CROSS  POLLINATION


The US FDA, in its publications and/or on its website, fda.gov, provides much industry-specific material, guidance, and tools.   Why not look outside your own industry.

In my webinars and workshops, I tie my recommended "working" V&V definitions to CGMP and ISO requirements as a start.  Same applies to guidance docs and standards.  These list either legal requirements or recommendations, but require additional / working definition to make them usable, defined in SOPs ... and to be followed by the company.  In doing so, I  have not yet ever had push-back from an FDA or ISO/N-B auditor.  

I also always look at other regulated industries for the "C" [current] in CGMP.  The FDA agrees --  note their introduction to Process Validation, Jan 2011 (for pharma, BUT ...), especially the last sentence below:

"This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes."

Check the FDA's website, fda.gov, and enter validation or validation guidance or validation guidelines (also add software...)  in the upper right search box, and follow the leads, pulling out points that are of value, no matter what the industry.


In my webinars and workshops, I also mentioned QSIT (devices), ICH Q-series (pharma) and HACCP (foods) as all containing points that could be used in other regulated industries.

Be comfortable in "looking outside the  box" in adding the "C" to your "GMPs".  

-- John E. Lincoln