BioPharm: Specialty laboratories, such as those that test and release the drug substance or drug product that is biohazardous or produced
in a sterile process, face unique challenges. The ISPE guide includes a section devoted to these complex laboratories. How
do quality teams have to adjust their approach when working with these types of laboratories and facilities?
Berg: This is an interesting and very complex area. The guide does address several types of specialty laboratories, including aseptic
and sterility test laboratories, biohazard laboratories, and potent-compound laboratories. Each of these laboratories has
unique design challenges and regulatory considerations, and so it's difficult to make generalizations about this section.
Depending on the size of the sample, many of the special conditions can be accomplished in isolators or biohoods, especially
if the sample is closed and only opened for testing in small quantities. Other areas of concern are the handling of solvents
within the laboratory and their removal as waste products from the laboratory. Solvents play a large role in testing, and
making sure that explosion hazards as well as fire hazards are mitigated is critical. The law allows fixed quantities of solvent
within the laboratory, so the design aspect of this is critical to its ongoing operation. In general, however, I'd point those
interested in this topic to the content of the guide, which contains much more detailed information than we can go into here.
BioPharm: The ISPE guide devotes a section to record management and recommends that each laboratory develop an operations manual to
identify potential hazards, along with practices and procedures to be followed to minimize or eliminate those hazards. Do
today's bio/pharmaceutical quality laboratory teams tend to have such manuals, and do you think they will be inclined to have
them going forward?
Berg: While it's always difficult to predict the future, I think it's safe to say that the industry will have some form of risk-based
documentation, particularly in light of ICH Q8, Q9, and Q10. Because the quality laboratory handles a variety of products,
raw materials, and solvents, there is a definite need for standard operational procedures. There is also a need for documented
proof that a training program is in place to make certain that the seasoned scientist and the support staff are fully aware
of the hazards surrounding their operation and that the devices within the laboratory are used appropriately. The goal is
to minimize the risk of these hazards, both to the scientist and to the sample. Besides training and operational procedure,
the quality laboratory should be equipped with a validation system on maintaining records of the testing performed, which
is the basis for the release of product to market.
BioPharm: The guide includes an appendix for key differences to consider in European-based bio/pharmaceutical laboratories. Were FDA
or EMA officials involved in reviewing the guide before its publication, and do they support its recommendations?
Berg: Fortunately for ISPE, both agencies were involved in the review process of the guide, and their feedback was incorporated
in the final draft. It's not typical for regulatory bodies, such as FDA and EMA, to endorse or tacitly support industry guidance–
and it's not their role to do so. That being said, I think it's fair to say that having their input during the review process
has helped the guide to be reflective of current regulatory thinking from both agencies on this subject.
BioPharm: In general, based on this new guide, what key differences do you and ISPE hope for in the bio/pharmaceutical quality laboratoryof
Berg: Ultimately, ISPE hopes that this guide will provide quality laboratory facilities with the necessary risk-based tools to
support the release of high-quality pharmaceutical products to patients.