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Very often, working with documents, like Ich Qie, can be a challenge, especially if you received them online or via email but don’t have access to specialized software. Of course, you can use some workarounds to get around it, but you risk getting a document that won't meet the submission requirements. Using a printer and scanner isn’t an option either because it's time- and resource-consuming.
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ICH Q4 is split into Q4A (Pharmacopoeial Harmonization) and Q4B (Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions). ICH Q4 and Q4B are often used interchangeably and this is the case in this chapter. The objective of harmonization is to develop interchangeable methods or requirements.
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