ORA-LAB.5.5 Equipment v02
ORA-LAB.5.5 Equipment v02
ORA-LAB.5.5 Equipment v02
Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revision Date:
ORA-LAB.5.5
ORA Laboratory Manual Volume II 06/06/2019
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Equipment
1. Purpose................................................................................................................................... 1
2. Scope...................................................................................................................................... 1
3. Responsibility.......................................................................................................................... 2
4. Background............................................................................................................................. 2
5. References.............................................................................................................................. 2
6. Procedure................................................................................................................................ 3
6.1. Equipment Identification and Records...........................................................................3
6.2. Equipment Qualification................................................................................................4
6.3. Equipment Maintenance and Intermediate Performance Checks..................................4
6.4. Equipment Calibration or Verification............................................................................5
6.5. Out of Service Equipment.............................................................................................5
6.6. Equipment Leaving Direct Control of the Laboratory.....................................................6
6.7. Handling, Use, Storage and Transport of Equipment....................................................7
7. Glossary/Definitions................................................................................................................. 8
8. Records................................................................................................................................... 9
9. Supporting Documents............................................................................................................ 9
10. Document History.................................................................................................................. 10
11. Change History...................................................................................................................... 10
12. Attachments........................................................................................................................... 10
Attachment A - Equipment Requirements..............................................................................11
1. Purpose
2. Scope
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Equipment
These
procedu
res
apply to
the
analytic
al
testing
equipm
ent
used by
the
Office of
Regulat
ory
Science
(ORS)
laborato
ries.
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Equipment
3. Responsibility
A. Laboratory Management
1. Ensures the laboratory is equipped with equipment that meets
the specifications of the analytical methods used.
2. Ensures equipment maintenance and calibrations are conducted.
3. Provides support for arranging non-routine instrument repair
and ordering replacement instrument parts.
4. Designates equipment monitors.
B. Assigned Monitors
1. Maintains equipment logbooks
2. Performs periodic equipment checks
3. Ensures equipment is maintained in accordance with their
respective requirements.
C. The Quality Management System Manager
1. Ensures monitoring of equipment records.
2. Ensures laboratory equipment is calibrated and maintained
in accordance with accreditation requirements.
D. Staff
1. Verifies equipment conforms to specifications prior to use.
2. Completes the record of this verification.
3. Adheres to written equipment operation procedures.
4. Background
None
5. References
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Equipment
Supplem
ents,
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Equipment
6. Procedure
6.1. Equipment Identification and Records
A. All equipment in the FDA equipment inventory system is labeled with
a unique identification number (e.g. FDA bar code number). Generally,
equipment not bar coded under the FDA-wide inventory system is
identified under the laboratory's own unique numbering system.
B. Each laboratory maintains an inventory of its major equipment used
to perform regulatory testing. This inventory contains the following
information:
1. Item and its software version,
2. Manufacturer and model,
3. Serial number or other unique identification, and
4. Location
C. The label or tag found on or near the equipment contains the
following information:
1. FDA bar code or unique identification number,
2. Date of last calibration, and
3. Date of the next calibration.
D. Equipment that is scheduled to be calibrated daily or with each use,
is tagged as above, except that instead of the calibration dates, it is
annotated as such (e.g. calibrated daily or calibrated with each use).
E. Small items with insufficient space to record the information on the
label (e.g. thermometers) need only be identified with their unique
identification number for traceability to their associated records.
F. Detailed guidance on equipment records is provided in ORA-
LAB.5.5.1. Equipment Records.
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Equipment
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the discretion of local laboratory management.
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Equipment
if
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Equipment
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Equipment
7. Glossary/Definitions
A. Calibration – Calibration is the set of operations, under specified
conditions, establishing the relationship between values of quantities by
a measuring instrument or measuring system, or values represented by
a material measure or reference material, and the corresponding
values realized by standards.
B. Certified reference material (CRM) – A CRM is a reference material,
whose property values are certified by a technically valid procedure,
accompanied by or traceable to a certificate or documentation issued
by a certifying body.
C. General service equipment – General service equipment is laboratory
equipment that is not used for measuring but that can affect the
results of an analysis. Examples include grinders, blenders, ovens,
furnaces, hotplates, stirrers, non-volumetric glassware used for
approximate volume measurements (e.g. measuring cylinders),
laboratory heating, and ventilation systems.
D. Installation qualification (IQ) – This is the identification of all system
elements, electrical or otherwise. This identification and the
subsequent documentation for each installed item details normal
operating instructions, routine user maintenance, preventive
maintenance and cleaning procedures.
E. Measuring instruments – This includes balances, chromatographs,
spectrometers, thermometers, timers, viscometers,
electrochemical meters.
F. Operational qualification (OQ) - OQ is generally described as
commissioning. It includes calibration and critical instrument test
parameters defined for the use and purpose of the instrument, and
may include the definition of upper and lower tolerances.
G. Performance qualification (PQ) - PQ relates to the daily use of the
instrument and is designed to measure routine performance. Details
of work instructions and specifications are included.
H. Physical standards – Physical standards includes reference
weights and reference thermometers.
I. Reference Standard – A reference standard usually has the highest
metrological quality found at a given location in a given organization,
from which measurements made there are derived. Generally, this
refers to recognized national or international traceable standards
such
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Equipment
8. Records
9. Supporting Documents
None
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Equipment
12. Attachments
List of Attachments
Attachment A - Equipment Requirements..................................................................11
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Equipment
Calibrate3 Annually
dietary supplements
Dispensing equipment & Mass measurement/volume Verify at installation & daily when in use
vial fillers used in at each volume dispensed
Microbiology
Freeze dryers, vacuum Ability to achieve & sustain Verify at installation and annually
ovens vacuum; vacuum gauges verified thereafter
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Equipment
pH meters ion selective, Calibrate against reference buffer5 Each day of use
& related conductivity or reference solution at level of use
equipment5 or bracketing range of use
Temperature controlled Verify temperature Check daily am and pm when in use with
chambers used for at least 4 hours between verifications
testing (e.g. ovens,
furnaces, incubators, Uniformity of temperature1 by At installation (or initial use) and after
water baths) mapping the chamber nonroutine maintenance7
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Equipment
Volumetric delivery Accuracy & precision using mass of Verify upon receipt (manufacturer’s
devices: mechanical water at a known temperature or by Certificate of Accuracy may be accepted)
pipets, micropipettes, spectrophotometric method
mechanical burets, & Minimum every 6 months
liquid dispensers
Water activity meter Water activity of known solutions Verify daily when in use5
Water, used in all Method specific water quality Minimally every month
analyses to meet method attributes
requirements
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Equipment
1. Nonpotable https://www.fda.gov/ICECI/Inspections/In
2. Potable (drinkable) water spectionGuides/InspectionTechnicalGuide
3. USP purified water s/ucm072925.htm
4. USP water for injection
5. USP sterile water for injection
6. LUSP sterile water
for inhalation
7. USP bacteriostatic water for
injection
8. USP sterile water for irrigation
Weights, reference Mass Calibrate every 5 years3
NOTES:
1. Uniformity may not be needed for low-capacity equipment such as small chambered autoclaves,
incubators, ovens, & refrigerators; circulating water baths; muffle furnaces; & freezers based on use
or design. In these cases, the laboratory should have reasonable justification and document the
justification for not determining uniformity and suitability.
2. Autoclaves equipped with a calibrated temperature sensing device that provides a record
of temperature are considered to meet this requirement.
3. All weights & balances shall be calibrated traceable to recognized national or international units
(NIST, BIPM, OIML, or equivalent traceable weights). They must be calibrated by an ISO/IEC
17025accredited calibration laboratory.
4. For quantitative methods, an analytical standard at the mid-range or lower of the calibration curve
can verify detector response. For qualitative assessments, the appropriate response material must be
used.
5. When pH or water activity results are reported to the customer or may be a significant component
of overall uncertainty of the measurand, the reference material (e.g. buffer or water activity
analytical standard) must satisfy the requirements for metrological traceability. Buffers used for
this purpose must be obtained from an ISO 17034-accredited manufacturer.
6. The intent is the laboratory must be able to verify that samples were stored at the proper temperature
for the duration of storage. Continuous monitoring with a calibrated and validated system meets this
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Equipment
7. When determining mapping schedules, attention should be paid to extremes in laboratory ambient
conditions (such as those brought on by seasonal changes) that can influence the performance of the
equipment. Initial and nonroutine maintenance monitoring can be done with no load.
8. Timers and internal timing devices only need to be verified when time is a critical factor in the
test method. Time may not be a critical factor when time is not the reported result or a precise
time is not required for the test method.
9. Accrediting bodies may require Initial calibration by an ISO 17025 accredited calibration laboratory.