Strategies for Cleaning Validation in the Manufacture of Pharmaceutical Products
- Tuesday
- August
- 12
- 2025
Dr. Ganesh Prasad Overview
The lecture covers implementing a cleaning validation program based on risk approach. Higher the risk, more rigorous should be the cleaning procedure and should be validated. The discussion covers different levels of cleaning required in different situations and a methodology to assess the risks of cross contamination. Strategies to fix cleaning limits and various test methods as well as sampling techniques to detect residues will be discussed. grouping strategies may be discussed if time permits.
Why you should Attend
Cleaning of pharmaceutical manufacturing equipment's and tools is very critical to prevent cross contamination of products. Many regulatory citations have been due to inadequate cleaning and more importantly demonstration of adequate cleanliness. Hence it is essential that concerned personnel shall have a good understanding of implementing a cleaning program which is fit for the purpose and comply with regulator’s expectations.
Areas Covered in the Session
- Cleaning to prevent of cross contamination
- Criticality of cleaning based on risk
- Calculation of cleaning limits
- Sampling and detection methods
- Examples
- Dirty hold time and Clean hold time concepts
- Validation protocols
- Grouping strategies
Who Will Benefit
- QC Analysts
- QA chemists and R&D and analytical R&D chemists
- Personnel from production Tech transfer
Speaker Profile
Dr. Ganesh Prasad is a freelance Pharma consultant in India under the banner ‘Q_Pharma consulting India & holds a doctorate degree in Organic Chemistry from Indian Institute of Science, Bengaluru. Previously, he worked at senior levels in pharmaceutical companies like Apotex Pharmachem India Pvt Ltd, ICI Pharmaceuticals, India and other organisations heading QA/QC/Process functions. He has also worked as scientist in the US FDA laboratory in Washington and other reputed institutions in USA/ Canada/India. He has together more than 30 years of experience together in quality assurance function, research in academia and industry. As a consultant he has assisted many pharmaceutical companies towards establishing cGMP standards of US FDA, European and Indian regulatory agencies. He also conducts third party quality audits of pharmaceutical manufacturers. He has conducted many public and in-house workshops and delivered invited lectures in forums like UBM, ISPE, DIA and so on.