or examinations have been performed and that the
results are valid. It is the Commissioner's belief that drugs for veterinary
use, like drugs for human use, must be produced under appropriate control.
The Commissioner rejects the suggested revisions that limit the review to a
random basis Ticlopidine Hydrochloride or to periodic Ticlopidine 250 Mg audits. The analytical record for each batch must
be reviewed in order to detect whether or not the correct procedure was used,
the calculations are correct, and the laboratory record is complete.
486. Some comments suggested that the records reviewed need not always be
The Commissioner notes that "original" is used to convey the intent that
the records reviewed be those which contain the data used in conducting tests.
The original records give the necessary assurance that complete information is
being reviewed. Further, the Commissioner believes it is feasible, and does not
believe it is burdensome, to require that the original records be reviewed.
487. One comment suggested that the word "signature" be substituted for the
word "endorsement" in 211.194(a)(8).
To clarify 211.194(a)(8), it is revised to state that the records shall
consist of initials or signature.
488. One comment on proposed 211.194(a)(6) (now 211.194(b)) suggested
inclusion of the phrase "or suitable reference to" after the phrase "a full
The Commissioner agrees that it is not necessary to describe fully a
Related links: coreg price usa, 10 mg abilify cost, Buy Accutane Uk, septra antibiotic generic, Telmisartan Micardis, Elavil 10 Mg, zyrtec cheapest price, order actos online, iv flagyl costs, Buy Fluticasone Propionate Nasal Spray
| || |