QUALITY NEXGEN PHARMACEUTICAL

Page 1 of 2
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/CLV-01
PROCEDURE FOR CLEANING Revision No 002
Title
VALIDATION 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/CLV-01
Distribution Supersedes
PRODUCTION
1. OBJECTIVE:
To provide a procedure for cleaning validation of vibratory sifter.

2. SCOPE :
Covers the effectiveness of cleaning to avoid cross contamination

3. RESPONSIBILITY
Production chemist, Production In-charge, Q.A. officer

4. PROCEDURE
4.1 Clean the double vibratory sifter as per the S.O.P. NO. QN/CAP/CL-01
4.2 Collect the water sample from the final rinse in a clean glass apparatus (beaker /conical
flask) and give to the Q.C. laboratory for testing (water change over.)
4.3 The test carried out are – Description
Absence of the active ingredient
4.4 Record the observations
4.5 Inspect the equipment visually for cleanliness

5. PRECAUTION

5.1 Incase of any unusual observation, stop the activity and inform the Q.A. department.

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/CLV-01
PROCEDURE FOR CLEANING Revision No 002
Title
VALIDATION 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/CLV-01
Distribution Supersedes
PRODUCTION

6. RECORDS/ SPECIMEN
6.1 Records the results in the

Cleaning validation Record

7. REVISION HISTORY
7.1 Revision History Table

SOP Number Effective Date Supersedes Brief description of change

QN/CAP/CLV-01 01.04.2016 QN/CAP/CLV-01 1] Change in Format.
2] Added History,
Precaution, 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