Chromatography Forum

Hi All

We need to perform a method validation on an Assay for a drug product. The formulation is relatively straight forward.

The drug substance is dissolved in water and then pH adjusted to 4.5 - 5.5 with 0.1M Hcl. Once pH adjusted, the solution is made up to volume. Currently, drug product is not available for us to perform the method validation.

Since this is a simple formulation, would we be able to make a lab scale batch and use this to validate the Assay method?

Regards
Michael

Detail which regulatory body your product will fall under. Like South Africa only? EP? USP?

Are you purchasing the drug substance from official source with a certificate of analysis?

Hi

Thanks for your response. The drug substance is being purchased from the registered API manufacture. i.e. the same API that will be used in the DP.

This product is registered in South Africa and EU. The reason for making our own lab scale sample was because the DP was not available in the market. There was a shortage due to the pandemic.

Thanks again for your response.

Regards
Michael

I think that you would be well-advised to send out a sample of your in-house manufactured DP to an independent lab for analysis that would come with a certificate of analysis.

Regards,
JMB

I think that you would be well-advised to send out a sample of your in-house manufactured DP to an independent lab for analysis that would come with a certificate of analysis.

I'd think that such independent lab would need to be experienced with such analysis, and also "vetted" for cGMP or similar compliance by your QA department.

Thanks JMB and Consumer Products Guy for your suggestions. I will explore this option.

Regards
Michael