• Institute of Good Manufacturing Practices India
  • Global accredited training & certification provider
  • Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India
  • Approved Training Institute of Food Safety and Standards Authority of India (FSSAI)
  • Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India
  • An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India
  • Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
  • Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC) set up by National Skill Development Corporation (NSDC)
  • Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD & ASSOCHAM Services Excellence Award 2017

Trusted by organizations & training participants in over 30 countries
Training | Certification | Education | Research

Missing Lifecycle is criticized by FDA in Process Validation

Updated: 27 March 2019

The FDA recently published a warning letter stating the deficiencies related to process validation. Own process validation process was not followed by the company to validate major changes. On further response by the firm, FDA says that several things were still missing such as program details illustrating the maintenance of validated process, process performance qualification plan.

The FDA has also stated process validation as lifecycle process which starts with product development and should be considered throughout the lifecycle. Therefore, it can be concluded that the FDA also checks the implementation of process validation as lifecycle model.