SOP on Calibration of Production Instruments
Objective :To lay down a general procedure for calibration of production instruments.
Scope:This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location.
Responsibility
Production Supervisor / Officer shall be responsible for calibration of production instruments as per this SOP (For Instruments which shall be calibrated In-House).
Head-Production / designee shall ensure implementation of this SOP.
Head-Engineering / designee shall coordinate with outside agencies or suppliers for calibration of instruments.
Head production shall be responsible for compliance of this SOP.
Abbreviations and Definitions
SOP- Standard Operating Procedure
ID No. – Identification Number
QA – Quality Assurance
Procedure
Instruments associated with processing, monitoring and inprocess testing of products and areas shall be calibrated either by In-house procedure or by external authorized agencies as per Calibration Schedule (Annexure-1)
Instruments identified for calibration from external authorised agency shall be procedurised as per the SOP.
The instruments identified for In-house calibration shall be calibrated as per the specified frequency and the frequency is derived on the basis of criticality and usage.
The instruments to be calibrated In-house shall be calibrated as per following:
Calibration of in-house instrument shall be done as per respective SOP. Each Standard Operating Procedure for calibration of instrument shall discuss following minimum requirements.
Frequency of calibration of any instrument shall be designed based on criticality of its parameters or on manufacturer recommendations.
Acceptance Criteria of the calibrated instruments shall be in compliance with specifications of the respective instruments.
A specimen format shall be attachment as per respective instrument’s calibration SOP, for recording the observations.
Use of calibration standards traceable to National or International standards. These calibration standards shall be calibrated from out side agency in co-ordination with engineering department as per the SOP.
A label shall be attached to each instrument after calibration with status as ‘CALIBRATED’ status as per SOP.
If the instrument is out of calibration limit it shall be labelled as ‘Calibration Failed’ as per SOP and the corrective action shall be taken and the instruments shall not be used for production till the problem is rectified and instruments is re-calibrated. In case of internal calibration failure work order shall be raised by production to engineering department
Calibration record shall be kept for three years from the date of calibration.
Forms and Records
Calibration Schedule – Annexure-1
Distribution
Master Copy – Documentation Cell (QA)
Controlled Copies – Production, Quality Assurance and Engineering
History
| Date | Revision Number | Reason for revision |
| – | 00 | New SOP |
Annexure-I
| Calibration Schedule
(For Instruments From External Authorized Agencies) |
||
| S. No. | Name of Instruments | Frequency of Calibration |
| 1 | Ampere Meter | Annual |
| 2 | Conter/Rate Indicator | Annual |
| 3 | Counter Meter | Annual |
| 4 | Differential Pressure Transmitter | Annual |
| 5 | Digital Ampere Meter | Annual |
| 6 | Digital Proportional Integrated Derivative controller | Annual |
| 7 | Flow Meter | Annual |
| 8 | Hour Meter | Annual |
| 9 | Hygrometers | Annual |
| 10 | Linear Scale | Annual |
| 11 | Load Cell | Annual |
| 12 | Magnehelic Gauge | Annual |
| 13 | Manometer | Annual |
| 14 | Pressure Gauge | Annual |
| 15 | Pressure Switch | Annual |
| 16 | Pressure Transmitter | Annual |
| 17 | Relative Humidity/ Temperature Controller | Annual |
| 18 | Rotation Per Minute Meter | Annual |
| 19 | Temperature Transmitter(RTD) | Annual |
| 20 | Temperature Gauge | Annual |
| 21 | Vacuum Gauge | Annual |
| 22 | Conductivity Meter | Annual |
| 23 | Oxidation Reduction Potential Meter | Annual |
| 24 | Volt meter | Annual |
| 25 | Scale | Annual |
| 26 | Timer | Annual |
| 27 | Weight box( Up to 200 gm) | Annual |
| 28 | Digital hygro/Temperature meter | Annual |
| 29 | Vacuum Transmitter | Annual |
| 30 | Thickness Gauge | Annual |
| 31 | Multi meter | Annual |
| 32 | Level transmitter | Annual |
| 33 | Tachometer | Annual |
| 34 | Stop watch | Annual |
| 35 | Vernier caliper | Annual |
| 36 | Glass Thermometer | Annual |
| 37 | Dial Gauge | Annual |
| 38 | Thermostat | Annual |
| 39 | PH Meter | Annual |
| Calibration Schedule
(For Instruments Calibrated In-House) |
||
| S. No. | Name of Instruments | Frequency of Calibration |
| 1 | Analytical Weighing Balances | Daily |
| 2 | Weighing Balances | Once a Month |
| 3 | Disintegration Test Apparatus | Once a Month |
| 4 | Hardness Tester | Once a Month |
| 5 | Friability Test Apparatus | Once a Month |
| 6 | Halogen Moisture Analyzer | Six Months |
| 7 | PH Meter | Weekly |
