Cleaning validation in non-sterile pharmaceutical manufacturing is moving towards a risk-based approach. This is a significant change in all aspects for the industry. In this presentation we will summarise the global regulatory guidelines leading to all the changes for cleaning and its validation within the pharmaceutical industry. Included in the review will be the guide to inspection of cleaning validation from the FDA, as well as ICH-Guidelines Q7A and Q9 and the ASTM E3106-18 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation. Further, the guidance documents from ISPE – Cleaning Validation Lifecycle – Applications, Methods and Controls and the Pharmaceutical Inspection Co-Operation Scheme document PIC/S PI 006-3 as well as Annex 15 of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use will be discussed. The main objective of this presentation is to enable understanding of the regulatory landscape and the detailed requirements from regulatory guidance documents that relate to the risk-based cleaning validation approach


Thomas Altman:  Thomas is a cleaning chemistry, cleaning process, cleaning validation and regulatory compliance subject matter expert.

He is an expert in cleaning validation for product contact surfaces across all types of pharmaceutical and personal care production equipment. He is experienced in addressing regulatory inspection findings related to cleaning processes – and with implementing CAPA plans to prevent re-occurrence. Thomas has developed more than 1500 cleaning programs/ recommendations for pharmaceutical and personal care industries. Thomas contributed significantly to the ASTM E55 WK15778 Cleaning Process Development and Validation standard and published related articles as a co-author in “Pharmaceutical Engineering” as well as “Pharmaceutical Online” and “Biotechnology Online”. Prior to joining Ecolab, Thomas worked in the pharmaceutical and food industries.