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40, which deal with the retesting of components and drug product containers and closures Correspondences to regulation 21189 are covered in Subchapter 561, which states the requirements for the handling of rejected components and drug product containers and closures Correspondences to regulation 21194 are covered in Subchapter 548, which states the requirements for drug product containers and closures Correspondences in WHO GMP Guideline In the WHO GMP guideline [36] issues related to control of components and drug product containers and closures are covered in s 14 (Materials), 16 (Good Practices in Production), and 17 (Good Practices in Quality Control) Correspondences to regulation 21180 are covered in Subchapters, 145, 1413, 1414, 1419 1421, and 162, which state the requirements for the handling, storing, and identi cation of components (starting materials) and drug product containers and closures (primary packaging materials).

Figure 2.14. Normal phase chromatography. (a) Samples interact with a polar stationary phase in the presence of N-heptane and are eluted by increasingly polar mobile phase. (b) Elution pro le obtained with sample components 1 to 3 identical to those in Figure 2.13. Note that these elute in inverse order compared to reversed phase chromatography percent. Methanol is shown by dashed lines.

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Correspondences to regulation 21182 are covered in Subchapters 144, 149 1411, and 1419, which state the requirements for receipt, testing, identi cation, and storage of untested components and drug product containers and closures Correspondences to regulation 21184 are covered in Subchapters 1412, 1415, and 177 1717 The requirements for sampling and testing are covered in Subchapters 177 1717 and 1412 Subchapter 1415 states the requirements for the approved use of components and drug product containers and closures Correspondences to regulation 21186 are covered in Subchapter 145, which states the requirements for the storage conditions and the rotation of the storage Correspondences to regulation 21187 are covered in Subchapter 1413, which states the requirements for the retesting of approved components.

TABLE 25 Contents of Subpart J of Part 211 of U.S. GMP Regulations Covering Records and Reports [7] Section CFR 211.180 CFR 211.182 CFR 211.184 CFR 211.186 CFR 211.188 CFR 211.192 CFR 211.194 CFR 211.196 CFR 211.198 Subject General requirements Equipment cleaning and use log Component, drug product container, closure, and labeling records Master production and control records Batch production and control records Production record review Laboratory records Distribution records Complaint les

The WHO GMP guideline does not cover the requirements for the retesting of drug product containers and closures Correspondences to regulation 21189 are covered in Subchapter 1428, which states the requirements for the handling of rejected components and drug product containers and closures Correspondences to regulation 21194 are covered in Subchapter 1619, which states the requirements for the drug product containers and closures 2146 Production and Process Controls.

In this paragraph, the main black-box approaches are described: an example of technologyindependent model for time-domain or harmonic balance analysis, a model for nonlinear frequency-domain analysis (spectral balance) and behavioural models, mostly based on a describing-function approach.

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8. On the Pick Location screen, the wizard prompts you to pick two corners to define the size of the viewport configuration that you chose. If you chose more than one viewport, these two corners define the extents of all of the viewports combined, not the extents of the individual viewports. Click Next. 9. On the last screen, click Finish to close the wizard and return to your drawing.

You can also create a new, empty tool palette by using the Customize dialog box. See the Customizing Tool Palettes section in 29 for details.

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