Seqens eBook - 18

CROs

5.

How well has the CRO correlated the disparate information it
has created to provide a cohesive, consistent data package?

6.

Has the CRO produced a set of data or has the CRO taken that
data and converted it into useful and actionable information?

The answers to such questions can only be obtained if the CRO has actually
performed the activities required in an E&L study. If these activities are
not performed in the context of a real study, then the activities may be
performed as part of an artificially-created competency evaluation. There
are three possible formats for such an evaluation:
1.

The CRO is provided a well-characterized reference material
(that is, a material with a previously established extractables
profile), and asked to determine this material's extractables
profile.

2.

The CRO is provided with an "artificial" extract of known
composition to evaluate (for example, a solution prepared
in the laboratory containing known compounds at known
levels).

3.

The CRO is provided with an extract that the contracting
laboratory has characterized for extractables using its own
methods and laboratory.

Regardless of the format of the competency evaluation, the success of
the CRO is judged primarily by the accuracy and completeness of the
extractables profile it generates. Secondarily, the CRO is judged for the
means it utilized to obtain the information contained in its evaluation
report. For example, the means by which the CRO elucidated the identity
or estimated the concentrations of extractables in a test sample may be

to both parties to have reached this milestone in their relationship
and there will be enthusiasm to begin meaningful, valuable, and
complex work. However, before the CRO and contracting laboratory
begin performing real studies, it is useful to debrief in terms of the
whole screening and qualification process. Debriefing serves as an
opportunity to review the issues that came up during these processes
and to make sure that any actions taken to address potential issues

as significant an indication of its technical savvy as its actually obtaining

were properly conceived and effectively implemented. If circumstances

the correct answer.

allow, it would be sensible to use a study of moderate importance and

It is difficult to establish objective acceptance criteria for the competency
evaluation upfront, as the criteria depend somewhat on the nature and
the complexity of the evaluation. If the evaluation consisted of analyzing
a test sample containing a reasonable number of commonly encountered
extractables at challenging (but not impossible) levels, then it may be
appropriate to use the most stringent acceptance criteria which is that
the CRO found all targets, correctly identified the targets, and properly
estimated their concentrations. On the other hand, if the evaluation
involves testing an actual material, it is unreasonable to expect that the

complexity as the first study conducted within the partnership. In
doing so, both the CRO and the contracting organization are provided
with the opportunity to build a solid foundation of success and likely
avoids the trauma (and drama) of having to navigate the challenges
inherent in the more complex E&L assessments.

References
1. Insights Gained into the Identification, Qualification and Utilization
of CRO Laboratories in Extractables and Leachables Studies. D. Jenke.

CRO will produce the exact same profile that the contracting laboratory

(Pharmaceutical Outsourcing, Vol. 14 Issue 2).

would generate. While one should expect reasonable inter-laboratory
agreement for the major extractables, there may be significant differences

2. Compatibility of Pharmaceutical Solutions and Contact Materials:
Safety Assessment of Extractables and Leachables for Pharmaceutical

in the results obtained for the more minor extractables. Rather than

Products. D. Jenke. (Wiley, New York, 2009).

serving as reasons to eliminate a candidate CRO, such differences can lead
to mutually-beneficial discussions between the CRO and the contracting

3. Leachables and Extractables Handbook: Safety Evaluation,

organization.

Qualification, and Best Practices Applied to Inhalation Drug Products.

STEP 4: Implementing a Qualified CRO
as a Partner

D.J. Ball, D.L. Norwood, C.L.M. Stults, L.M. Nagao, Eds. (Wiley, New
York, 2012).
4. Update on Undertaking Extractables and Leachables Testing. A.
Feilden, (Smithers Rapra Technology, London, 2011).

After the selection and qualification of a CRO partner is complete, both
the CRO and the contracting organization look forward to designing

5. Norwood, D.L. Considerations for outsourcing of leachables and

and implementing their first collaborative study. It will be gratifying
Pharmaceutical Outsourcing |

extractables testing. Am Pharm Outsourcing, 9(2): 22 - 28 (2008).
18

| pharmoutsourcing.com



http://www.pharmoutsourcing.com

Seqens eBook

Table of Contents for the Digital Edition of Seqens eBook

Contents
Seqens eBook - 1
Seqens eBook - Contents
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