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Specialty Chemistry Forums => Other Sciences Question Forum => Topic started by: Alki on January 12, 2012, 06:06:22 PM

Title: Validation Guidance for non-pharmaceutical analytical methods
Post by: Alki on January 12, 2012, 06:06:22 PM

I know the Guidance for validate analytical methods, and I see that are focus to pharmaceutical products, but Do this guides apply to analytical methods not related to pharmaceutical products? ???

Title: Re: Validation Guidance for non-pharmaceutical analytical methods
Post by: discodermolide on June 01, 2012, 03:22:26 AM

Quote from: Alki on January 12, 2012, 06:06:22 PM

I know the Guidance for validate analytical methods, and I see that are focus to pharmaceutical products, but Do this guides apply to analytical methods not related to pharmaceutical products? ???

These guidelines will be used for any substance that is produced and analysed under GMP conditions and will be sold for use after official approval.

Title: Re: Validation Guidance for non-pharmaceutical analytical methods
Post by: Arkcon on June 01, 2012, 08:17:36 AM

The are other standards.  The validation standards applied to pharmaceutical products fall under the heading of cGMP, sometimes called GMP (Good Manufacturing Practices) of QSR (Quality Standard Regulation.)  I believe there are similar, but different standards, for environmental testing.  Also, sometimes NIST (National Institutes of Sciences and Technology) traceability is adequate, say for fine chemical manufacturing.  I've also worked under Six Sigma for fine chemicals manufacturing.  The question you have to ask is:  if you're not making a medicine (or a food, or a cosmetic,) or you're not testing an environmental sample for compliance with a government requirement, or you're not testing a manufacturing sample to confirm for a customer that the quality is consistent and adequate for their application -- what are you testing?