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Gamp Calibration

The document provides guidance on calibration management requirements for pharmaceutical manufacturers. It aims to help them develop and implement an effective calibration strategy for any instruments used. Key requirements include defining calibration methods, frequencies and limits for each critical instrument. Instruments must be assessed for criticality to determine calibration needs. Calibration records must be maintained and include requests, certificates, and non-conformance reports. The goal is to ensure process and measurement accuracy through proper instrument calibration.

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Mevada Panakaj
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201 views4 pages

Gamp Calibration

The document provides guidance on calibration management requirements for pharmaceutical manufacturers. It aims to help them develop and implement an effective calibration strategy for any instruments used. Key requirements include defining calibration methods, frequencies and limits for each critical instrument. Instruments must be assessed for criticality to determine calibration needs. Calibration records must be maintained and include requests, certificates, and non-conformance reports. The goal is to ensure process and measurement accuracy through proper instrument calibration.

Uploaded by

Mevada Panakaj
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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GAMP Good Practices Guide: Calibration management requirements

The GAMP forum is a body formed in 1991 primarily to promote the understanding of
pharmaceutical computer-controlled systems.

The “Calibration Management” Good Practices Guide (Jan 2002) is the first document released
by the GAMP forum that aims to assist pharmaceutical manufacturers in both devising and
managing a good calibration strategy. This document focuses on the requirements of the
pharmaceutical manufacturers and offers a path to them to implement a calibration management
strategy. The scope of the document is for any instrument, which is employed by a
pharmaceutical manufacturer.

The key message of the document is “that with good control and prioritisation of instrument
calibration, there is a high degree of confidence that the [manufacturing] process has remained
within the desired range and the accuracy of measurement has been maintained within
tolerances.”

Key Pharmaceutical Requirements for Critical Instruments

The key pharmaceutical requirements for critical instruments are that they meet the following
criteria:

• Each instrument should have a record in a permanent master history file.

• All instruments are assigned a unique number and are tagged with that number.

• The calibration method should be defined and approved.

• Calibration frequency and process limits should be defined for each instrument.

• The calibration status should be identified on the instrument (status sticker).

• All records shall be maintained.

• All and any electronic records must meet 21 CFR Part 11.

• The calibration standards must be more accurate to a closer tolerance than the
instrument being tested.

• Each standard must be traceable to a recognized standard.

• All instruments must be fit for purpose.

• Training records for all personnel involved in the calibration must be maintained.

• A change control system must be in place.

• The instruments must meet all GMP requirements, as defined by the relevant regulatory
agency (FDA, TGA or MHRA).

Instrument Criticality Assessment

All instruments directly, or indirectly, involved with the process should be individually assessed for
their criticality to the process.

Category Definition
Product critical instrument An instrument whose failure may have a direct impact on
product quality.

Process / system critical An instrument whose failure may effect the process or system
instrument performance but does not directly impact product quality.

Safety / environmental critical An instrument whose failure may effect either safety or the
instrument environment.

Non-critical instrument. An instrument whose failure has no impact on product quality,


systems or the environment.

Determining Calibration Frequency

Frequency of calibration is determined by the following factors:


• Manufacturers recommendations (refer to the manual)
• Consequence of calibration failure (the risk)
• Uitilisation of the instrument
• Relevant standards and regulations
• Historical reliability
• Experience of users

In general, critical instruments should be recalibrated every 6 months until sufficient data allows
for annual calibrations to be performed. Non-critical instruments may only require periodic checks
on performance and not require calibration. Critical instruments may warrant daily performance
checks.

Non-Conformance Investigation

These are performed when the ‘as found’ data lies outside of acceptable drift. The following
should be done when a sensor raises an non-compliance report.
• Sensor marked as ‘OUT OF CALIBRATION’
• Failure logged
• Non-conformance report generated
• Actions defined for repair
• QA informed and investigation to recall or reject product
•
Calibration Records

All calibration records must be unambiguous and be readily available, a unique number must
identify the document. Any instrument removal should be documented and the replacement has a
full documented history. The removed instrument should be calibrated immediately to ascertain
the cause or impact of failure. The following is a list of key documents plus the content for each
document.

Calibration Request

• Scheduled date for calibration and frequency


• Instrument ID
• Calibration range
• Special instructions
• Accuracy and failure limits

Certificate of Calibration

• Reference to Calibration Request


• Instrument ID
• All test hardware and traceability
• Calibration range
• Calibration accuracy and failure limits
• "As found" and "as left" data
• Instrument status (PASS/FAIL)
• Calibrator and approver
• Combination of errors / uncertainties
• All calculations and corrections
• Environmental data

Non-Conformance Report

• Unique ID for instrument


• Failure or errors leading to the non-conformance
• Actions for repair
• Final approval

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