Mass spectrometry for biopharmaceutical characterization, regulatory compliance Contribution from Ileana written on 8/30/2010 at 15:22
Dear all
I am interested in Biopharmaceutical Characterisation by Mass Spectrometry , and I would like to ask you, in order to lighting up my mind, about how to help smooth the path, particularly through the regulatory approval stages, for protein characterization and stability studies (impurities profile) as indicated in ICH Q6B, for example
1- How to handle Out of Specifications results in mass spectrometry characterization? As FDA guide or there is a more simple approach?
2- What is the laboratory standard GLP (Title 21: "Food and Drugs" of the Code of Federal Regulations (CFR) as Part 58: "Good Laboratory Practice for Nonclinical Laboratory Studies,” or GMP (21 CFR chapters 210 y 211 dedicated to drug)? Because the first one is the easiest from my point of view?
3- Can you recommend me some point to consider or guideline for mass spectrometry quality assurance?
With regards
MSc Ileana Rosales
Pharmacist GEBC
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