Q&A with Gibraltar Laboratories

PharmTech:

What is the biggest industry challenge you're now facing?

Prince

The biggest challenge that our industry faces is uncertainty about the economy. Because labor is less expensive overseas, manufacturing and administrative jobs are being lost in America to foreign competitors. Furthermore, because businesses are being overtaxed and overregulated, our home-based companies are at a competitive disadvantage.

PharmTech:

How do you stay abreast of new developments in the industry?

Prince

I stay current by doing a lot of reading and getting out to meet my customers and colleagues. I am also inviting other successful laboratories to share best practices.

One of our best practices is offering our own legal documents such as confidentiality agreements and audit procedural agreements. This initiative allows us to schedule audits quickly because legal review, if any, is not as necessary. Having 1000 audits per year by 1000 customers, all of whom have their own confidentiality agreements, is a burden and mostly wastes valuable time and legal resources.

PharmTech:

Do you see a new industry trend emerging?

Prince

We are committed to rapid testing techniques. New alternatives to some classical microbiological tests are available, and they can save one to four days. We are educating our customers about the advantages and disadvantages of these new microbiology rapid techniques.

We have invested in fluorescent and kinetic instruments, but we have not decided yet what our next steps will be. We would be interested in a rapid sterility test. The risks of rapid technologies are that they are expensive and require reliance on a sole source for supplies and repairs. The advantages of existing US Pharmacopeia microbiology methods are that they are affordable and can be performed by laboratories all over the world, including in developing countries.