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Seven Success Criteria for Hiring (and Working with) a GMP Consultant

You cannot subcontract your problems

The QA Pharm
Mon, 04/16/2012 - 10:38
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The high layoff numbers in the pharmaceutical industry and poor job prospects in a weak economy have flooded the market with would-be consultants to pharma companies that need extra help. Here are my suggestions for hiring and working with an experienced good manufacturing practices (GMP) consultant.

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1. Define the scope of work before you start scouting for a consultant.

There is nothing worse than throwing a bunch of consultants at a problem without knowing the boundaries of the project or defining the expected results. Unfortunately, it happens all the time. It ends in frustration for all parties involved, and the tragedy is: Nothing gets better.

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Submitted by Vijay Ruikar on Wed, 04/18/2012 - 18:27

On Hiring a Good Consultant

I read with great interest the criteria the author spells out for hiring a good consultant. I respect his opinion. However, here are some other perspectives, from the view point of a manufacturing engineer who has become a QA consultant. They are applicable to all industries, including, and especially, the pharma industry which has often manufacturing done overseas, whose raw materials also come from yet further removed overseas/US domestic suppliers.

1. Scope of Consultancy: While nothing is better than a well-defined consultancy project, practical realism makes it obvious that such "balck and white" clear delineation of the scope of a consulting project is rare, in any field. What seems to be more applicable is that a general area of consultancy should be defined, identifying the sub-topics. Deadlines or expected goals should also be defined, as well as the terms of compensation.However, there, the definition of the scope stops, since the goals to be achieved, often prove to be a target that is moving farther and farther afield. So, a fixed definition of the scope leaves the consultant with limited responsibilities- the company who hires him suffers.

2. Knowledge of QA: There is no such thing as a "pure" manufacturer, these days. What this means is, every manufacturer, (and yes, especially the "pharma" and "food supplements manufacturer") buys his raw materials and partially processed materials from some set of suppliers. Given this indisputable fact, having an efficient inspection and QA process is the logical, and mandatory first step to ensure quality in the finished products. First hand knowledge of Quality Assurance, Inspections, Acceptance Sampling, tests on selected samples, and day-to-day hands on experience in accepting and rejecting lots supplied by raw material providers is thus, crucially important. Also, first hand knowledge of accreditations required for testing labs, inspection agencies and certification bodies, is indispensable.  FDA inspectors who are knowledgeable, and/or any QA professionals (especially with ASQ-Certifications) who are proficient and with experience in these areas, are worth their weight in gold, in pharma and food supplement manufacturing. With all due respect, it would be nothing short of hazardous to assume that mere knowledge of manufacturing, however "first hand", can address this situation.

3. Communication, Skills plus soft/hard skills: It goes without saying that by definition, a consultant must have excellent proficiency in getting the "buy-in" for his ideas at all levels , from top management, down to the line operators. Thus, ability to communicate, through Powerpoints, phones, e-mails, and plain old word of mouth, so as to get the bset cooperation from the people, is a mandatory requirement.

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