PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.

Rupshi,Narayanganj,Bangladesh
LIST OF STANDARD OPERATING PROCEDURE (SOP)

SL. Title Document No. Rev. Effective

No No. Date
SOP FOR QA
1.0 PROCEDURE FOR PREPARATION AND HANDLING OF STANDARD SOP/NP/QA/001 03 09 Sep. 2017
OPERATING PROCEDURE (SOP)
2.0 DOCUMENT NUMBERING SYSTEM SOP/NP/QA/002 03 10 Feb 2015
3.0 HANDLING OF PRODUCT COMPLAINT SOP/NP/QA/003 03 13 Jan. 2015
4.0 SOP FOR TRAINING SOP/NP/QA/006 01 09 sep.2017
5.0 WASTE MANAGEMENT SOP/NP/QA/008 03 10 Feb 2015
6.0 SAMPLING OF INTERMEDIATE, BULK, FINISHED & RETENTION SOP/NP/QA/015 03 29 Dec. 2014
SAMPLE
7.0 DEVIATION MANAGEMENT SOP/NP/QA/016 02 21 Sep. 2016
8.0 PRODUCT RECALL PROCEDURE SOP/NP/QA/017 00 14 Jan. 2015
9.0 SELF-INSPECTION SOP/NP/QA/019 03 20 Sep. 2014
10.0 CORRECTIVE ACTION AND PREVENTIVE ACTION SOP/NP/QA/021 00 23 Jan. 2016
11.0 ANNUAL PRODUCT REVIEW SOP/NP/QA/022 05 30 Jan.2017
12.0 SOURCE APPROVAL PROCESS SOP/NP/QA/023 00 06 Jan 2016
13.0 DOCUMENT GENERATION & CONTROL SOP/NP/QA/024 00 10 Feb 2015
14.0 CHANGE CONTROL MANAGEMENT SOP/NP/QA/025 04 11 Oct. 2017
15.0 PEST CONTROL PROCEDURE SOP/NP/QA/029 02 17 sep.2017
16.0 FUNCTION OF QUALITY ASSURANCE SOP/NP/QA/031 00 20 Jan 2015
17.0 STANDARD OPERATING PROCEDURE FOR BALANCE CALIBRATION SOP/NP/QA/032 00 25 Aug 2015
18.0 LOG BOOK CONTROL AND MANAGEMENT SOP/NP/QA/035 02 10 Oct.2017
SOP FOR QA (HEALTH CARE)
1.0 DOCUMENT NUMBERING SYSTEM SOP/NHCL/QA/002 01 10 Feb 2015
2.0 CHANGE CONTROL MANAGEMENT SOP/NHCL/QA/003 04 02 July 2017
3.0 BATCH RECORD REVIEWING,ARCHIVING AND CONTROLLING SOP/NHCL/QA/005 02 17 Sep 2014
4.0 WASTE MANAGEMENT SOP/NHCL/QA/007 02 17 Sep 2014
5.0 RELEASE OF FINISHED PRODUCT SOP/NHCL/QA/009 03 25 Jan 2017
6.0 SOP FOR TRAINING SOP/NHCL/QA/014 01 10 Feb 2015
7.0 SAMPLING OF INTERMEDIATE,BULK,FINISHED & RETENTION SOP/NHCL/QA/015 01 11 Jan.2017
SAMPLE
8.0 HANDLING OF PRODUCT COMPLAINT SOP/NHCL/QA/019 03 02 Dec. 2014
9.0 DEVIATION MANAGEMENT SOP/NHCL/QA/022 02 8 Nov. 2016
10.0 USE OF STATUS LABEL SOP/NHCL/QA/024 01 24 April 2017
11.0 SELF-INSPECTION SOP/NHCL/QA/025 01 26 Apr 2017
12.0 PEST CONTROL PROCEDURE SOP/NHCL/QA/026 01 24 April 2017
13.0 CONTROL OF PACKAGING MATERIAL SOP/NHCL/QA/027 00 26 Apr 2014
14.0 DOCUMENT GENERATION & CONTROL SOP/NHCL/QA/030 00 10 Feb 2015
15.0 CORRECTIVE ACTION AND PREVENTIVE ACTION SOP/NHCL/QA/033 00 23 Jan 2016
16.0 STANDARD OPERATING PROCEDURE FOR BALANCE CALIBRATION SOP/NHCL/QA/034 01 02 Feb.2016
17.0 LOG BOOK CONTROL AND MANAGEMENT SOP/NHCL/QA/035 01 11 June 2017

Prepared by : Checked by : Approved by :

Name Nargis Sultana Ayesha Zaman Deb Narayan Biswas
Designation Executive, PD Manager, PD DGM,QA
Signature & Date
Page 1 of 1
 PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.
Rupshi,Narayanganj,Bangladesh
LIST OF STANDARD OPERATING PROCEDURE (SOP)

SL. Title Document No. Rev. Effective

No. No. Date

SOP FOR ADMIN

1.0 FIRST AID PROCEDURE SOP/NP/ERA/001 01 02 Nov 2014
2.0 TRANSPORT MANAGEMENT SOP/GEN/ERA/002 01 5 May 2015
3.0 LAUNDRY PROCEDURE SOP/NP/ERA/003 00 02 Nov 2014
4.0 FOOTWEAR CLEANING PROCEDURE SOP/NP/ERA/004 00 02 Nov 2014
5.0 FACTORY SECURITY PROCEDURE SOP/NP/ERA/005 00 05 May 2015
6.0 MEDICAL EXAMINATION SOP/NP/ERA/007 00 05 May 2015
7.0 INDUCTION OF NEW EMPLOYEES SOP/NP/ERA/008 00 05 May 2015
8.0 COMPANY POLICY OF VISITOR SOP/NP/ERA/010 00 05 May 2015
9.0 HANDLING OF COMPANY UNIFORM SOP/NP/ERA/012 01 05 May 2015
10.0 PROCEDURE FOR CHANGING EMPLOYEE WHO IS SUFFERING SOP/NP/ERA/013 00 05 May 2015
FROM CONTAGIOUS/INFECTIOUS DISEASE
11.0 HOUSE KEEPING PROCEDURE SOP/NP/ERA/015 00 05 May 2015
12.0 SINK & FLOOR DRAIN SANITATION SOP/NP/ERA/016 00 05 May 2015
13.0 PERSONNEL HEALTH & HYGIENE PROCEDURE SOP/NP/ERA/017 01 03 April 2016
14.0 ENTRY AND EXIT PROCEDURE FOR RESTRICTED AREA SOP/NP/ERA/018 00 05 May 2015

SL. Title Document No. Rev Effective

Prepared by : Checked by : Approved by :

Name Nargis Sultana Ayesha Zaman Deb Narayan Biswas
Designation Executive, PD Manager, PD DGM,QA
Signature & Date
Page 1 of 1
 PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.
Rupshi,Narayanganj,Bangladesh
LIST OF STANDARD OPERATING PROCEDURE (SOP)

No. . Date
No.
SOP FOR PMD
1.0 ADVERSE DRUG EVENT REPORT SOP/NP/PMD/001 00 26 Dec 2016
2.0 ADVERSE DRUG EVENT REPORT SOP/NHCL/PMD/002 00 26 Dec 2016

SL. Title Document No. Rev. Effective

Prepared by : Checked by : Approved by :

Name Nargis Sultana Ayesha Zaman Deb Narayan Biswas
Designation Executive, PD Manager, PD DGM,QA
Signature & Date
Page 1 of 1
 PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.
Rupshi,Narayanganj,Bangladesh
LIST OF STANDARD OPERATING PROCEDURE (SOP)

No. No Date
SOP FOR PRODUCTION
1.0 GENERAL GUIDELINE FOR RECEIVED, STORAGE AND SOP/PPIC/001 00 29 NOV 2014
CONTROLLING OF BMR & BPR
2.0 GENERAL GUIDELINE FOR PRODUCTION PLANNING AND SOP/NP/PPIC/002 00 01 Apr 2015
MATERIALS REQUIRMENT
3.0 OPERATION AND CLEANING PROCEDURE OF GFG-120 HIGH SOP/NP/ TAB /005 03 24 Mar 2015
EFFICIENT FLUID BED DRYER
4.0 OPERATION AND CLEANING PROCEDURE OF DOUBLE CONE SOP/NP/ TAB /006 05 14 Nov.2016
BLENDER
5.0 OPERATION AND CLEANING PROCEDURE OF THAI COATER SOP/NP/ TAB /007 05 20 Nov.2016
6.0 OPERATION AND CLEANING PROCEDURE OF NR COATER SOP/NP/ TAB /008 03 19 Nov.2016
7.0 OPERATION AND CLEANING PROCEDURE OF BGB-80 COATER SOP/NP/ TAB /009 01 24 Mar 2015
8.0 OPERATING & CLEANING PROCEDURE OF TABLET COMPRESSION SOP/NP/ TAB /010 03 4 Dec.2016
STATION-20
9.0 OPERATING & CLEANING PROCEDURE OF TABLET COMPRESSION SOP/NP/ TAB /011 03 4 Dec.2016
STATION-25
10.0 OPERATING & CLEANING PROCEDURE OF TABLET COMPRESSION SOP/NP/ TAB /012 03 4 Dec.2016
STATION-27
11.0 OPERATION & CLEANING PROCEDURE OF FLUID BED DRYER (SAI- SOP/NP/ TAB /014 00 25 jan.2017
120 )
12.0 OPERATION & CLEANING PROCEDURE OF PASTE PREPARATION SOP/NP/ TAB /015 00 24 Dec 2014
KETTLE
13.0 PASTE PREPARATION PROCEDURE SOP/NP/ TAB /021 00 24 Dec 2014
14.0 INSPECTION AND HANDLING OF SEIEVE AND SCREENS SOP/NP/ TAB /022 00 21 Dec 2014
15.0 THE OPERATION OF CLEANING PROCEDURE OF HORIZONTAL SOP/NP/LIQ/008 01 24 Jan.2017
FILTER PRESS MACHINE
16.0 THE OPERATION OF CLEANING PROCEDURE OF LIQUID AUTO SOP/NP/LIQ/010 00 17 Jan.2017
ADHESIVE LABELING
17.0 THE OPERATION OF CLEANING PROCEDURE OF LIQUID AUTO SOP/NP/LIQ/011 00 17 Jan.2017
CAP SEALING MACHINE
18.0 THE OPERATION OF CLEANING PROCEDURE OF COLLOID MILL SOP/NP/LIQ/013 00 24 Jan .2017
MACHINE
19.0 CLEANING PROCEDURE OF MULTIMILL SOP/NP/ PFS/005 03 08 Jan.2017
20.0 OPERATION OF CLEANING PROCEDURE OF PFS PP CAP SOP/NP/ PFS/007 00 24 Jan.2017
SEALINGMACHINE
21.0 OPERATION & CLEANING PROCEDURE OF VACUUM MIXING SOP/NP/ COG/001 00 05 Jul.2017
EMULSIFIER
22.0 OPERATION & CLEANING PROCEDURE OF TUBE FILLING AND SOP/NP/ COG/002 00 05 Jul.2017
SEALING MACHINE
23.0 OPERATION & CLEANING PROCEDURE OF BLISTER SOP/NP/ PROD /014 01 19 Nov 2014
MACHINE(HOONGA 1)
24.0 PERSONNEL PRACTICE SOP/NP/ PROD /016 00 25 Aug 2013
25.0 PLANNED DEVIATION OF BATCH SIZE SOP/NP/ PROD /020 00 21 Aug 2013

Prepared by : Checked by : Approved by :

Name Nargis Sultana Ayesha Zaman Deb Narayan Biswas
Designation Executive, PD Manager, PD DGM,QA
Signature & Date
Page 1 of 1
 PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.
Rupshi,Narayanganj,Bangladesh
LIST OF STANDARD OPERATING PROCEDURE (SOP)

26.0 BATCH NUMBERING SOP/NP/ PROD /022 01 25 Oct 2014

27.0 OPERATION & CLEANING PROCEDURE OF BLISTER SOP/NP/ PROD /034 01 19 Nov 2014
MACHINE(HOONGA 2)
28.0 REWORK PROCEDURE SOP/NP/ PROD /038 00 27 Dec 2014
29.0 PACKAGING PROCEDURE SOP/NP/ PROD /040 02 26 Nov 2016
30.0 OPERATION & CLEANING PROCEDURE OF STRIP MACHINE SOP/NP/ PROD /041 02 14 Dec 2016
31.0 COLLECTION, SORTING, TIME PHASE & USE OF RECOVERY FROM SOP/NP/ PROD /045 00 23 Nov 2014
PRODUCT LEFT OVER OF BATCH
32.0 EXPOSING OF UV LIGHT SOP/GEN/PROD/016 01 15 June 2013
33.0 WASTE MANAGEMENT,STORAGE AND DISPOSAL SOP/GEN/PROD/017 01 15 June 2013
34.0 OPERATING AND CALIBRATION PROCEDURE OF ELECTRONIC SOP/GEN/PROD/019 01 15 June 2013
BALANCE (MODEL:UX420H)
35.0 HANDLING OF PROBLEM DURING PROCESSING SOP/GEN/PROD/020 01 15 June 2013
36.0 HOUSE KEEPING SOP/GEN/PROD/021 01 15 June 2013
37.0 OPERATING AND CLEANING PROCEDURE OF LAMINER AIR FLOW SOP/GEN/PROD/030 01 15 June 2013
UNIT (L.A.F)
38.0 SOP FOR FILTRATION UNIT CLEANING AND MAINTENANCE OF SOP/SVPO/PROD/002 01 15 June 2013
FILTER
39.0 STANDARD OPERATING PROCEDURE OF FILTER INTEGRITY TEST SOP/SVPO/PROD/004 01 15 June 2013

40.0 OPERATION & CLEANING PROCEDURE OF DHS(DRY HEAT SOP/SVPO/PROD/005 01 15 June 2013
STERILIZER)
41.0 OPERATING AND CLEANING PROCEDURE OF SEMI-AUTOMATIC SOP/SVPO/PROD/006 01 15 June 2013
LIQUID VIAL/BOTTLE FILLING AND SEALING MACHINE.
42.0 OPERATING AND CLEANING PROCEDURE OF AUTOMATIC SOP/SVPO/PROD/007 01 15 June 2013
AMPOULE FILLING AND SEALING MACHINE
43.0 OPERATING AND CLEANING PROCEDURE OF SEMI AUTOMATIC SOP/SVPO/PROD/008 01 15 June 2013
EYE DROP FILLING AND OVER CAPPING
MACHINE(STEROID/NON-STEROID)
44.0 SOP FOR STERILE SOLUTION PROCESSING SOP/SVPO/PROD/009 01 15 June 2013
45.0 PREVENTING CROSS CONTAMINATION FOR MANUFACTURING SOP/SVPO/PROD/011 00 June 30,2013
OF STEROIDAL AND NONSTEROIDAL PRODUCTS AT SAME
PREMISES
46.0 FUNCTION OF PRODUCTION DEPARTMENT SOP/NHCL/PROD/034 00 25 Feb 2015
47.0 FUNCTION OF WAREHOUSE DEPARTMENT SOP/NHCL/WH/014 00 22 Apr 2015

Prepared by : Checked by : Approved by :

Name Nargis Sultana Ayesha Zaman Deb Narayan Biswas
Designation Executive, PD Manager, PD DGM,QA
Signature & Date
Page 1 of 1
 PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.
Rupshi,Narayanganj,Bangladesh
LIST OF STANDARD OPERATING PROCEDURE (SOP)

SL. Title Document No. Rev.No. Effective Date

No.
SOP for PRODUCT DEVELOPMENT
1.0 NEW PRODUCT DEVELOPMENT SOP/NP/PD/001 05 15 Dec 2014
2.0 STABILITY STUDY SOP/NP/PD/002 07 24 Apr 2017
3.0 PROCESS VALIDATION SOP/NP/PD/003 04 24 Apr 2017
4.0 APPROVAL OF NEW SOURCE OF RAW MATERIAL SOP/NP/PD/004 04 07 Feb.2016
5.0 PREPARATION OF BATCH MANUFACTURING RECORD (BMR)& SOP/NP/PD/005 01 27 Jan. 2016
BATCH PACKING RECORD(BPR)
6.0 OPERATION OF HIGH PERFORMANCE LIQIUD SOP/NP/PD/006 01 23 Sep 2017
CHROMATOGRAPHY DIONEX ULTIMATE 3000
7.0 OPERATION AND CLEANING PROCEDURE OF CONVENTIONAL SOP/NP/PD/007 02 26 Sep 2017
COATING MACHINE
8.0 OPERATION AND CALIBRATION OF HUMIDITY CONTROL OVEN, SOP/NP/PD/008 02 01 Feb .2017
MODEL NO. NEC-221R10S
9.0 OPERATION AND CLEANING PROCEDURE OF TRAY DRYER(Model: SOP/NP/PD/009 02 26 Sep 2017
YS-AD9)
10.0 OPERATION AND CLEANING PROCEDURE OF MINI DOUBLE CONE SOP/NP/PD/010 02 26 Sep 2017
BLENDER
11.0 REQUISITION OF RAW/PACKAGING MATERIAL FROM STORE SOP/NP/PD/011 01 31 Dec. 2014
12.0 VALIDATION OF ANALYTICAL TEST PROCEDURE SOP/NP/PD/012 01 15 Jan 2017
13.0 OPERATION & CALIBRATION OF pH METER(HI 2211 pH/ORP SOP/NP/PD/013 01 31 May 2017
METER)
14.0 OPERATION AND CALIBRATION OF DISINTEGRATION TEST SOP/NP/PD/014 01 23 Sep.2017
APPARATUS
15.0 OPERATION AND CALIBRATION OF ELECTRONIC BALANCE SOP/NP/PD/015 01 26 Sep.2017
( SHIMADZU TX223L)
16.0 WASTE MANAGEMENT SOP/NP/PD/016 01 26 Sep 2017
17.0 OPERATION & CLEANING OF LAB PRESS-II TABLET COMPRESSION SOP/NP/PD/017 00 14 Dec 2014
MACHINE(PHARMACHINE INDIA)
18.0 OPERATION & CALIBRATION OF DISSOLUTION TEST SOP/NP/PD/018 00 02 Mar 2015
APPARATUS(ELECTROLAB EDT-08LX)
19.0 TECHNOLOGY TRANSFER SOP/NP/PD/019 00 02 Dec 2015
20.0 MANAGEMENT OF HPLC COLUMN SOP/NP/PD/020 00 10 May 2015
21.0 OPERATION OF WALK IN TYPE STABILITY CHAMBER,MODEL:GMP SOP/NP/PD/021 00 07 Dec 2015
& CAPACITY :3000 L
22.0 OPERATION OF STABILITY CHAMBER, MODEL:GMP & SOP/NP/PD/022 00 07 Dec 2015
CAPACITY :1000 L
23.0 CODING SYSTEM OF RAW MATERIAL AND PACKING MATERIAL SOP/NP/PD/023 01 23 April 2017
24.0 PRODUCT MASTER FILE COMPILATION SOP/NP/PD/024 00 09 Oct,2016
25.0 OPERATION AND CALIBRATION OF UV Spectrophotometer SOP/NP/PD/025 02 22 March,
2017

Prepared by : Checked by : Approved by :

Name Nargis Sultana Ayesha Zaman Deb Narayan Biswas
Designation Executive, PD Manager, PD DGM,QA
Signature & Date
Page 1 of 1
 PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.
Rupshi,Narayanganj,Bangladesh
LIST OF STANDARD OPERATING PROCEDURE (SOP)

SL. Title Document No. Rev. Effective

No. No. Date

SOP FOR MAINTENANCE (PHARMA)

1.0 BREAKDOWN MAINTENANCE PROCEDURE SOP/NP/ENG/002 03 19 Dec.2015

Prepared by : Checked by : Approved by :

Name Nargis Sultana Ayesha Zaman Deb Narayan Biswas
Designation Executive, PD Manager, PD DGM,QA
Signature & Date
Page 1 of 1
 PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.
Rupshi,Narayanganj,Bangladesh
LIST OF STANDARD OPERATING PROCEDURE (SOP)

2.0 PLANNED MODIFICATION PROCEDURE SOP/NP/ENG/007 01 19 Dec.2015

3.0 PROCEDURE FOR CALIBRATION OF CRITICAL INSTRUMENT THAT SOP/NP/ENG/011 01 07 Aug.2017
ARE CALIBRATED FROM EXTERNAL AGENCIES
4.0 M0NSOON SAFETY PROCEDURE SOP/NP/ENG/018 00 08 Mar 2015
5.0 GENERAL MAINTENANCE WORK SOP/NP/ENG/021 01 19 Dec 2015
6.0 CLEANING OF OVERHEAD WATER TANKS SOP/NP/ENG/026 00 20 Jan 2015
7.0 SAFETY PROCEDURE SOP/NP/ENG/027 00 20 Jan 2015
8.0 SAFETY TRAINING OF FIRE EXTINGUISHER SOP/NP/ENG/028 00 08 Mar 2015
SOP FOR MAINTENANCE (HEALTHCARE)
1.0 PREVENTIVE MAINTENANCE PROCEDURE SOP/NP/ENG/001 03 21 Sep 2014
2.0 BREAKDOWN MAINTENANCE PROCEDURE SOP/NHCL/ENG./002 02 21 Sep 2014

3.0 OPERATION OF WATER PLANT FOR INJECTION SOP/NHCL/ENG./004 01 03 Dec 2014

4.0 PLANNED MODIFICATION PROCEDURE SOP/NHCL/ENG./009 01 19 Oct 2015
5.0 PASSIVATION & SANITATION PROCEDURE OF PURIFIED WATER SOP/NHCL/ENG./010 00 03 Dec 2014
SYSTEM
6.0 MONSOON SAFETY PROCEDURE SOP/NHCL/ENG./017 00 29 Nov 2014
7.0 GENERAL MAINTENANCE WORK SOP/NHCL/ENG./020 00 02 Dec 2014
8.0 CLEANING OF OVERHEAD WATER TANKS SOP/NHCL/ENG./025 00 23 Dec 2014

SL. Title Document No. Rev. Effective

No. No. Date

SOP FOR QC
1.0 CODING SYSTEM IN PRINTED PACKING MATERIAL SOP/NHCL/QC/016 00 02 MAY 2016
2.0 CODING SYSTEM IN PRINTED PACKING MATERIAL SOP/NP/QC/079 00 13 April 2016
3.0 PREPARATION,APPROVAL AND MANAGEMENT OF ARTWORKS SOP/NP/QC/082 00 04 Dec.2016
SOP FOR MICROBIOLOGY

Prepared by : Checked by : Approved by :

Name Nargis Sultana Ayesha Zaman Deb Narayan Biswas
Designation Executive, PD Manager, PD DGM,QA
Signature & Date
Page 1 of 1
 PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.
Rupshi,Narayanganj,Bangladesh
LIST OF STANDARD OPERATING PROCEDURE (SOP)

1.0 MICROBIAL LIMIT TEST OF RAW MATERIAL AND FINISHED SOP/NP/MB/005 01 27 April 2015
PRODUCT
2.0 ANTIMICROBIAL EFFECTIVENESS TEST SOP/NP/MB/035 00 23 Nov.2016

SL. Title Document No. Rev. Effective

No. No. Date

SOP FOR WAREHOUSE

1.0 ENTRY AND EXIT PROCEDURE FOR DISPENSING SOP/NP/WH/016 01 18 June 2017

Prepared by : Checked by : Approved by :

Name Nargis Sultana Ayesha Zaman Deb Narayan Biswas
Designation Executive, PD Manager, PD DGM,QA
Signature & Date
Page 1 of 1
 PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.
Rupshi,Narayanganj,Bangladesh
LIST OF STANDARD OPERATING PROCEDURE (SOP)

Prepared by : Checked by : Approved by :

Name Nargis Sultana Ayesha Zaman Deb Narayan Biswas
Designation Executive, PD Manager, PD DGM,QA
Signature & Date
Page 1 of 1