Cleaning Validation Requirements in Asia

Recommendation

15/16 February 2024

Process Understanding - Live Online Training
Statistical Process Control (SPC) as a tool to get there

Since the nineties, cleaning validation has been one of the main validation topics discussed by the pharmaceutical industry and APIs manufacturers. Because of growing globalisation, countries in East Asia (Tiger States and Panther States) have also become interesting as consumer countries of APIs and/ or medicinal products. What about requirements on cleaning validation there?

On Singapore's Health Authority site you can find a "Regulatory Guidance" from the beginning of 2013 which specifies the requirements on cleaning validation.

What's new?  How similar or different is this guideline from other European or US guidelines on cleaning validation?

The good news is that there are practically no significant differences. The content of the guidance refers entirely to the PIC/S document PI 006, see PIC/S website. Annex 15 of the EU GMP Guide is based on the former version of the PIC/S document PI 006. It also covers the requirements of the Guide to Inspections on Cleaning Validation of the US FDA.

In a word, the taking over of passages from the PIC/S PI 006 document about cleaning validation makes Singapore's requirements directly comparable to the European and US ones.

The guidance document can be found on Singapore's Health Sciences Authority website.