7 Tips to Hire a Top GMP Consultant

7 Tips to Hire a Top GMP Consultant

March 27th, 2013 // 10:36 pm @

Is GSK Pressure on FDA Exacerbating Hospira 483 Mess?

More Exclusive Expertbriefings News

Upcoming Expertbriefings

March 28, 2013

Due to all the layoffs in the pharma industry in recent years, we have seen a flood of new consultants in the pharmaceutical field. We’ve talked to quite a few experienced hands in the industry and this is what they tell us to do to hire the best GMP consultant:

1. Determine your scope of work before you even start looking for a GMP consultant.

I don’t know how many times I have heard of a big pharma company (hello, Hospira!) throwing a gaggle of GMP consultants at a compliance problem without fully understanding the product boundaries or what the expected results will be. This sort of thing happens a lot in the industry. It ends up being a frustrating experience for the consultant and the company, and a lot of money can be burned for no gain. I’ve heard that Hospira has thrown $100 million at GMP consultants in Rocky Mount NC and FDA still isn’t happy.

April 23 – $500K on Compliance or $300 Million on Consent Decree? Essential FDA Compliance Tips for Sr. Management

The formal scope of work document helps you and the consultant have a firm idea of expectations and to agree on essential assumptions that will determine the project’s success. A draft of the scope of work is something that can serve as a basis of discussion with your potential consultant. The final version of the SOW will be a formal, legal agreement that both parties can sign onto.

2. Determine what hard/soft skills are needed.

Consultants can do anything. Don’t believe it? Just ask them! Resumes are routinely inflated to give the impression that the consultant saved their last client from the FDA firing squad in Rockville. So, you are going to have to really explore what skills are needed for your GMP project, and ask very specific questions of your potential consultant to see if they really have the skills you need. Some skills may be hard, technical abilities, and others may be more of the soft variety that are important to get trust and buy in from your quality team. Always think, will my team’s skills be improved by working with Consultant X?

 3. They should be from industry.

FDAers are great, but it’s my view that it is better to hire a GMP consultant who has actually made drugs, and not just did inspections for 10 years. Of course, FDA experience is valuable because the client believes he’s going to get some insider information on a compliance issue. Or he thinks that they will get a better idea from a former FDAer of what FDA is after in the next audit.

The thing is, lots of people can tell you what’s wrong with your quality system. But there are a lot fewer who can offer reliable, cost-effective solutions to your quality problem.

Inspections are not a good measure of your company’s future performance. You want to find a GMP consultant that really understands all of the issues (operational, technical, cultural and social) that you need to consider when you are trying to fix a major GMP problem. Specific, experienced, and proven operational knowledge is simply irreplaceable in your GMP consultant.

4. Pass on consultants who have only worked in QA.

QA is very important, especially when you are putting together various elements of a QA system. But we remain a bit skeptical of a consultant who just has QA experience. There is no replacement for having solid operational experience to understand the environment in which GMP systems operate in a drug company. If the quality system is not practical and easy to use, the employees are going to find workarounds that are, and that can mean big trouble come inspection time.

Delve into the operational experience of a prospective consultant. Ask how his or her operational experience has turned them into a better consultant.

Last point on this – We find there is little worse than a consultant with decades of QA experience only, and in one company. Pass!

5. Do not write off a consultant for one failure.

There are good consultants out there who failed in their career. Or, it might look like a failure in your eyes, or feel like it to that consultant. The fact is that people get fired for improper reasons all the time. Sometimes people are fired for standing up against an organization for doing something wrong. Also, there are older consultants who were let go because of layoffs.

Some may disagree, but consider hiring someone with a history, or someone who had a failure in the past. It’s really not unusual. We think it would be better to take someone with an isolated failure, compared to a QA-only consultant who worked in the same place for 30 years.

6. Stay engaged with the consultant and keep ownership of your GMP problems.

Some pharma companies in deep trouble with FDA bring on a consultant the same way they bring in a contract manufacturing partner. You cannot subcontract your GMP issue to someone else. In the eyes of FDA and the public, you are accountable for the end result. If you end up whining to FDA about how a consultant screwed you, you’re going to get no sympathy.

The consultant and the client firm need each other, so it is vital to stay in good communication. Management can’t usually solve a major GMP issue without some consultant help, but the consultant can’t do it all by herself. Often the problem with a GMP issue hinges upon larger issues surrounding company culture and leadership. The consultant needs to be able to talk to the company about this and vice versa.

7. Don’t make the oversight too complex.

Consultants often work in project teams that are made up of client owners and SMEs. There needs to be oversight by management, but the project teams need to keep their focus on the matter at hand. You should not waste their time and focus by having them doing constant Powerpoint updates and admin work to keep multiple managerial layers informed.

If you want to learn about what senior management can do to improve quality and compliance, take a look at our upcoming compliance webinar for senior managers.

 

 


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner