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

WHY  VALIDATE? 

The simple answers:  "It's the law." "The CGMPs require it." 

The real answer:  Yes it's the law, and the CGMPs require it.  But let's look beyond such negative motivators. 

Consider the real purpose of V&V. Not to satisfy a reg or audit, tho that's what motivates many. The real purpose is to prove that whatever you're verifying and validating (V&V) does what it's required to do, why it was acquired and installed (requirements)? That requires that before you spend time on other V&V activities, you verify (inspect, test, check, qualify) that it is installed properly, i.e., all applicable manufacturer's requirements have been met (electrical voltage, current, grounding, air exhaust, air treatment, safety, environmental prep, and so on). If this isn't done first, then subsequent V&V activities are compromised. 

If some process or equipment may have been running for X years, and will be retroactively validated, it's safe to assume that it's installed properly. However, "assume" is not in the QMS (Quality Management System) vocabulary, so even with an established system, some checks must be performed (IQ), and all QMS' require documentation of that activity. You may do so and find some problems which will have to be addressed. Then you can progress with verifying and/or optimizing the settings used (DOE may be involved), whether you call it an OQ or not. Then you challenge the system repeatedly with all the extremes of allowable inputs (material, personnel, times of day, utilities fluctuations, etc) to show (whether you call it a PQ or not) that the system being V&V is robust and will virtually always deliver expected levels of quality with known and acceptable levels of variation (see recent drug process validation guidance from FDA), which will change / improve over time / lifecycle. These should be done, as needed, all or part, over the life time of the product / process / equipment involved. 

-- John E. Lincoln, J. E. Lincoln and Associates LLC; jelincoln.com