To Comply, or Not to Comply

I contact many, many companies every month.  I am so concerned for them as they just don’t understand what the GMPs are or how to comply to them.  They tell me, “We are handling that internally,” or “We have ??? Certification.”  I like to ask them, “Has complying with the GMPs helped your bottom line?”  Most say, “Of course not.”  My reply then is that they are not doing something right.  GMPs are simple.  It’s like building the foundation of a house.  If you build a house with a weak or no foundation, you will find yourself spending a lot of time repairing the cracked walls, roof, plumbing, etc.  But, if you built it on a strong foundation, those little problems disappear.  If you build a strong foundation of GMP compliance for your company, you will not experience all the little problems that come from having a weak foundation.  Output will increase and profitability will as well.  My job is to provide a strong foundation of GMP compliance so companies can profit utilizing my integrated SOPs, Forms, and Templates.  I’m different from most consultants as I actually do the work for my clients.  If they implement my “Process Control System” (Section H of 21 CFR 111), they not only exceed the GMP requirements, they actually gain efficiency never experienced before.  The icing on the cake… I perform a thorough FDA style audit and issue a GMP certificate recognized worldwide.  Unlike some other agencies that have never produced a product in their life.  My clients have never received so much as a 483 from the FDA once certified.  The other guys can’t say that.