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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 paragraph. 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 below. 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 specification. 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 unjustifiably costly. 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 "original." 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 description of." The Commissioner agrees that it is not necessary to describe fully a
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