International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (2012) ICH Q11: Development and Manufacture of Drug Substances (Chemical and Biotechnological/Biological Entities). ICH.

has been cited by the following article:

• TITLE: Cleaning Validation: Analytical Strategies and Practical Implementation Using Chromatographic Methods

  AUTHORS: Sai Krishna Bompelliwar, Kishore Raju Vatsavai, Jayaram Kamma, Anil Kumar Ramgiri, Ravi Teja Meduri, Kishore Kumar Hotha

  KEYWORDS: Analytical Cleaning Validation, MACO Limits, ICH, and FDA Guidance

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.17 No.3, March 30, 2026

  ABSTRACT: The cleaning validation is the most important step. Cleaning validation is a crucial aspect of pharmaceutical manufacturing to ensure that residues from previous batches do not contaminate subsequent products. This review explores the principles, regulatory requirements, analytical techniques, validation parameters, challenges, and future trends associated with cleaning validation. The focus is on ensuring compliance with Good Manufacturing Practices (GMP) while maintaining product safety and efficacy. This review paper provides a comprehensive review of analytical method cleaning validation procedures.