PharmTech: Who should be aware of the principles stated in USP ‹1117›?
Sutton: The principles stated in USP ‹1117› are important for the integrity of the data coming from the QC microbiology lab. All personnel working in that laboratory
should be familiar with these principles, as should the QA unit responsible for reviewing the data and auditing the lab. It
should also be noted that internationally regulatory agencies are certainly familiar with this chapter, and so all those responsible
for product submissions, regulatory inspections and relationships with those agencies should be aware of current expectations.
PharmTech: Why is training, particularly of supervisors, such a concern in this chapter?
Sutton: You would like the situation to be that everybody in the microbiology laboratories work for people who are well-trained
and academically trained microbiologists. Unfortunately the common situation in a lot of laboratories is that the person who
heads up the microbiology laboratory may have not have any training in microbiology at all. And that is reflected in how the
laboratory operates. You can't run a lab the way you run a chemistry lab. Microbiology labs should be headed by someone who
really knows the scientific discipline, not only for the confidence you have in the results but also the fundamental biosafety
requirements. The biosafety manual published by the Centers for Disease Control requires all Level 2 laboratories to be led
by a microbiologist who is able to set safety rules and guidelines. But in the industry today, this is not true for many microbiology
laboratories. So this provides a minimal set of requirements.
PharmTech: What other situations in the industry has created a need for this chapter?
Sutton: I would refer you to a recent publication by Luis Jimenez (J. Jimenez, "Microbial Diversity in Pharmaceutical Product
Recalls and Environments," PDA J Pharm Sci Tech.
61 (5), 383-398 ). He published an interesting retrospective on recalls over the past years looking at both sterile and
nonsterile product recalls. There are a large number of those recalls from the smaller pharmaceutical companies. It should
be noted that some companies do not have a microbiology department at all and send all microbiology testing out-of-house for
testing. The danger in this approach is that the company fails to develop the in-house expertise in microbiology, and may
run risks that other companies might avoid. The quality of safeguarding the finished product has a large, and a critical microbiology
PharmTech: What are the revisions that need to be made?
Sutton: There have been a couple of gaps that have been identified in the chapter that should be corrected. One deals with
sample handling and transport, which is especially useful for samples going out to contract laboratories. There is nothing
in the chapter right now that discusses how to collect samples for shipping and transport, how much time is permissible between
sample collection and sample testing. These issues should be addressed. Additional information needs to be included on equipment
(especially lab autoclaves) and on laboratory resources. In addition, the section on supervision of the laboratory may also
be strengthened, depending on the comments we receive after the publication in the Pharmacopeial Forum. So we are hoping those in industry will be active in this ongoing revision process.