QUALITY NEXGEN PHARMACEUTICAL

Page 1 of 2
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/LIC-01
PROCEDURE FOR LINE CLEARANCE Revision No 002
Title
OF VIBRATORY SIFTER Issue Date 01.03.2016
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/LIC-01
Distribution Supersedes
PRODUCTION
1. OBJECTIVE:
To provide guidelines to ensure effective Line Clearance of the area and Vibrator Sifter.

2. SCOPE :
Applicable to documents, materials, equipments, cleanliness and labeling of sifting area of capsule
department used during sifting R.M.

3. MAKE AND CAPACITY:

Global Pharma “30”

4. RESPONSIBILITY
Production Chemist / Production Manager & Operator.

5. PROCEDURE
5.1 Check that all the containers, labels and documents of previous batch / product are removed and
status board is properly written.
5.2 Ensure that sifter is cleaned as per S.O.P. QN/CAP/CL-01.
5.3 Ensure that the hopper, gasket, sieve-holding ring, body are properly cleaned.
5.4 Ensure that area is cleaned as per S.O.P. QN/CAP/GEN-01.
5.5 Ensure that appropriate label is fixed on equipment.
5.6 Check the integrity of sieve as per Batch Manufacturing Record.
5.7 Ensure that sieve is properly fixed by inching the machine. (No abnormal sound should come
from machine).
5.8 Ensure that no traces of previous product should be found by taking swab test.
5.9 Line clearance is given by Q. C. Officer to start the next batch, after checking the
above-Mentioned points, which is to be recorded in the BMR.

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. IN CHARGE QA MANAGER PLANT MANAGER
 QUALITY NEXGEN PHARMACEUTICAL
Page 2 of 2
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/LIC-01
PROCEDURE FOR LINE CLEARANCE Revision No 002
Title
OF VIBRATORY SIFTER Issue Date 01.03.2016
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/LIC-01
Distribution Supersedes
PRODUCTION
6 PRECAUTION
6.1 Line Clearance is given by Q. C. Officer to start the next batch, after checking the above
mentioned points which is to be recorded in the BMR.

7 RECORDS / SPECIMEN

7.1 Records the results in the

Line Clearance

8. FREQUENCY
At the time of change over.

9. REVISION HISTORY
9.1 Revision History Table

SOP Number Effective Date Supersedes Brief description of change

QN/CAP/LIC-01 01.04.2016 QN/CAP/LIC-01 1] Change in Format.
2] Added History,
Precaution, Frequency,
Records and Revision
History table in SOP.

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. IN CHARGE QA MANAGER PLANT MANAGER