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2. List of Guidances for Statistics in Regulatory Affairs

   en.wikipedia.org/wiki/List_of_Guidances_for...

   FDA: Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA Regulated Clinical Trials. This guidance describes the FDA policy that already-accrued data, relating to individuals who cease participating in a study, are to be maintained as part of the study data.

3. Continued process verification - Wikipedia

   en.wikipedia.org/wiki/Continued_process_verification

   While production variability can sometimes be obvious and even casually identified the FDA recommends using statistical tools to quantitatively detect problems and identify root causes. Initially, continued process verification should be based on quality standards established in the design phase.

4. Title 21 CFR Part 11 - Wikipedia

   en.wikipedia.org/wiki/Title_21_CFR_Part_11

   But, as with all FDA guidances, it was not intended to convey the full force of law—rather, it expressed the FDA's "current thinking" on Part 11 compliance. Many within the industry, while pleased with the more limited scope defined in the guidance, complained that, in some areas, the 2003 guidance contradicted requirements in the 1997 Final ...

5. CFR - Code of Federal Regulations Title 21

   highline.huffingtonpost.com/miracleindustry/...

   presented in tabular and graphic forms. FDA has prepared a guideline under 10.90(b) that provides information about how to prepare a summary. The summary required under this paragraph may be used by FDA or the applicant to prepare the Summary Basis of Approval document for

6. Process validation - Wikipedia

   en.wikipedia.org/wiki/Process_Validation

   Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]

7. Validation (drug manufacture) - Wikipedia

   en.wikipedia.org/wiki/Validation_(drug_manufacture)

   Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: