QUALITY NEXGEN PHARMACEUTICAL

Page 1 of 2
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/CL-08
PROCEDURE FOR CLEANING OF Revision No 002
Title
MANUFACTURING AREA 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/CL-08
Distribution Supersedes
PRODUCTION
1. OBJECTIVE:
To provide a procedure for cleaning of Capsule Manufacturing Area.

2. SCOPE :
Covers the Cleaning of Manufacturing Area in Capsule Department.

3. RESPONSIBILITY
Cleaners, Production Chemist, Production In-charge.

4. PROCEDURE
4.1 After the completion of a batch, area is made clean for the commencement of next batch.
4.2 Remove all the previous product label.
4.3 Clean the Cone Blender as per S.O.P. No QN/CAP/CL-02
4.4 Clean thoroughly the walls, floor with soap solution and water respectively.
4.5 Clean the AHU filters.
4.6 De-dust the dirt collected on the light fixtures.
4.7 Walls & floor joints to be cleaned at the time of change over.
4.8 After cleaning, put the status label on each equipment and on the door.

5. PRECAUTION

5.1 Stop the activity and inform the Q.A In-charge incase of any unusual observation.

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/CL-08
PROCEDURE FOR CLEANING OF Revision No 002
Title
MANUFACTURING AREA 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/CL-08
Distribution Supersedes
PRODUCTION
6. RECORDS / SPECIMEN
6.1 Carry out the cleaning procedure as per above and enter in to the B.M.R.

7. FREQUENCY
At the time of product change over.

8. REVISION HISTORY
8.1 Revision History Table

SOP Number Effective Date Supersedes Brief description of change

QN/CAP/CL-08 01.04.2014 QN/CAP/CL-08 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