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1.0 PURPOSE
1.1 The purpose of the Master Calibration Plan is to define the requirements
necessary for establishing and implementing an effective Calibration
Control Program. The aim of the Calibration Program is to ensure that all
Measuring and Test Equipment (M&TE) included in the program are
calibrated to within the manufacturers accuracy specifications or to the
tolerances required by the application. Documented trace ability to either the
National Institute of Standards and Technology (NIST) or other applicable
agency must be maintained.
2.0 RESPONSIBILITIES
2.1 Quality Assurance Personnel:
2.1.1

QA Personnel will establish a mechanism for assuring the

adequacy of the calibration program that includes:
-Re-evaluation of all product acceptance decisions utilizing
equipment or instrumentation which was subsequently determined
to be out-of-tolerance.
-Review and approval of decisions to include or exclude M&TE
into the calibration and/or service program.
-Review and approval of calibration and/or service intervals.
-Review the adequacy of measurement accuracy for
product/process/process acceptance and adjustments of product
acceptance limits, or other actions required to assure adequate
measurements.
-Audit the calibration system and M&TE usage to assure
compliance with the intent of this document.

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-Review to ensure that product specification changes, new

accuracy requirements, and current GMP requirements have been
included in the calibration program.
-Review calibration agency performance to assure appropriate
technical levels are maintained.
2.1.2

Responsible for auditing appropriate functions for compliance to

this protocol.

2.1.3

Responsible for assuring that program action items identified in

this document are implemented.

2.1.4

Responsible for assuring that all metrology personnel have the

proper training and that documentation of the training is kept on
file.

2.1.5

Responsible for final approval of all documents relating to

metrology department.

2.1.6

Responsible in tracking document revisions and assuring that all

documents in use are current.

2.2 Metrology Personnel:

2.2.1

Responsible in implementing the Calibration Program.

2.2.2

Responsible for developing and maintaining a controlled

2.2.3

Metrology Standards Laboratory to support the ongoing cGMP

processes at the Facilities.

2.2.4

Metrology and Facilities personnel will be utilized to support all

departments, using M&TE, within the company, wherever
possible. Outside calibration agencies may be used at the
discretion of Metrology, provided that the calibration agency has
been pre-audited by Metrology and/or QA and found to be in
conformance with this document.

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2.2.5

The calibration program must be strictly adhered to and downtime of equipment must be kept to a minimum.

2.2.6

Accountable for notifying Production and QA personnel of any

discrepancies found in instrumentation during routine maintenance
and calibration. All discrepancies must be recorded on a GMP
Incident Report which must then be forwarded immediately to the
QA Manager.

2.2.7

Metrology and QA shall evaluate the procedures outlined in this

protocol annually. This evaluation will include monitoring and
updating to ensure compliance with cGMPs.

2.2.8

Production equipment and calibration programs shall be strictly

adhered to and Down Time of equipment will be kept to a
minimum.

2.3 Instrument Users:

2.3.1

2.3.2

2.3.3
2.3.4

Responsible for ensuring that all instruments which are used in a

cGMP process are included in Metrologys computerized
calibration scheduling system. Any instruments which do not have
a calibration label affixed are not part of the system. The user must
complete an Instrument Form in full and forward to the corporate
metrology for entry into the system. The instrument will then be
studied, calibrated, and a calibration label will be affixed. The
instrument will then be automatically tracked, and the user will be
notified when re calibration is due.
Calibrations required on a daily basis or prior to use of the
equipment such as balances, and pH meters will be the
responsibility of the individual user even though less frequent and
more intense calibrations maybe performed by metrology.
To maintain accurate records of calibration for each piece of
equipment used in cGMP related activities. These records are to
include calibration, repair and maintenance data.
Users wishing to acquire instruments must consult with the
corporate metrologist before purchasing to ensure that the
instrument is adequate for their application.

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3.0 TERMINOLOGY AND DEFINITIONS

3.1 Accuracy The closeness of agreement between an observed or measured
value and an accepted reference value.
3.2 Calibration The comparison of a measurement system or device of
unknown accuracy to another measurement system or device with a known
accuracy to detect, correlate, report or eliminate by adjustment any variation
from the required performance limits of the unverified measurement system
or device.
3.3 Calibration Control Program A system that provides control of all
devices which have been accepted into the calibration and/or service
program as measurement standards or M&TE and which includes the
approval, maintenance, inspection, handling, transportation, use, calibration,
service and repair and cleaning of these devices.
3.4 Calibration Interval The elapsed time between a calibration and the
subsequent calibration.
3.5 Calibration S.O.P. A Standard Operating Procedure which provides the
written procedure for performing the calibration and/or service of M&TE to
obtain predefined accuracy and performance requirements.
3.6 Calibration Status Identification of all M&TE as to the type of calibration
or maintenance required and if calibrated, the current calibration validity.
This validity is dictated by whether the calibration period has or has not
elapsed.
3.7 Family An instrument of equipment family denotes a population or group
of like equipment built to perform the same type of measurements or
functions exclusive of manufacturer and model. Grouping equipment into a
family does not imply that they will have the same range or accuracy
capabilities.
3.8 Good Manufacturing Practice (cGMP) United States (FDA) Food and
Drug Administration Regulations.

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3.9 Instruments M&TE used for confirming measurements related to the

product or Validation or used for generating reportable data.
3.10 Measurement Standard A device, solution, material, or radioisotope
sealed source used as a reference for measurement, and which is traceable to
NIST or NRC or other recognized source, or derived from accepted values of
natural physical constants. Measurement standards designations include
reference, certified, and transfer standards.
3.11 Measurement Trace ability Measurement trace ability is the ability to
relate individual measurement results to NIST standards through an
unbroken chain of comparisons.
3.12 Measuring and Test Equipment Devices and instruments used to test,
measure, calibrate, evaluate, inspect or otherwise examine materials,
supplies, equipment, and systems to determine compliance with
specifications established in technical documents.
3.13 Metrology Develops and evaluates calibration systems that measure
characteristics of objects. Substances, or phenomena, such as length, mass,
time, temperature, electric current, luminous intensity, and derived units of
physical or chemical measure: Identifies magnitude of error sources
contribution to uncertainty of results to determine reliability of measurement
process in quantitative terms. Redesigns or adjusts measurement capability
to minimize errors. Develops calibration methods and techniques based on
principles of measurement science, technical analysis of measurement
problems, and accuracy and precision requirements. Directs engineering,
quality, and laboratory people in design, manufacture and evaluation, and
calibration of measurement standards, instruments and test systems to insure
selection of approved instrumentation.
3.14 Metrology The reference standards laboratory which possesses and uses
M&TE of the required order of accuracy, including reference, certified, and
transfer standards to provide measurement support to all applicable in house
precision equipment.
3.15 Precision The quality or state of being precise. Used or intended for
precise measurements. Made for the least variation from a set standard.

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3.16 Scheduling System A scheduling system is established to assure that

M&TE is calibrated at planned intervals and that instruments which cannot
be properly labeled will not miss these intervals.
3.17

Service Inspection of test equipment, or other calibration equipment or

systems, which is intended to detect malfunctions and assure reliable
operating during the calibration/service interval and to prevent deterioration
due to age or usage. Examples or service are:
o Visual check for damage, wear and surface quality.
Operational tests for secondary functional characteristics
such as distortion, ripple, regulation and sensitivity.
o Also includes preventative maintenance such as cleaning,
lubricating, filter replacement and painting.
o All services rendered will be documented.

4.0 GUIDELINES
4.1

Calibration Intervals:
4.1.1

4.1.2
4.1.3

M&TE should be calibrated at intervals established with the intent

of achieving and maintaining a desired level of accuracy and
quality. All M&TE will be calibrated at the manufacturers
recommended calibration interval, to assure that M&TE is
operating within its accuracy specifications. Calibration data will
be recorded and then analyzed, to determine the optimum
calibration interval. The calibration interval will then be adjusted
to reflect this analysis. All instruments will be calibrated at least
annually to assure compliance with cGMPs. The trending and
analysis of calibration data will be a continuous process and if the
data shows that an instruments accuracy has degraded much faster
than expected, the calibration interval must be adjusted to reflect
this change.
Interval Applications
Intervals may be applied to single items or groups of items that are
reasonably similar with respect to family and responsibility.
Interval Types
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Calibration Intervals must be determined for each piece of

equipment and may be fixed or variable.
4.1.4

Interval Units
Calibration Intervals must be determined for each piece of
equipment and may be based upon calendar, cumulative, utilization
time or any other suitable criteria.

4.1.5

Interval Assignment
Calibration intervals shall be assigned to attain a desired
probability that M&TE will be within documented accuracy
specifications at the time of re-calibration. Initial intervals for new
equipment shall be based on the equipment manufacturers
recommendation, engineering judgment, or other appropriate
source. Calibration intervals will be set forth in the individual
calibration S.O.P.s and will then be recorded and tracked in the
computerized calibration database.

4.1.6

Calibration Intervals may be adjusted, as necessary, on the basis of

calibration data or other information which may support a change.
Any calibration interval adjustment shall be discussed with the
user and Validation Services, documented by Metrology and shall
be approved by QA.

4.1.7

Standard Grace
M&TE requiring scheduled calibration will have a standard grace
period. Annual calibrations will be performed every 365 days 10
days. Semi annual calibrations will be performed every 182 days
5 days. Quarterly calibrations will be performed every 91 days 5
days.

4.1.8

Temporary Interval Extensions

Calibration Intervals may be temporarily extended beyond the
standard grace period due to critical tests, production schedules or
other requirements provided that:
4.1.7.1.
Extension Limitations

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The length of extension shall be limited by

documented policy. Only one extension per
calibration interval is permitted.
4.1.7.2.

Product Acceptance

4.1.7.3

The batch or product shall be quarantined pending

the results of the calibration.
Extension Approval
A temporary authority request must be completed
and forwarded to QA before an interval extension
can be approved and put into effect.

4.2

Measurement Traceability:
The calibration system will provide the means to directly or
indirectly trace assigned values of measurement equipment to
values in terms of the NIST or equivalent body.
4.2.1

Traceability Documentation
Documentation which substantiates and identifies the
means of achieving direct traceability should include
information such as:
Calibration Agency Identification of the agency
which performed the calibration.
Certification Data The certified values determined by
the measurement process, where applicable and
required.
Date of Calibration and Reference Traceability Report
of Certificate.

4.3

Adequacy of Calibration Equipment:

Items should be calibrated using measurement systems having
adequate accuracy, stability, and range to completely verify the
performance of the calibrated item within its specified uncertainty
limits. All calibration shall be performed with test standards that have
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a minimum accuracy 4 times that of the device under test, wherever

possible, and will be traceable to NIST or equivalent body. All test
standards will be set up and will remain within the controlled
environment of the Metrology Laboratory to ensure stability of the
instruments and repeatability of tests. Instruments may be removed
from the calibration lab by meterologists to be shipped for repair or
calibration and for the purpose of performing field calibrations.
4.4

Contractor Control:
When Metrology elects to use an outside contract maintenance and
calibration service organization to service its M&TE, it is the
responsibility of Metrology and QA to ensure that the contractors
Calibration Control system complies with all the companys
requirements. Metrology personnel will provide pre-approval of a
vendor, however, QA must perform an audit to ensure compliance with
cGMPs. To realize this assurance it is desirable that an agreement be
established that assures that the outside contract service organization:
Will use approved procedures outlining methodology used in
maintaining and calibrating the clients M&TE.
Will provide a complete system calibration and is willing to
give a certified report of calibration, complete with all
necessary supporting documentation.
Will allow periodic audits of facilities and records by their
client and/or the clients authorized representative.

4.5

Records:
Records will be maintained for all M&TE that are included in the
Calibration Control Program. The Individual calibration history files
will be prepared and maintained for each instrument. These records
will be maintained and will be stored in the metrology laboratory.
4.5.1

Content
The records will include:
Identification
Location
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Calibration History
Calibration Control
Traceability Documentation
4.5.1.1 Identification
On receipt of an Instrument Form, a unique nonrepetitive identification will be assigned to each
item of M&TE in the calibration system.
4.5.1.2 Location
Records will provide information necessary to
locate equipment due for calibration.
4.5.1.3 Calibration Control and History
A record system will be maintained on M&TE
requiring calibration to provide the information
necessary for control, audit, and history of the
calibration system. The system will include:
The date of each calibration and the date
due for recalibration.
Signatures of the individual who
performed the calibration and of the
individual who reviewed and approved
the calibration record.
Records of out-of-tolerance conditions.
Information or location of information
necessary to duplicate all graphs, tables,
reports, certificates issued with the
instrument.
The report or location of reports received
from outside laboratories indicating
instrument accuracy.
Identification of the standards used in
performing the calibration.

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Identification of the procedure employed

in performing the calibration.
4.5.1.4 Traceability Documentation
The record will provide all documentation that
substantiates and identifies the means of
achieving direct or indirect traceability in terms
of nationally or internationally recognized
standards.
4.5.1.5. Logbook
Logbooks will be kept for all M&TE and will
contain data covering calibration, repair,
maintenance, and cleaning of equipment.
These logbooks will be stored in the Metrology
laboratory.
4.5.1.6. Retention
The Metrology Laboratory will retain
calibration records for a period of not less than
five years to allow sufficient time for analysis
of data and decisions to be made pertaining to
calibration interval adjustments. Calibration
records may then be transferred at the
discretion of the corporate meterologist to
archive filling cabinets stored in the metrology
laboratory or other controlled archival areas
located on company premises. To ensure
compliance with regulatory requirements,
these records must then be retained for an
additional fifteen years or until the expiration
date of products being produced has been
reached, whichever is greater.
4.6

Scheduling System:

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In order to optimize the management of the equipment inventory, a

computerized system will be utilized to maintain a system for
scheduling the periodic calibration of equipment. This computerized
system will provide for the following:
Scheduling of calibrations of M&TE on the due date or within the
Grace period specified in section 4.1.6 of this document. In some
cases, it may be appropriate to calibrate M&TE before use, not on a
periodic schedule.

4.7

Allow for user notification of pending calibrations in order to

resolve scheduling conflicts.
Provide a mechanism for interval extensions in the event that
scheduling conflicts cannot be resolved due to production
schedules or critical tests.
Identifying or removing from service equipment which has
exceeded the calibration due date.
When new equipment is received, it must be entered into the
calibration program before being put into service.

Labeling Practice:
In order to alert the user to the status of a piece of equipment, all
calibrated equipment will be labeled or coded to indicate its status.
Labels have been designed and made of materials suitable to the
working environment. Examples of labels would be
CALIBRATED, CALIBRATION NOT REQUIRED, and
LIMITED CALIBRATION labels identifying the equipment status.
4.1.1

Function
Labeling of equipment will be performed to serve the
following functions:
-

Alerts the user to its calibration and operation

status.
Shows that the instrument is part of the inventory
and scheduling system.
Shows that each piece of equipment has been
studied regarding its need for calibration or
maintenance.

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Applies tamperproof seal (where appropriate) to

prevent operator adjustment.

4.7.2. Location
Where practical, all labels will be placed in a prominent place on
the instrument. This alerts the user to its calibration status.
4.7.3

Content
The calibration labels will include:
-

4.7.4

Date of last calibration

Date due (or usage time) for re-calibration.
The person responsible for the calibration
Calibration certificate number.

Labeling Impracticality
When the size or function of an instrument precludes the
application of a label, a coded marking should be applied to
indicate calibration status. Where this is not possible, a copy of the
Calibration Certificate will be forwarded to the user. It is the
users responsibility to be aware of its calibration status. The user
will be notified by metrology one month prior to the calibration
due date of the instrument.

4.7.5

System Calibration
System calibrations involving many individual calibrated
components require calibration labels affixed to each calibrated
component and a single label affixed to the system as a whole in a
prominent location.

4.7.6

Representative Types
The representative types, which will be used, are as follows:

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4.8

Date

Standard Calibration Label supplied by the

applicable Standards Laboratory and applied to
metrology references and standards only.
Calibration Label Placed on instruments
calibrated, as required, on a periodic basis.
Available in Critical and Non Critical formats.
Calibration Not Required Place on
instruments which by their nature of use do not
require calibration.
Calibration Void if Seal Broken indicates that
calibration is invalid if the seal is removed.
Do Not Use Until Tested and Calibrated
Indicates that the instrument has not been certified
for use and must not be used for GMP activities
until certified by Metrology.
Rejected Indicates that the instrument failed
calibration and must be repaired or replaced.

Calibration Procedures:
Standard Operating Procedures (S.O.P.s) will be prepared containing
sufficient information for the calibration of measurement equipment.
4.8.1

Requirements
4.8.1.1. Source The calibration SOPs will be prepared
internally.
4.8.1.2 Completeness- The SOPs should contain sufficient
instruction and information to enable qualified
personnel to perform the calibration.
4.8.1.3 Approval All internally prepared procedures must
be approved before use by the individuals responsible
for SOP approval.

4.8.2

Format
The internal procedures should include information such as:

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SOP Title Manufacturer, type or model number of

equipment to which the SOP applies.
Purpose This will define the purpose of the SOP
Required Documentation and Materials A list of all
applicable reference materials, manuals, check sheets,
calibration standards, associated equipment and
accessories required to perform the calibration.
Safety - (As required) describes any safety
considerations that must be observed.
Procedure - Description of the calibration process with
any required references, calibration check sheets,
environmental considerations, data sheets, and other
information helpful or necessary to perform the
calibration.
Acceptance Criteria This will include the acceptable
accuracy limits for the instrument under test which will
be used to define whether an instrument has passed or
failed.
5.0 CALIBRATION QUALITY
The Calibration Control System will be designed to achieve and maintain a high level
of quality consistent with the calibration program requirements.
5.1 Calibration Quality Levels:
Quality levels may be determined in terms of equipment groupings with
similar characteristics or for individual systems. The quality level of M&TE
may be expressed as average in-tolerance rate, acceptable quality level, failure
rate, or any other means which provides a meaningful measure. M&TE
quality levels will normally be expressed in terms of average in-tolerance rate.
5.2 Deviation From Quality Level:

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If a quality level is consistently above or below the specified quality level,

actions may be taken to reduce the difference between the specified intended
goal and the actual quality level. Typical of such actions are:
Interval Adjustment
Procedure Change
Revision
Removal of Equipment from Service
Instrument Repair and/or Refurbish
Instrument Upgrade
6.0 ENVIRONMENTAL CONTROLS OF THE METROLOGY LABORATORY
The calibration environment will be controlled to surpass the parameters required by
the most environmentally sensitive measurement performed in the area. To ensure
continued calibration accuracy, acceptable ambient operating conditions have been
established. Control of essential environmental factors such as temperature, relative
humidity, air pressure differentials, vibration, electromagnetic interference, and
voltage regulation of electrical power will have been considered during the
construction phase.
6.1 Metrology Ambient Operating Condition Limits:
Metrology Ambient Temperature, Relative Humidity, and general cleanliness
will be monitored on a continual day-to-day basis. Chart recorder or
electronic records of the temperature and humidity will be kept on file for a
period of 10 years.
6.1.1

6.2

Temperature will be monitored on a continual basis utilizing an

NIST or equivalent traceable circular chart recorder.
-

The Metrology Laboratory ambient temperature

must be 22C 2C.

Relative Humidity must be 20% - 40% with no

more than a 5% change in the reading over a onehour period.

Cleanliness:
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Cleanliness should be maintained to the proper degree in the

calibration areas.
This cleanliness condition is to be consistent with Good
Housekeeping Practices.
6.3

Loss of Environmental Controls:

In the event that environmental control is lost and the ambient
operating conditions exceed the established limits, all calibrations
within the effected areas shall stop until either; Control is returned
and an appropriate stabilization has been achieved.
An evaluation of the effects indicate that the loss of control has no
detrimental effect to the area calibration.
NOTE: The length of the stabilization time will be determined by
environmental variables. All controlled variables must return to
within normal operating parameters and remain constant during
three consecutive measurements taken within a 30-minute period
to be considered stable.

6.4 Field Calibrations:

Calibrations will be performed under normal laboratory conditions.
Temperature and humidity shall be monitored and recorded in the Metrology
logbook during the calibration process.
7.0 PERSONNEL REQUIREMENTS
7.1 Selection and Training:
The selection and training of competent personnel is an important
consideration in establishing and maintaining an effective Calibration Control
Program. Calibrations should be performed by personnel having the
necessary education, training, background, and experience.

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Technical / Academic Requirements

The following Technical/Academic requirements should be sought
in a Metrologist:
- Academic High School Diploma or equivalent;
- Instrumentation Diploma from a recognized
Technical Institution or equivalent;
- Journeyman Instrument Mechanic Trade
Certificate or equivalent experience directly
related to the trade preferred but not required;
- Certified Engineering Technologist (C.E.T.)
designation preferred but not required.

7.1.2

Education/Training
Personnel performing calibrations of measurement instrumentation
and devices should have technical education and training in the
area of job assignment. This includes calibration aspects of GLP
and GMPs, documentation, calibration procedures, calibration
adjustments, and use of measurement equipment and standards.

7.2

Qualifications Documentation:
7.2.1

All Certificates, Diplomas or other documentation relating to the

qualifications of a metrologist shall be kept in a file to be produced
upon request for inspection. This file shall be held separate from
the personnel file, which is to remain personal and confidential.

8.0 COMPUTER SOFTWARE

8.1 Calibration Control Program Maintenance
Computer Software will be used to assist in the maintenance of the Calibration
Control Program.
8.2 Calibration Data Trending and Analysis:

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Commercial software will be used to trend and analyze instrumentation

calibration data. This analysis will determine the optimum calibration
interval, which is not to exceed one year.
8.3 Automation of Calibration Testing:
Software may be developed or purchased from a vendor to be used in
conjunction with M&TE to automate calibration routines and the acquisition
of calibration data.

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9.0 REFERENCES
9.1

MIL-STD-45662, Military Standard Calibration System Requirements,

Dated August 1, 1988.

9.2

NCSL recommended Practices:

RP-1 Establishment and Adjustment of Calibration Intervals, dated
November 15, 1989.
RP-2 Evaluation of Measurement Control Systems and Calibration
Laboratories, dated July 3, 1979
RP-3 Preparation of Calibration Procedures, dated January 11, 1990
RP-4 Calibration Systems Specification, dated July, 1971
RP-5 Preparation of Specifications, dated May 5, 1980
RP-6 Medical Products and Pharmaceutical Industry Calibration
Control System, dated July 10, 1986.

9.3

U.S. Food and Drug Administration, Department of Health and Human

Services, Good Manufacturing Practice for Finished Pharmaceuticals.

9.4

U.S. Food and Drug Administration, Department of Health and Human

Services, Current Good Manufacturing Practice for Medical Devices.
General: 21 CFR820.

9.5

U.S. Food and Drug Administration, Department of Health and Human

Services, Good Laboratory Practice for non-clinical studies. 21CFR58

9.6

Guidelines on Calibration and Measurement Accuracy, ASTM

Committee E-46 (Quality Provisions in ASTM Standards).

9.7

American National Standards for Calibration Systems, ANSI-1

Committee, Writing Group of Quality Standards for Calibration

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Calibration Laboratory Managers Guidebook, The National Conference

of Standards Laboratories, October 1982.

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