OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN

SOP No.:
QUALITY CONTROL DEPARTMENT Page 1 of 3
QCG0016
Supersedes : Effective:
STANDARD OPERATING PROCEDURE
00 April 2010

Version No. : SOP FOR OPERATION AND CALIBRATION OF Review date:
01 FRIABILITY TEST APPARATUS March 2013

1.0 OBJECTIVE:

To describe the procedure for the “Operation and Calibration Friability
Test Apparatus”.

2.0 SCOPE:

This SOP is applicable to “Calibration of Friability Test Apparatus” at M/s.
Oasis Laboratories Private Limited, Dehradun.

3.0 RESPONSIBILITY:

Quality Control Department

4.0 ACCOUNTABILITY:

HOD – QC

5.0 PROCEDURE :

5.1 Ensure that the instrument and its surrounding area is clean and
free from dust.

5.2 Weigh accurately the number of tablets and carry out the
procedure as described in the monogram.

5.3 Open the apparatus from one removable side of the drum.
5.4 Transfer the tablets in it and close the drum tightly.

5.5 Switch on the apparatus, and count the revolution as specified in
the monogram.

5.6 The tablets are tumbled at each turn of the drum by a curved
projection that extends from the middle of the drum to the outer
wall.

5.7 Rotated the drum 100 times, and after completion of revolution
remove the tablets from the drum.
5.8 Remove any loose dust or broken tablets and weigh.

Designation Signature Date
Prepared by Chemist - QC
Reviewed by Manager - QC
Approved by Manager - QA

QA . DEHRADUN SOP No.00 min ±0.QC Approved by Manager . Dept.QC Reviewed by Manager .9 Switch of the instrument when not required.” 9. : Department. 8. 6.0 CALIBRATION RECORD:- The apparatus is calibrated by TIME CONTROLLER and calculate RPM as follows:- PROCEDURE:- Calibration of RPM Calibration of Time Controller Set No of Observed Set observed / Date Limit Limit Time revolution RPM/min. QC : Quality Control Annexure-1 CALIBRATION OF FRIABILITY TEST APPARATUS Designation Signature Date Prepared by Chemist .05 min 0 – 8 min ±1 RPM 15.00 min ±0. : SOP FOR OPERATION AND CALIBRATION OF Review date: 01 FRIABILITY TEST APPARATUS March 2013 5. time Display time 0 – 4 min ±1 RPM 5. HOD : Head of the Department.05 min 4 – 8 min ±1 RPM 10.05 min Frequency of calibration: Monthly 7.00 min ±0.0 ABBREVIATIONS & DEFINITIONS: SOP : Standard Operating Procedure.0 RECORDS: “Calibration Record of Friability Test Apparatus” (Annexure-1). OASIS LABORATORIES PRIVATE LIMITED.: QUALITY CONTROL DEPARTMENT Page 2 of 3 QCG0016 Supersedes : Effective: STANDARD OPERATING PROCEDURE 00 April 2010 Version No.0 ANNEXURES: Annexure-1: Format for “Calibration Record of Friability Test Apparatus.

05 min min 0 – 8 min ±1 RPM 15.QC Approved by Manager .00 ±0.00 ±0. Name of Manufacturer : Satish Enterprises Delhi Instrument ID Number : QC/CS/016 Frequency of calibration : Monthly Calibration of RPM Calibration OF TIME CONTROLLER Next Remark Performed Checked due by by Date Set No of Observed Limit Set observed / Limit date Time revolution RPM/min.05 min min Designation Signature Date Prepared by Chemist .00 ±0.C. DEHRADUN SOP No.: QUALITY CONTROL DEPARTMENT Page 3 of 3 QCG0016 Supersedes : Effective: STANDARD OPERATING PROCEDURE 00 April 2010 Version No. OASIS LABORATORIES PRIVATE LIMITED.QA . time Display time 0 – 4 min ±1 RPM 5.QC Reviewed by Manager . : SOP FOR OPERATION AND CALIBRATION OF Review date: 01 FRIABILITY TEST APPARATUS March 2013 SOP REF NO – QCG0016 QC-F-019-01 Name of Instruments : Friability Test Apparatus Instruments location: Q. LAB.05 min min 4 – 8 min ±1 RPM 10.

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