Beamex® CMX Calibration Software andGAMP - Good Automated Manufacturing Practices

• The GAMP Forum was established in 1991 to help promote the understanding of how computer systems validation should be carried out in the pharmaceutical industry.

• Calibration is an essential element in ensuring compliance in the pharmaceutical industry. To ensure success, calibration should be managed effectively by appropriately qualified personnel with good technical knowledge and practical understanding. If neglected, calibration is capable of compromising both production and plant, and dramatically increasing costs.

GAMP Good Automated Manufacturing Practices

Key Definitions

Calibration“The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard”.

Validation“Action of providing, in accordance with the principles of Good Manufacturing Practices (GMP), that any procedure, process, equipment, material, activity or system actually leads to the expected results”.

Qualification“Action of proving that any equipment works correctly and actually leads to the expected results. The world ‘validation’ is sometimes widened to incorporate the concept of qualification”.

(Rules and Guidance for Pharmaceutical Manufacturers and Distributors, MAC, 1997)

Responsibilities

Process OwnersTo identify the critical parameters, the process variables, and to derive acceptable limits.

Quality Assurance (QA)To verify the limits are acceptable and ensure that parameters meet regulatory compliance.

EngineeringTo propose the use of suitable instrumentation and asses whether instruments are fit for propose.

Key Regulatory Requirements

1. Each instrument should have a permanent master history record.

2. All instrumentation should be assigned a unique number and all product, process, and safety critical instruments should be physically tagged.

3. The calibration method should be defined by approved procedure.

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

5. There should be a means of readily determining the calibration status of each instrument.

6. Calibration records should be maintained.

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Key Regulatory Requirements

6. All electronic systems used for calibration management for systems, which affects products for supply to the USA must comply with the Food and Drug Administration (FDA) “21 CFR Part 11 – Electronic Records, Electronic Signatures”.

8. Calibration measuring standards should be more accurate than the required accuracy of the instrument that is being used.

9. Each measuring standard should be traceable to a nationally, or internationally, recognized standard, where one exists.

10. All instruments used should be fit for propose.

11. There should be documented evidence that personnel involved in the calibration process have been trained and are competent.

12. A documented change management system should be established.

Master History Record

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Assign a Unique Instrument Number

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Approved Procedure

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Calibration Frequency

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Process Limits

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The Calibration Status

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Calibration Records

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21 CFR Part 11 – ER, ES

• The FDA’s view is that the risk of falsification, misinterpretation, and change without leaving evidence are higher with electronic records than paper records, and that therefore specific controls are required.

Key Regulatory Requirements

• Technology, System should allow applicable electronic data to be accessed in human readable form. System should be able to maintain applicable electronic data over periods of many years.

• Security, System should restrict use of system functions and features in accordance with configurable rules that can be maintained. System should force to give unique electronic signature when electronic record is created, modified or deleted.

• Audit Trail, System should be able to identify changes to electronic record in order to detect invalid or altered records.

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Standard More Accurate than Instrument

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Standard Should be Traceable

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Instruments Used Should be Fit for Propose

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Personnel Trained and Competent

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Documented Change Management

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Accessed in Human Readable Form

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Restrict Use of System Functions

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Electronic Signature

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Identify Changes to Electronic Record

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