SOP Title: Equipment/Instrument Calibration
- Objective:
To control, calibrate and maintain inspection, measuring and test equipments.
- Scope:
This procedure covers calibration of inspection, test and measuring equipments.
- Responsibility:
Executive, Officer, Chemist – Quality Assurance
- Accountability:
Head – QA/ Maintenance Head
- Procedure:
5.1 Definitions:
Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.
Concerned Department: Department in which the equipment or instrument is installed, operated and responsibility of calibration lies with.
5.2 Procedure:
| 5.2.1 | A list of measuring instruments to be calibrated from out side approved calibration agencies shall be prepared for outside calibration. | |
| 5.2.2 | Calibration Program: Calibration program shall include following aspects: | |
| 5.2.2.1 | Equipment/instrumentation used in the manufacture, processing, testing, packaging, and warehousing/distribution of drug product shall be included in a calibration program where appropriate.
Alarms, when functioning as the primary signal for identification of out of specification situations, must be periodically challenged at the measurement source. |
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| 5.2.2.2 | Calibration schedules shall be identified for each type of instrument. | |
| 5.2.2.3 | Written calibration procedures to describe calibration program shall include:
— Defined responsibilities. — Established acceptance criteria. — Range of use of instrument/equipment to include a minimum of three (3) point calibrations whenever feasible. — Provisions for management notification of out of calibration result (OOC). |
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| 5.2.2.4 | Provisions for investigation of out of calibration results shall include:
— Assessment of possible product impact. — Corrective actions. |
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| 5.2.2.5 | Identified calibration status of instrument/equipment. | |
| 5.2.2.6 | Outside contractor calibration shall include:
— Written contract or procedure to define scope and responsibilities of contractor service. — Calibration report reviewed and approved by authorized personnel. |
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| 5.2.3 | All the identified instruments shall have an identification number clearly marked on them. | |
| 5.2.4 | The status of calibration of measuring instruments shall be maintained. All entries shall be checked and signed. | |
| 5.2.5 | It shall be ensured that calibration is done as per relevant SOP at prescribed intervals and the records of calibration are maintained. | |
- Abbreviation:
| Abbreviation | Expansion |
| OOC | Out Of Calibration |
| SOP | Standard Operating Procedure |
| i.e. | Id Est (that is) |
| QAD | Quality Assurance Department |
*Note – Ready to use SOP available in “DOWNLOAD” Section.