In-house Calibration of Weighing Scale SOP

In-house Calibration of Weighing Scale SOP

1.0   PURPOSE:

1.1.      To ensure Calibration of Weighing Scale at _________Pharmaceuticals.

2.0    SCOPE:

2.1.      This procedure applies to Calibration of Weighing Scale at ______ Pharmaceuticals  To fulfill GMP requirements , For accuracy and checking variances

3.0   RESPONSIBILITY:

3.1.      Quality Assurance Manager

3.2.      QA Officer

4.0    PRECAUTIONS:

4.1.1 Ensure power supply properly installed

4.1.2 Ensure proper installation (away from heat & air draft) on Solid base to avoid

         vibration during weighing.

4.1.3 Ensure balance pan & housing is clean.

4.0    PROCEDURE:

5.1.1.   Switch “ON” and check the zero adjustment of all Balances.

5.1.2.   Check the variance if any, and get it calibrated with the standard weights on

    each balance according to the weighing limits of Balance using:

 1-20 g Limit    (19.08 g--- 20.02 g)

2-50 g Limit    (49.05 g---50.05 g)

3-100g Limit   (99.90 g -----100.10 g)

4-1000g Limit  (999.90 g----1000.10 g)

4-5000g Limit (4999.5 g-----5000.50 g)

Record the reading on log Form  on daily basis.

5.1.3.   Get the variance checked if any, by Maintenance Department and adjust the

    balance.

5.1.4.   Ensure external calibration status is clearly indicated on calibration sticker

5.0     REVIEW FREQUENCY:

SOP will be reviewed at least annually.

6.0      RISK ANALYSIS:

EVIDENCES OF RECORDS & REFERENCES		Weighing Balance Calibration Log Sheet (F-07-016)
FORMAL KPIs (Key Performance Indicators)		Maintaining the record and availability of the record as and when required
GENERAL RISKS		CONTROL MEASURES	CUSTODIAN
Risks	Impact
Calibration Not done on Daily Basis Material Quantity not Weighed Properly according to Batch Size.	Product Quality Suffers.	Calibration should be Done on Daily Basis in the presence of QA Officer	QA Officer/ QA Attendant