Dear Pharma Pals,

Yet another pharmaceutical industry global expert writes for us in our exclusive on cleaning validation. Igor Gorsky’s accomplishments over the 40 years and more include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion-dollar drug product lines and introduction of new products onto the market. He has published numerous articles and white papers in pharmaceutical professional magazines and textbooks.

Igor Gorsky writes on cleaning validation scenario globally and in India, how serious and compliant are pharmaceutical manufacturers on this ongoing task, the need for science and risk based approach, the regulatory expectations and standards, cleaning agents and processes, analytical methods used for cleaning validation, and how to build a robust cleaning validation process.

In the past, the Indian manufacturers used to have issues with cleaning processes due to very rapid introduction of many products, manual cleaning practices, poor documentation, and overall issues with not understanding cleaning validation basics,

In Igor Gorsky’s assessment the cleaning validation programs in India are greatly improved now. Most of the companies in India now utilize science and risk-based approach to cleaning validation which means that they are using toxicological assessments to determine safe exposure limits which in turn used for establishment of a science-based cleaning validation specifications.

However, he says, one area of the considerable concern stands out is development of the cleaning process. A typical Indian manufacturer rarely develops a cleaning process and typically uses local cleaning agent manufacturers or providers of re-used cleaning solvents for cleaning programs.

The most important recommendation Gorsky makes is to establish a Cleaning Validation Ownership and appoint a manager with considerable level of authority to oversee this function from all three stages of validation: Design and Development, Cleaning Process Validation, and Continued Verification.

Also read with our cleaning validation exclusive, Dr. Tim Sandle’s article on the application of good hygiene design techniques to achieve the required hygienic state.

Harjit Singh Dhaul
Publisher & Editor

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