Selecting a Laboratory for Pharmaceutical Stability Testing
By: Katherine Robertson
Edited by Melissa Reeves
Because stability testing must be performed to the standards of the FDA and other government agencies, the protocols are rigorous, the procedures are highly regulated and both staff and equipment are quite expensive. As a result, fewer pharmaceutical companies and contract research organizations (CROs) have integrated stability testing capabilities and more are turning to comprehensive analytical laboratories such as Impact Analytical for this and other testing services. Stability testing can be performed as part of a larger Extractables/Leachables program, or as quality testing of a drug product and drug substance to determine shelf life. While many laboratories can offer selective services, the best arrangement for many CROs, pharmaceutical and medical device companies is to partner with a laboratory to provide stability testing services on an ongoing basis. Over time, our personnel become familiar with your staff, products and procedures and can provide you a seamless and cost-effective resource. When selecting a laboratory for pharmaceutical stability testing, look for a partner with significant experience evaluating many different material types, with a complete range of testing environments, and the most advanced analytical equipment.
The Testing Process
The purpose of stability testing is to determine the overall stability of a drug substance or analyte. Method development may be required to characterize possible degradation products and determine conditions for the stability testing. These conditions should include the effects of temperature, humidity or other means of stress upon the pharmaceutical product. The final method used to analyze the test material and degradants should be a validated method, establishing such parameters as linearity, limits of detection and quantitation, robustness, accuracy/recovery and precision. With advanced equip-ment and techniques such as gas or liquid chromatography and mass spectrometry, researchers can characterize the API, impurity, or other analyte with an extraordinary degree of accuracy. Any observed alteration in an analyte may be an indication of degradation. The stability testing is performed under a protocol agreed to by the testing lab and the sponsor, and that also meets federal guidelines. Accelerated degradation testing that follows established guidelines may also be used; this involves stressing the pharmaceutical product by means of higher temperature and humidity. Analysis of the drug substance or analyte is performed at regular intervals according to the protocol, and at the conclusion of the study, a final report is prepared and submitted it to the sponsor.
|What to Look For in a Lab
For all intents and purposes, these are
the procedures that are followed in
virtually every stability testing
laboratory in the country. To be an
effective stability testing partner,
however, a lab must be held to a
|Secure and Regulated Storage
For longer-term studies, the laboratory
will need secure storage facilities that
can maintain environmental conditions
without interruption over the course of
several years, including deep freeze
and variable temperature and humidity
stability chambers. These systems
should be monitored continuously with
|Start With the Scientists
Look for a laboratory with a staff with
a high proportion of master’s and
doctoral degrees in fields specifically
related to chemistry and pharmaceuticals.
For consistent, high-quality results, seek
scientists and technicians trained and
experienced in the specific procedures
required by your testing needs.
|Beyond Stability Testing
An effective laboratory partner will also
be able to provide for laboratory needs
that go beyond just stability testing and
may include material characterization,
methods development and release testing,
in addition to regulatory consulting. Impact
Analytical, for example, maintains facilities
and equipment for a full range of analytical
testing, including elemental analysis, gas
separation, liquid separation, molecular
characterization and thermal/mechanical
To be of any real value, a stability
testing laboratory must be compliant
with cGMP and GLP standards and
operate in accordance with guidelines
established by the FDA and the
International Conference on Harmonisation.
Verify current certification by CLIA
or other regulatory bodies.
For the best outsourced relationship,
seek a laboratory that excels at communication
and customer service and actively encourages
a partnered relationship. Look for an atmosphere
that encourages a team approach between the
company and the laboratory. In addition to
these qualities, Impact Analytical also has in
place a Project Coordinator, whose role is to
facilitate information and customer service.
|Formalized Quality Assurance
To satisfy government protocols, data
collection must be documented and verified.
A laboratory that provides a rigorous quality
assurance program to audit both research
and reports will give peace of mind to sponsors
and regulators alike.
|An Integrated Capability
Equally important or perhaps more importantly,
using a specialized analytical testing laboratory
brings focused expertise, innovative solutions
and new techniques to the table. Additionally,
a singular focus often means you’ve attracted
the best experts in a variety of scientific
disciplines. Ultimately, the focused analytical
capability of an analytical laboratory means
better science. And, in the end, better science
means better products.
Look for a laboratory that keeps facilities and
equipment up to date, including the latest
technology in mass spectrometry, molecular
characterization, gas and liquid chromatography,
and inorganic spectroscopy.