QUALITY NEXGEN PHARMACEUTICAL

Page 1 of 2
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/LIC-03
PROCEDURE FOR LINE CLEARANCE Revision No 002
Title OF SEMI AUTOMATIC CAPSULE
Issue Date 01.03.2016
FILLING MACHINE
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/LIC-03
Distribution Supersedes
PRODUCTION
1. OBJECTIVE:
To provide guidelines to ensure effective line clearance of the area and Semi automatic capsule filling
machine.

2. SCOPE :
Applicable to documents, equipment, cleanliness and labeling of Semi automatic capsule filling machine
used during capsule filling process.

3. MAKE AND CAPACITY:

Cap-Tech Engineers.
Pacific Technologies.

4. RESPONSIBILITY
Production Chemist / Production Manager & Operator.

5. PROCEDURE
5.1 Ensure that all the containers, labels and documents of previous batch / product has been removed.
5.2 Ensure that the blender is cleaned as per S.O.P. QN/CAP/CL-03 for product change over and for
batch change over.
5.3 Ensure that area is cleaned as per S.O.P. QN/CAP/GEN-01
5.4 Ensure that appropriate label is fixed on the machine.
5.5 Ensure that no traces of previous product should be found by taking swab test.

6 PRECAUTION
6.1 Line Clearance is given by Q. A. Officer to start the next batch, after checking the above
PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. MANAGER QA MANAGER PLANT MANAGER
 QUALITY NEXGEN PHARMACEUTICAL
Page 2 of 2
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/LIC-03
PROCEDURE FOR LINE CLEARANCE Revision No 002
Title OF SEMI AUTOMATIC CAPSULE
Issue Date 01.03.2016
FILLING MACHINE
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/LIC-03
Distribution Supersedes
PRODUCTION

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 from product to product.

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. MANAGER QA MANAGER PLANT MANAGER