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A tracking system should be implemented that can very quickly identify where a protocol is, providing a picture of the current protocol production status The method and time allowed for review must also be agreed upon Review methods range from traditional circulation of a single document to each individual for comment to assembling a team for a joint review to electrically accessing the document and revising or commenting on it The method chosen must re ect the available time, resource, and technology In some cases, the resources for protocol review are a limiting factor that can critically affect the schedule [3] 8442 Validation Reports A validation report is a written document that cross-references the validation protocol, summarizes the results obtained, describes any deviations observed, and draws the necessary conclusions, including recommending changes required to correct de ciencies for the quali cation and validation performed [5].

If, in addition, all pn are identical, the stochastic variables 20, are called independent and identically normally distributed (iind). By (3.22), the general expression for q(w) = lnp(w) for normally distributed w is

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In this report it is required to present both the results and conclusions and the secure approval of the study The report should include a summary of the procedures used to clean, sample, and test as well as the physical and analytical test results or references for the same The conclusions regarding the acceptability of the results should also be included Other information would be the status of the procedures being validated, any recommendations based on the results, or any relevant information obtained during the study These include, revalidation practices (if applicable), the approved conclusions, and any deviations of the protocol that might have occurred In cases where it is unlikely that further batches of the product will be manufactured for a period.

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