SUN MOON PHARMACEUTICALS PVT. LTD.

Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: OUT OF TRENDS
Department : Quality Assurance SOP No. : SOP/QA/009
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 1 of 2
Prepared By Reviewed By Approved By
Sign. with
Date.

1.0 OBJECTIVE:

To lay down the procedure to address the Out of Trends (OOT) Results at Sun Moon Pharmaceuticals
Pvt. Ltd.

2.0 SCOPE:

Procedure is applicable for the manufacturing facility of the Sun Moon Pharmaceuticals Pvt. Ltd.

3.0 RESPONSIBILITY:

In-charge – QC/ Designee-QC : Monitoring the results and raising OOT results.

Manager/Incharge/Designee-QC/Production/Maintenance: Investigate the OOT.

Manager – QA/Designee: Investigation and finalizing the root cause.

4.0 PRECAUTIONS:

NA

5.0 PROCEDURE:

1. OOT investigation will be carried out for the following cases,

a. If yield of any stage in product is varied by 10% from its standard output.
b. If Water analysis Microbial count is more than average results of CFU per mL and showing a
very high Microbial count.
c. If Powder Processing area’s results of the settling plates analysis is higher than average
value.
d. If the microbial contamination in the micro lab by settling plate is more than above average.

2. If OOT is with respect to the Yield, detail investigation shall be carried out.
3. If OOT is with respect to the Microbial contamination than area shall be cleaned with appropriate
method and the area Shall be fumigated.
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: OUT OF TRENDS
Department : Quality Assurance SOP No. : SOP/QA/009
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 2 of 2
Prepared By Reviewed By Approved By
Sign. with
Date.

4. Any observation of the OOT during the year shall be captured in the annual product quality review.
(APQR).

6.0 LIST OF ANNEXURES / ATTACHMENTS:

NA

7.0 ABBREVIATIONS:

SOP Standard Operating Procedure

NA Not Applicable
Sr. Serial
No. Number
CFU Colony Orming Unit

8.0 REFERENCE :

ICHQ7

9.0 SOP DISTRIBUTION:

Name of Department Department Code

Quality Assurance QA
Quality control QC
Production PD

10.0 REVISION AND HISTORY:

REV. NO. REASON FOR REVISION

00 New SOP

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.