8.4 Quality Systems in the Analytical Laboratory
(2) A detailed description of the laboratory.
(3) The organization and management systems.
(4) The staff, with specification of hierarchies, positions, experience, etc.
(5) A description of the available means (materials, instruments, apparatus).
(6) The analytical methods used, described in detail.
(7) The laboratory's ambient conditions and their maintenance.
(8) Documenting and archiving activities.
(9) Sample reception, monitoring and control systems.
323
(10) The systems used to verify the results, which involves checking both the analytical
methods (e.g. with blind samples) and other aspects (e.g. sample-result correspondence).
(1 1) The systems used to diagnose generic errors and derive specific corrective actions.
(12) Other aspects such as participation in interlaboratory studies, audits, etc.
8.4.3 Good Laboratory Practices
Good Laboratory Practices (GLPs) constitute an alternative to the standards
derived from ISO Guide 25. They have been established worldwide by institutions such as the Organization for Economic Cooperation and Development
(OECD) and the European Union; also, national governments have adapted and
published them in their official gazettes as imperative rules for laboratories
engaged in the analysis and assessment of substances with potential social
implications, which, as such, require regulation. Typical examples include
pharmaceutical formulations, foods, cosmetics and environmentally aggressive
products. GLPs can be defined as "a body of rules, operating procedures and
practices established by a given organization (e.g. OECD, EU) that are considered to be mandatory with a view to ensuring quality and correctness in the
results produced by a laboratory:'
A detailed description of GLPs falls outside the scope of this book. Although
they have a different structure, they share many practical connotations with
ISO Guide 25. In addition, they contain two unique elements called Standard
Operating Procedures (SOPs) and the Quality Assurance Unit (QAU).
Standard Operating Procedures are detailed descriptions of all the activities
performed by a laboratory. SOPs must exist, for example, for sample handling;
reagent usage; reference materials; method, instrument and apparatus supervision; archiving activities; etc. SOPs must be followed literally, with no
alteration. If a change is pertinent, then it must be documented in written form
and the actions involved be the subject of an SOP as well. Standard Operating
Procedures are the equivalents of "procedures" in the Quality Manual.
One other essential element of GLPs is the so-called "Quality Assurance Unit"
(QAU), which should be independent from the laboratory and answerable to the
manager or president of the body with which the laboratory is affiliated. The
QAU is directly responsible for instituting quality, controlling and assessing it,
and proposing actions to enhance it. The unit provides an audit that its external
to the laboratory but internal to its parent body (see Fig. 8.11).
(2) A detailed description of the laboratory.
(3) The organization and management systems.
(4) The staff, with specification of hierarchies, positions, experience, etc.
(5) A description of the available means (materials, instruments, apparatus).
(6) The analytical methods used, described in detail.
(7) The laboratory's ambient conditions and their maintenance.
(8) Documenting and archiving activities.
(9) Sample reception, monitoring and control systems.
323
(10) The systems used to verify the results, which involves checking both the analytical
methods (e.g. with blind samples) and other aspects (e.g. sample-result correspondence).
(1 1) The systems used to diagnose generic errors and derive specific corrective actions.
(12) Other aspects such as participation in interlaboratory studies, audits, etc.
8.4.3 Good Laboratory Practices
Good Laboratory Practices (GLPs) constitute an alternative to the standards
derived from ISO Guide 25. They have been established worldwide by institutions such as the Organization for Economic Cooperation and Development
(OECD) and the European Union; also, national governments have adapted and
published them in their official gazettes as imperative rules for laboratories
engaged in the analysis and assessment of substances with potential social
implications, which, as such, require regulation. Typical examples include
pharmaceutical formulations, foods, cosmetics and environmentally aggressive
products. GLPs can be defined as "a body of rules, operating procedures and
practices established by a given organization (e.g. OECD, EU) that are considered to be mandatory with a view to ensuring quality and correctness in the
results produced by a laboratory:'
A detailed description of GLPs falls outside the scope of this book. Although
they have a different structure, they share many practical connotations with
ISO Guide 25. In addition, they contain two unique elements called Standard
Operating Procedures (SOPs) and the Quality Assurance Unit (QAU).
Standard Operating Procedures are detailed descriptions of all the activities
performed by a laboratory. SOPs must exist, for example, for sample handling;
reagent usage; reference materials; method, instrument and apparatus supervision; archiving activities; etc. SOPs must be followed literally, with no
alteration. If a change is pertinent, then it must be documented in written form
and the actions involved be the subject of an SOP as well. Standard Operating
Procedures are the equivalents of "procedures" in the Quality Manual.
One other essential element of GLPs is the so-called "Quality Assurance Unit"
(QAU), which should be independent from the laboratory and answerable to the
manager or president of the body with which the laboratory is affiliated. The
QAU is directly responsible for instituting quality, controlling and assessing it,
and proposing actions to enhance it. The unit provides an audit that its external
to the laboratory but internal to its parent body (see Fig. 8.11).