Subcontracting of testing 93 when a laboratory

Subcontracting of testing
9.3 When a laboratory subcontracts work, which may include specific
testing, it is to be done with organizations approved for the type
of activity required. The laboratory is responsible for periodically
assessing the competence of a contracted organization.
9.4 When a laboratory performs testing for a customer and subcontracts
part of the testing, it should advise the customer of the arrangement
in writing and, if appropriate, gain his or her approval.

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9.5 There should be a written contract which clearly establishes the
duties and responsibilities of each party, defines the contracted
work and any technical arrangements made in connection with it.
The contract should permit the laboratory to audit the facilities and
competencies of the contracted organization and ensure the access of
the laboratory to records and retained samples.
9.6 The contracted organization should not pass to a third party any
work entrusted to it under contract without the laboratory’s prior
evaluation and approval of the arrangements.
9.7 The laboratory should maintain a register of all subcontractors
that it uses and a record of the assessment of the competence of
subcontractors.
9.8 The laboratory takes the responsibility for all results reported,
including those furnished by the subcontracting organization.
Part two. Materials, equipment,
instruments and other devices
10.
Reagents
10.1 All reagents and chemicals, including solvents and materials used in
tests and assays, should be of appropriate quality.
10.2 Reagents should be purchased from reputable, approved suppliers
and should be accompanied by the certificate of analysis, and the
material safety data sheet, if required.
10.3 In the preparation of reagent solutions in the laboratory:
(a) responsibility for this task should be clearly specified in the job
description of the person assigned to carry it out; and
(b) prescribed procedures should be used which are in accordance
with published pharmacopoeial or other standards where
available. Records should be kept of the preparation and
standardization of volumetric solutions.
10.4 The labels of all reagents should clearly specify:
(a) content;
(b) manufacturer;
(c) date received and date of opening of the container;
(d) concentration, if applicable;
(e) storage conditions; and
(f) expiry date or retest date, as justified.

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10.5 The labels of reagent solutions prepared in the laboratory should
clearly specify:
(a) name;
(b) date of preparation and initials of technician or analyst;
(c) expiry date or retest date, as justified; and
(d) concentration, if applicable.
10.6 The labels for volumetric solutions prepared in the laboratory should
clearly specify:
(a) name;
(b) molarity (or concentration);
(c) date of preparation and initials of technician/analyst;
(d) date of standardization and initials of technician/analyst; and
(e) standardization factor.