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HandWiki. Validation (Drug Manufacture). Encyclopedia. Available online: https://encyclopedia.pub/entry/30049 (accessed on 25 September 2026).
HandWiki. Validation (Drug Manufacture). Encyclopedia. Available at: https://encyclopedia.pub/entry/30049. Accessed September 25, 2026.
HandWiki. "Validation (Drug Manufacture)" Encyclopedia, https://encyclopedia.pub/entry/30049 (accessed September 25, 2026).
HandWiki. (2022, October 19). Validation (Drug Manufacture). In Encyclopedia. https://encyclopedia.pub/entry/30049
HandWiki. "Validation (Drug Manufacture)." Encyclopedia. Web. 19 October, 2022.
Validation (Drug Manufacture)
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The content is sourced from: https://handwiki.org/wiki/Validation_(drug_manufacture)

Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. 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: Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:

validation compliance pharmaceutical

References

  1. Agalloco, J. (1995). "Validation: an unconventional review and reinvention". Validation: An Unconventional Review and Reinvention 49 (4): 175–179. 
  2. Hoffmann, A., Kahny-Simonius, J., Plattner, M., Schmidli-Vckovski, V., & Kronseder, C. (1998), 'Computer system validation: An overview of official requirements and standards', Pharmaceutica Acta Helvetiae, vol. 72, no. 6, pp. 317–325.
  3. Leveson, N. G. & Turner, C. S. (1993), 'An investigation of the Therac-25 accidents', Computer, vol. 26, no. 7, pp. 18–41.
  4. FDA (1987). Guidelines on General Principles of Process Validation. 
  5. FDA (1983). "Guide to Inspection of Computerised Systems (The Blue Book)". US Food and Drug Administration, Maryland, USA. 
  6. International Organization for Standardization, Geneva, Switzerland (1994). ISO 8402:1994: Quality management and quality assurance—Vocabulary. 
  7. "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". US FDA. 2002. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085371.pdf. 
  8. Weichel, P. (2004). "Survey of Published FDA Warning Letters with Comment on Part 11 (21 CFR Part 11)". Journal of Validation Technology 11 (1): 62–66. 
  9. ISPE (2008). "GAMP5: Risk Based Approach to Computer Compliance". International Society for Pharmaceutical Engineers, Tampa, FL.. 
  10. PIC/S (2004). "Good Practices for Computerised Systems in Regulated "GXP" Environments, Report PI 011-2". Pharmaceutical Inspection Convention, Geneva. 
  11. Smith, H. G. (2001). "Considerations for Improving Software Validation, Securing better assurance for less cost". Journal of Validation Technology 7 (2): 150–157. 
  12. Tracy, D. S.; Nash, R. A. (2002). "A Validation Approach for Laboratory Information Management Systems". Journal of Validation Technology 9 (1): 6–14. 
  13. Lucas, I. (2003). "Testing Times in Computer Validation". Journal of Validation Technology 9 (2): 153–161. 
  14. Balogh, M.; Corbin, V. (2005). "Taming the Regulatory Beast: Regulation vs Functionalism". Pharmaceutical Technology Europe 17 (3): 55–58. 
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