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Draft 6. Note: This document is a draft suggestion only and is not an approved document.
Please do not distribute to laboratory staff for use.
5.3.3
Frequently, it will be necessary to segregate certain types of work that are prone to interference from other
work, or which present particular problems or hazards. Examples include but are not limited to areas for reagent
preparation or trace analysis instrumentation where physical separation to avoid systems contamination is necessary.
When selecting designated areas for special work, account shall be taken of the previous use of the area. Before use,
confirm the area is ready for use. Once in use, access to such areas shall be restricted, as needed, and the type of work
undertaken there carefully controlled.
5.3.4
“It may be necessary to restrict access to particular areas of a laboratory because of the nature of the work
carried out there. Restrictions might be made because of security, safety, or sensitivity to contamination or
interferences. Typical examples might be work involving explosives, radioactive materials, sterility testing,
carcinogens, forensic examination, polymerase chain reaction (PCR) techniques, and trace analysis. Where such
restrictions are in force, staff shall be appropriately trained on the:
•
intended use of a particular area
•
restrictions imposed on working within such areas
•
reasons for imposing such restrictions
•
procedures to follow when such restrictions are breached"
[
CITAC/Eurachem Guide to Quality in Analytical Chemistry: An Aid to Accreditation
(2002)]
5.3.5
For pharmaceutical laboratories, cleaning and sanitization schedules shall be established by the laboratory for
laboratory areas (benches, floors, etc.) and for laboratory equipment (incubators, water baths, centrifuges,
refrigerators, freezers, etc.). Sanitization of key areas and equipment shall be recorded.
For microbiological testing, in cases where sterile supplies are necessary, the supplies shall be purchased as sterile or
sterilized in the laboratory (e.g., gloves, pipettes, pipette tips, petri dishes, tongs, etc.). If the laboratory sterilizes the
item, it shall maintain the item in a sterile condition/environment.
5.4 Test and Calibration Methods and Method Validation
5.4.2
Selection of Methods
Matrix and analyte matched Certified Reference Materials, when available, shall be used to determine any systematic
method bias. Where this is not possible, method bias shall be determined by using a variety of techniques, preferably
based on different principles of analysis. All laboratory-developed and non-standard methods shall be fully
documented, including validation data, limitations of applicability, procedures for quality control, and calibration.
Determination of measurement uncertainty shall form part of the method validation process.
The laboratory must confirm it can properly perform standard methods
before
these are used in routine testing (e.g. it
is not appropriate for the laboratory to run concurrent controls and/or reference materials in order to qualify their
competence to perform the method at same time they are running the sample, rather the laboratory must be able to
properly prove the method is fit for purpose beforehand).
Note
: Where no method is specified, the laboratory shall choose an appropriate method. Examples of food, dietary
supplement, and pharmaceutical methods are found in AOAC, USDA, FDA, EPA, AOCS, AACC, ISO, IUPAC, USP,
and FCC method manuals. Many trade associations publish their own methods and provide useful resources. A few
examples include the Corn Refiners Association, National Food Processors Association, Association for Dressings
and Sauces, and the American Spice Trade Association.
The laboratory shall record the laboratory representative who authorized adoption of the method and the date this
authorization was granted.
Adjustments to maintain system suitability specifications that do not alter the fundamental nature of the method may
be made without validation. Modifications of methods that alter the fundamental nature of the method shall be
validated to demonstrate that equivalent results are obtained and that the method is suitable for its intended use.
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