Devi management


(YOGESH NARKHEDE) #61

<a class="attachment" href="/uploads/default/original/2X/3/3497d7c7a48ff9d99af5258c3c83beb335a10d7b.pdf">I-PR-18-001.pdf</a> (4.9 MB)


(YOGESH NARKHEDE) #62

Feno Caps. USP 134 mg _ A1261503 ( 100 HDPE ) Stability Summary Report.pdf (2.6 MB)Feno Caps. USP 134 mg _ A1261504 ( 500 HDPE ) Stability Summary Report.pdf (2.6 MB)Feno Caps. USP 200 mg _ A1271501 ( 100 HDPE ) Stability Summary Report.pdf (2.7 MB)Feno Caps. USP 200 mg _ A1271501 ( 500 HDPE ) Stability Summary Report.pdf (2.6 MB)Feno Caps. USP 200 mg _ A1271502 ( 100 HDPE ) Stability Summary Report.pdf (2.6 MB)Feno Caps. USP 200 mg _ A1271502 ( 500 HDPE ) Stability Summary Report.pdf (2.6 MB)Feno Caps. USP 200 mg _ A1271503 ( 100 HDPE ) Stability Summary Report.pdf (2.6 MB)Feno Caps. USP 200 mg _ A1271503 ( 500 HDPE ) Stability Summary Report.pdf (2.6 MB)Feno Caps. USP 200 mg _ A1271504 ( 100 HDPE ) Stability Summary Report.pdf (2.7 MB)Feno Caps. USP 200 mg _ A1271504 ( 500 HDPE ) Stability Summary Report.pdf (2.5 MB)AQL.pdf (1.9 MB)
AQL;-2.pdf (1.6 MB)INSPECTION REPORT.pdf (2.8 MB)m3-2-s-3-1-elucidation-of-structure-and-other-characteristics.pdf (3.5 MB)


(YOGESH NARKHEDE) #63

MSDS.pdf (2.4 MB)
TSE BSE.pdf (89.4 KB)
031-13-001 (100’s count).doc (41.5 KB)
031-13-001 (100’s count).pdf (607.2 KB)
031-13-001 (500’s count).doc (41.5 KB)
031-13-001 (500’s count).pdf (578.5 KB)
031-13-002 (100’s count).doc (41.5 KB)
031-13-002 (100’s count).pdf (554.0 KB)031-13-002 (500’s count).doc (41.5 KB)
031-13-002 (500’s count).pdf (563.8 KB)
031-13-003 (100’s count).doc (41.5 KB)
031-13-003 (100’s count).pdf (500.3 KB)
031-13-003 (500’s count).doc (41.5 KB)
031-13-003 (500’s count).pdf (544.7 KB)031-13-001 (100,s Pack) - 2.PDF (1.3 MB)
031-13-001 (100,s Pack) - 3.PDF (1.1 MB)
031-13-001 (500,s Pack) - 1.PDF (1.3 MB)
031-13-001 (500,s Pack) - 5.PDF (1.1 MB)031-13-002 (100,s Pack) - 4.PDF (1.3 MB)
031-13-002 (100,s Pack) - 6.PDF (1.1 MB)
031-13-002 (500,s Pack) - 7.PDF (1.3 MB)
031-13-002 (500,s Pack) - 8.PDF (1.1 MB)031-13-003 (100,s Pack) - 9.PDF (1.1 MB)
031-13-003 (100,s Pack) - 11.PDF (1.3 MB)
031-13-003 (500,s Pack) - 10.PDF (1.1 MB)
031-13-003 (500,s Pack) - 12.PDF (1.4 MB)Met. US SP. C-STBP-013-001.pdf (2.6 MB)
Met. US SP. C-STBP-013-002.pdf (1.8 MB)Metformin HCL ER Tablets USP 500mg_031_13_004_9M_100’sHDPE_2560.pdf (1.3 MB)
Metformin HCL ER Tablets USP 500mg_031_13_004_9M_500’sHDPE_2560.pdf (1.3 MB)
Metformin HCL ER Tablets USP 500mg_031_13_005_9M_100’sHDPE_2560.pdf (1.3 MB)Metformin HCL ER Tablets USP 500mg_031_13_005_9M_500’sHDPE_2560.pdf (1.3 MB)
Metformin HCL ER Tablets USP 500mg_031_13_006_9M_100’sHDPE_2560.pdf (1.3 MB)
Metformin HCL ER Tablets USP 500mg_031_13_006_9M_500’sHDPE_2560.pdf (1.3 MB)VP_HT_15.pdf (1.2 MB)
VP_HT_15A.pdf (1.1 MB)
VP_HT_16.pdf (1.1 MB)
VP_HT_16A.pdf (970.4 KB)VR_HT_15.pdf (1.2 MB)
VR_HT_16.pdf (1.2 MB)Metformin us batch PV protocol.pdf (4.5 MB)Addendum to PV protocol.PDF (2.5 MB)SAN16001.pdf (163.0 KB)
SAN16002.pdf (162.2 KB)
SAN16003.pdf (160.1 KB)
COC - SAN18023.pdf (325.1 KB)
SAN18023.doc (48 KB)Feno Caps. USP 134 mg _ A1261501 ( 500 HDPE ) Stability Summary Report.pdf (2.7 MB)


(YOGESH NARKHEDE) #64

1. Telmisartan Granules 1212.docx (258.2 KB)
CPV Report common blend for Telmisartan tablet 20mg, 40mg and 80mg.docx (119.6 KB)
CQA Data 2018.xlsx (469.2 KB)
CPV Report for Metformine HCL ER Tablets USP 500 mg.docx (253.7 KB)
CPP Data 2018 10mg.xlsx (56.9 KB)
CQA Data 2018 10mg.xlsx (73.8 KB)
CPP Data 2018 15mg.xlsx (55.7 KB)
CQA Data 2018 15mg.xlsx (73.3 KB)
CPP Data 2018 30mg.xlsx (55.0 KB)
CQA Data 2018 30mg.xlsx (72.0 KB)
API CQA Data 2018.xlsx (30.8 KB)
<a class=“attachment” href="/uploads/default/original/2X/2/27c90ceec5a81f6cCQA Data 2016.xlsx (62.5 KB)
CQA Data 2017.xlsx (66.2 KB)
CQA Data 2018.xlsx (59.7 KB)
CPP Data 2018 60mg.xlsx (33.8 KB)
CQA Data 2018 30mg.xlsx (86.0 KB)
98d88a5cc548fb5590591afa.xlsx">CPP Data 2018.xlsx (22.4 KB)
CQA. Data 2018.xlsx (22.8 KB)
CPP Data 2018 7.5mg.xlsx (55.5 KB)
CQA Data 2018 7.5mg.xlsx (71.9 KB)

CPP Data 2018 5mg.xlsx (56.7 KB)
CQA Data 2018 5mg.xlsx (74.0 KB)CPP Data 2018 60mg.xlsx (33.8 KB)
CQA Data 2018 60mg.xlsx (85.3 KB)
API CQA Data 2018.xlsx (31.5 KB)
CPP Data 2018.xlsx (49.7 KB)
CQA. Data 2018.xlsx (37.2 KB)
CPV Report Duloxetine DR Capsule 60mg USP.docx (113.6 KB)
Duloxetine DR Capsules file.xlsx (19.4 KB)
CPP Data 2018 20mg.xlsx (31.2 KB)
CPV Data 2016-2018.xlsx (86.8 KB)
CPP Data 2018 30mg.xlsx (33.2 KB)
CQA Data 2016 30mg.xlsx (85.2 KB)
CQA Data 2018 30mg.xlsx (97.7 KB)
CPP Data 2018 30mg.xlsx (33.2 KB)
CPP Data 2018 60mg.xlsx (33.9 KB)
CQA Data 2016 60mg.xlsx (85.8 KB)
CQA Data 2018 60mg.xlsx (98.3 KB)API CQA Data 2018.xlsx (44.8 KB)
<a class=“attachment” href="/uploads/default/original/2X/3/3c0f4cc31ea623527b7426CPP Data 67mg.xlsx (32.1 KB)
CQA Data 67mg.xlsx (68.4 KB)
CPP Data 134mg.xlsx (32.2 KB)
CQA Data 134mg.xlsx (68.2 KB)
CPP Data 200mg.xlsx (32.1 KB)
CQA Data 200 mg.xlsx (68.4 KB)
API CQA Data 2017.xlsx (36.0 KB)
CPP Data 2017.xlsx (32.4 KB)
CQA Data for 67, 134 & 200 mg.xlsx (23.5 KB)
3f7719a0127743be54.xlsx">CPP Data 2018.xlsx (49.5 KB)
CQA Data 2016 & 2018.xlsx (36.0 KB)1 Metformin HCl ER Tablets USP 500mg Limit report.docx (722.2 KB)
Met CQAs file.xlsx (63.3 KB)
Metformin HCl ER Tablets USP 500mg Limit report.docx (727.1 KB)
CQA Data 2018.xlsx (167.2 KB)
CQA Data 2018.xlsx (469.5 KB)
CPP Data 2018 form B. NO- 03118376.xlsx (632.8 KB)
CPV Report for Metformine HCL ER Tablets USP 500 mg.docx (359.4 KB)CQA Data 2018.xlsx (167.2 KB)
CPP Data 2018 form B. NO- 03118283.xlsx (670.8 KB)CQA Data 2018.xlsx (167.2 KB)
CPP Data 2018 form B. NO- 03118376.xlsx (632.4 KB)
CQA Data 2018.xlsx (469.5 KB)Common Blend for Telmisartan Tablets 20 mg 40 mg 80 mg Final copy.docx (211.2 KB)
Common Blend for Telmisartan Tablets 20 mg, 40 mg, 80 mg.docx (253.8 KB)
Telmisartan tablet USP 40 mg.docx (318.1 KB)
Telmisartan tablet USP 80 mg Final.docx (323.4 KB)CPP Data 2016.xlsx (37.8 KB)
CPP Data 2017.CQA Data 2016.xlsx (37.6 KB)
CQA Data 2017.xlsx (42.4 KB)
CQA Data 2016.xlsx (42.7 KB)
CQA Data 2017.xlsx (43.4 KB)
CQA Data 2018.xlsx (42.7 KB)
CQA Data 2018.xlsx (39.1 KB)
Telmi Blend CQAs file.xlsx (10.7 KB)
xlsx (41.4 KB)
CPP Data 2018 -.xlsx (39.3 KB)
Telmi Blend CPPs (1).xlsx (19.6 KB)1. Telmi 80 CPPs.xlsx (24.4 KB)
CPV Report Telmisartan tablet 20mg US.docx (116.2 KB)
CPV Report Telmisartan tablet 40mg US.docx (115.4 KB)
CPV Report Telmisartan tablet 80mg US.docx (123.9 KB)
Telmi 20 CQAs CPPs file…xlsx (22.0 KB)
Telmi 80 CQAs.xlsx (16.0 KB)
Telmisartan tablet USP 20 mg.docx (484.6 KB)
CPP Data 2016-17-18 20mg.xlsx (58.6 KB)
CPP Data 2016-17-18 40mg.xlsx (64.7 KB)
CPP Data 2016 80mg.xlsx (58.0 KB)
CPP Data 2017-18 80mg.xlsx (70.4 KB)CQA Data 2016-2017-18 20mg.xlsx (57.9 KB)
CQA Data 2016-2017-18 40mg.xlsx (62.8 KB)
CQA Data 2016 80mg.xlsx (58.1 KB)
CQA Data 2017-18 80mg.xlsx (78.9 KB)CPV Report Duloxetine DR Capsule 60mg USP.docx (113.6 KB)
Duloxetine DR Capsules file.xlsx (19.4 KB)CPP Data 2018 20mg.xlsx (31.2 KB)
CPV Data 2016-2018.xlsx (86.8 KB)
CPP Data 2018 30mg.xlsx (33.2 KB)
CPP Data 2018 30mg.xlsx (33.2 KB)
CQA Data 2016 30mg.xlsx (85.2 KB)
CQA Data 2018 30mg.xlsx (97.7 KB)
CPP Data 2018 60mg.xlsx (33.9 KB)
CQA Data 2016 60mg.xlsx (85.8 KB)
CQA Data 2018 60mg.xlsx (98.3 KB)
API CQA Data 2011. Telmisartan Granules report.docx (360.0 KB)
Annexure I.pdf (67.0 KB)
Annexure II.pdf (149.2 KB)
CCP…xlsx (307.4 KB)
duloxetine 3 sigma.xlsx (75.0 KB)
Duloxetine Date Wise details.xlsx (9.9 KB)
DULOXETINE DR CAPS USP 20-30 AND 60 MG…xlsx (20.0 KB)
Met Drying temp.xlsx (10.8 KB)
Traning Record Abhijit Patil.pdf (947.6 KB)
US Products List.xlsx (9.7 KB)
wms 2016.xlsx (1.3 MB)
8.xlsx (44.8 KB)
CPP Data 2018.xlsx (49.5 KB)
CQA Data 2016 & 2018.xlsx (36.0 KB)CPV Annexure I.docx (65.6 KB)
CPV Annexure II.docx (60.8 KB)
CPV SOP CM…pdf (338.1 KB)
CPV SOP CM.pdf (338.2 KB)
Draft SOP for CPV.docx (53.8 KB)


(YOGESH NARKHEDE) #65

apr 2018.pdf (66.0 KB)
aug 2017.pdf (67.0 KB)
aug 2018.pdf (66.2 KB)
ctc 2018.pdf (64.3 KB)
dec 2017.pdf (67.6 KB)
dec 2018.pdf (66.3 KB)
feb 2018.pdf (65.7 KB)
jan 2018.pdf (65.7 KB)
jul 2017.pdf (65.7 KB)
jul 2018.pdf (66.2 KB)
jun 2017.pdf (66.3 KB)
jun 2018.pdf (66.6 KB)
mar 2018.pdf (66.2 KB)
may 2017.pdf (66.7 KB)
may 2018.pdf (67.3 KB)
nov 2017.pdf (66.0 KB)
Uploading: nov 2018.pdf… oct 2018.pdf (66.5 KB)
sep 2017.pdf (65.8 KB)
Uploading: sep 2018.pdf…

canada and turkey registration.pdf (730.6 KB)
south africa registration.pdf (683.8 KB)
SUPAC Guidlines.pdf (59.9 KB)
US and EU.pdf (857.1 KB)
anda checklist december 2011 ucm151259.pdf (84.4 KB)
ANDA CHECKLIST.pdf (1.1 MB)ASEAN-Variation-Guideline-for-Pharmaceutical-Products_Final-Adopted-Document.pdf (274.3 KB)7883441_DataIntegrity.pdf (127.1 KB)
CGMP.pdf (362.9 KB)GDP SOP.docx (99.4 KB)


(YOGESH NARKHEDE) #66

ADDENUM TO PERFORMANCE QUALIFICATION REPORT.pdf (384.2 KB)
ATTACHMENT_I.pdf (427.5 KB)
IQP.pdf (2.5 MB)
OQP.pdf (896.0 KB)

DATA SHEET.pdf (1.9 MB)
DQP.pdf (1.8 MB)DQR.pdf (2.2 MB)IQP.pdf (1.7 MB)
IQR.pdf (2.1 MB)OQP.pdf (1.6 MB)
OQR.pdf (2.1 MB)TRAINING REPORT.pdf (383.0 KB)
DQP 850KG.pdf (2.4 MB)DQR 850KG.pdf (2.5 MB)IQP 850KG.pdf (2.7 MB)IQR 850KG.pdf (2.5 MB)OQP 850KG.pdf (2.1 MB)
OQR 850KG.pdf (2.4 MB)PARCHASE ORDER 850KG.pdf (3.5 MB)
QD 850KG.pdf (253.9 KB)
TRAINIG REPORT 850KG.pdf (380.4 KB)DQP.pdf (2.4 MB)
IQP.pdf (2.4 MB)OQP.pdf (1.8 MB)
PQP.pdf (1.7 MB)DQR.pdf (2.5 MB)IQR.pdf (2.5 MB)OQR.pdf (2.1 MB)PQR.pdf (2.5 MB)PURCHASE ORDER.pdf (2.5 MB)ROUTINE TEST CERTIFICATE.pdf (2.6 MB)CERTIFICATE.pdf (3.4 MB)AVT.pdf (3.3 MB)AVT.pdf (500.0 KB)
IQP.pdf (3.7 MB)OQP.pdf (2.1 MB)
OQR.pdf (2.7 MB)PCT.pdf (2.0 MB)
PHLIT.pdf (1.7 MB)PQP.pdf (1.9 MB)PQR.pdf (4.2 MB)IQR.pdf (3.9 MB)OQR.pdf (1.7 MB)
PQP.pdf (775.4 KB)
PQR_PHASE-1.pdf (887.3 KB)
PQR_PHASE-II.pdf (856.3 KB)
PURCHASE ORDER.pdf (981.7 KB)
PURIFIED WATER SYSTEM.pdf (286.2 KB)PQR_PHASE-III.pdf (3.7 MB)
REVALIDATION SUMMARY OF WATER SYSTEM_2009-2010.pdf (241.4 KB)
REVALIDATION SUMMARY OF WATER SYSTEM_2010-2011.pdf (472.4 KB)REVALIDATION SUMMARY OF WATER SYSTEM_2009-2010.pdf (241.4 KB)
REVALIDATION SUMMARY OF WATER SYSTEM_2011-2012.pdf (472.8 KB)
USER REQUIREMENT SPECIFICATION.pdf (1.7 MB)AQR 08.pdf (4.3 MB)AQR 09.pdf (2.2 MB)
AQR 10.pdf (2.1 MB)AQR 11.pdf (2.6 MB)
AQR 12.pdf (2.4 MB)AQR 13.pdf (2.3 MB)
AQR 14.pdf (2.5 MB)AQR 16.pdf (2.1 MB)
AQR 17.pdf (2.3 MB)AQR 18.pdf (2.1 MB)AQD.pdf (2.1 MB)
AQR TM-04.pdf (2.1 MB)AQR TM-01.pdf (3.2 MB)AQR TM-02.pdf (3.3 MB)AQR TM-03.pdf (3.2 MB)


(YOGESH NARKHEDE) #67

CCP.RE.006.16.pdf (1.2 MB)
CCP.RE.008.16.pdf (1.1 MB)
CCP.RE.011.16.pdf (1.0 MB)CCP.RE.005.16.pdf (2.7 MB)
CCP.RE.016.16.pdf (951.6 KB)
CCP.RE.021.16.pdf (1.6 MB)CCP.RE.009.16.pdf (2.9 MB)CCP.RE.012.16.pdf (2.9 MB)CCP.RE.013.16.pdf (3.8 MB)CCP.RE.018.16.pdf (5.0 MB)CCP.RE.020.16.pdf (4.6 MB)CCP.RE.021.16.pdf (1.6 MB)
CCP.RE.022.16.pdf (995.2 KB)Addendum Panfor Vietnam - Revised CCP RE 023 16.pdf (1.5 MB)
CCP.RE.024.16.pdf (772.3 KB)
Fenofibrate requirement for new FPS & MOA.pdf (94.3 KB)
Mail - [email protected] (460.0 KB)
Pregabalin requiremnet for new FPS.MOA.pdf (88.4 KB)
Receipt of approval - Levo MD 5 - Srilanka.pdf (115.7 KB)
Receipt of approval Redlip - Reliv vietnam.pdf (75.6 KB)
Sildenafil requirement for new FPS & MOA.pdf (99.5 KB)
Specifiaction published details.pdf (74.2 KB)


(YOGESH NARKHEDE) #68

CCP.RE.002.16.pdf (2.1 MB)
CCP.RE.005.16.pdf (2.7 MB)

C.RE.18.006.pdf (4.6 MB)C.RE.18.017.pdf (3.2 MB)C.RE.18.018.pdf (2.5 MB)
C.RE.18.028.pdf (2.1 MB)C.RE.18.025.pdf (2.7 MB)
C.RE.18.035.pdf (1.9 MB)C.RE.18.027.pdf (4.1 MB)C.RE.18.031.pdf (4.7 MB)C.RE.18.039.pdf (2.0 MB)
C.RE.18.040.pdf (2.2 MB)C.RE.18.058.pdf (4.3 MB)C.RE.18.053.pdf (4.7 MB)C.RE.18.041.pdf (2.7 MB)
C.RE.18.042.pdf (824.7 KB)
C.RE.18.046.pdf (1.5 MB)C.AD.18.003.pdf (3.8 MB)C.RE.18.003.pdf (2.9 MB)
Specification & ADS details.pdf (964.7 KB)C.RE.18.004.pdf (1.9 MB)
Specification details.pdf (655.7 KB)Addendum A1 C.RE.18.009 Darifenacin.pdf (1.5 MB)
C.RE.18.009.pdf (1.0 MB)
Dari spec compilation.xls (36 KB)
Specification and ADS details.pdf (967.6 KB)C.RE.18.010.pdf (2.6 MB)
Draft Submission - A1.pdf (779.3 KB)
FPS0090-AC-1 Draft FPS.docx (53.1 KB)Addendum A1 C RE 18 010 -Glimmetfortabs.pdf (4.5 MB)C.RE.18.013.pdf (1.5 MB)
C.RE.18.015.pdf (956.4 KB)
C.RE.18.016.pdf (927.1 KB)
IPS Specification details of A1 - C.RE.18.016.pdf (73.3 KB)C.RE.18.017.pdf (3.2 MB)
Specification details.pdf (798.1 KB)
Tracker.pdf (193.1 KB)Addendum A1 C RE 18 019 Tolterodine Tratrate 2 4 mg US Market.pdf (385.1 KB)
Addendum A2 to C.RE.018.19_Tol Tartrate Uquifa.pdf (531.7 KB)
Addendum A3 C.RE.18.019.pdf (688.6 KB)
C.RE.18.019.pdf (1.3 MB)
C.RE.18.020.pdf (2.2 MB)
C-RE-18-020 Schedule notification.xlsx (10.9 KB)
Rule 96 and 97 implementation status all sites - Alkem.xlsx (9.2 KB)<a class="attachment" href="/uploads/default/original/2X/c/cb5bb17534aa1205aa6d2687ea7104ce07bb241e.pdf">C.RE.18.021.pdf</a> (2.5 MB) <a class="attachment" href="/uploads/default/original/2X/9/9cce87c3fb4f7ce5a3dd7f2ab05eca6b46bd0067.pdf">ROS Comparasion (RPL Vs RDPL).pdf</a> (1.6 MB) <a class="attachment" href="/uploads/default/original/2X/f/f319d10d2fd6c4e6880afff6014561e101bc349d.pdf">Sildenafil USP.pdf</a> (116.2 KB)C.RE.18.021.pdf (2.5 MB)
ROS Comparasion (RPL Vs RDPL).pdf (1.6 MB)
Sildenafil USP.pdf (116.2 KB)C.RE.18.025.pdf (2.7 MB)
SOP details.pdf (1002.6 KB)
Specification details.pdf (791.9 KB)
Tracker.pdf (192.2 KB)Addendum A1 C.RE.18.029.pdf (2.8 MB)
FPS and ADS details.pdf (1.0 MB)C.RE.18.030.pdf (1.2 MB)
Int BMR details.pdf (1.7 MB)
Specs and ADS details.pdf (1013.4 KB)C.RE.18.031.pdf (4.7 MB)Client intimation.pdf (781.5 KB)
Specification details.pdf (1.6 MB)
Tracker.pdf (188.6 KB)C.RE.18.032.pdf (2.1 MB)
Declaration letter (DRL).pdf (213.7 KB)
AVL updation details.pdf (1.1 MB)
C.RE.18.033.pdf (1.5 MB)Addendum A1 C RE 18 033 for Rosuvastatin_.pdf (537.4 KB)
API specs details.pdf (859.2 KB)
FPS IPS details.pdf (862.8 KB)
MMD details.pdf (800.2 KB)
FPS IPS details.pdf (801.0 KB)
Int BMR details.pdf (1.6 MB)
RM and Excipients details.pdf (1.0 MB)API specification and ADS details.pdf (1.0 MB)
Excipients specification and ADS details.pdf (1023.2 KB)
FP specification and ADS details.pdf (1.0 MB)
BMR details.pdf (429.2 KB)
C.RE.18.038.pdf (798.7 KB)
Client Intimation.pdf (778.4 KB)C.RE.18.043 A1 Felodipine MLT addition.pdf (1.2 MB)
C.RE.18.043.pdf (887.4 KB)
General testing specs and MOA details.pdf (790.5 KB)
Specification and ADS details.pdf (1.0 MB)C.RE.18.045.pdf (2.0 MB)
Copy of Copy of Olmesartan quries.xlsx (10.3 KB)
Sampling protocol1.pdf (297.2 KB)
C.RE.18.047.pdf (900.3 KB)
Capsule colour Approval.pdf (1.1 MB)IPS details.pdf (793.3 KB)
PD response.pdf (1.5 MB)
Specification related changes.xlsx (9.7 KB)
Venla Intended BMR communication.pdf (1.1 MB)C.RE.18.050.pdf (1.0 MB)
Client Intimation.pdf (788.4 KB)
Specification details.pdf (797.5 KB)
C.RE.18.051.pdf (1.5 MB)
Rabeprazole Na - MOA - Comaprison - IH -DMF.docx (40.5 KB)
Rabeprazole Sodium IH - USP.xls (39 KB)API specs and ADS details.pdf (1.0 MB)
ARD communication.pdf (1.0 MB)
C.RE.18.055.pdf (1013.4 KB)ADS details.pdf (1.0 MB)
C.RE.18.056.pdf (1011.9 KB)
Specification details.pdf (795.9 KB)
MLT communication.pdf (1021.4 KB)
MLT list and SAP updation details.pdf (1.3 MB)
Specification details 500mg.pdf (598.8 KB)
Specs details.pdf (602.9 KB)
Tracker.pdf (190.3 KB)C.RE.18.058.pdf (4.3 MB)C.RE.18.059.pdf (3.0 MB)
Client Intimation.pdf (788.4 KB)
Specs and ADS details.pdf (1.0 MB)Tracker.pdf (191.5 KB)
BPR details.pdf (212.1 KB)
C.RE.18.060.pdf (2.3 MB)Copy of Copy of Nitrofurantoin CRL FDA_.xls (35 KB)
Copy of Nitrofurantoin CRL FDA .xls (35 KB)
ADS details.pdf (1.0 MB)
C.RE.18.067.pdf (770.3 KB)
FPS and IPS details.pdf (797.4 KB)C.RE.18.069.pdf (3.2 MB)
Code list details.pdf (1.4 MB)BMR and BPR details.pdf (437.1 KB)
Client intimation.pdf (822.4 KB)
Specs details - 1.pdf (731.6 KB)
Specs details - 2.pdf (519.7 KB)
C.RE.18.071.pdf (2.2 MB)
Specification and ADS details.pdf (1.0 MB)Barole 20 Cap_Revalidated CPR.pdf (1.5 MB)Barole 20_Batch Formula.pdf (159.0 KB)
CCP for paliperidone.pdf (242.8 KB)
Changes to be implemented for Dapagliflozin Tablets 5 and 10 mg as per DRL.docx (21.1 KB)
Chlorthalidone queries 5.04.18.xlsx (14.4 KB)
Clent mail communication.pdf (438.2 KB)
Client & RA revert.pdf (94.1 KB)
Comparison of Impurities in Tolterodine_UQUIFA_USP.DOC (113.5 KB)
Copy of Copy of Copy of Queries Nitrofurantoin (002) new.xls (41.5 KB)
Copy of Copy of Copy of Rosuvastatin.xlsx (9.3 KB)
Copy of Copy of Rosuvastatin.xlsx (9.3 KB)
Copy of Rosuvastatin queries.xlsx (9.0 KB)
existing formula of EM. Eg; Panfor _ Proglutrol 500.pdf (46.0 KB)
Fornid XR - Mail.pdf (434.0 KB)
Glimepiride correspondence.pdf (52.3 KB)
Intimation mail (2).pdf (158.8 KB)
Intimation mail.pdf (185.6 KB)
Nitrofurantoin - Dissolution limits.docx (22.0 KB)
Olmesartan quries.xlsx (10.2 KB)
Queries Nitrofurantoin annexure.xls (42 KB)
Chlorthalidone queries 5.04.18.xlsx (14.4 KB)
Tolterodine - Draft MOA.docx (54.1 KB)
Tolterodine - Draft spec.docx (47.1 KB)
TOLTERODINE TARTRATE DECLARATION.pdf (394.3 KB)
Ukrain & Kenya BMR list.pdf (85.8 KB)C.RE.17.002.pdf (1.5 MB)
C.RE.17.006.pdf (969.1 KB)
C.RE.17.007.pdf (924.2 KB)C.RE.17.003.pdf (4.0 MB)C.RE.17.009.pdf (1.1 MB)
C.RE.17.010.pdf (2.8 MB)C.RE.17.011.pdf (1.1 MB)
C.RE.17.014.pdf (2.4 MB)
CCP.RE.002.17.pdf (1.1 MB)C.RE.17.015.pdf (4.2 MB)CCP.RE.002.17.pdf (1.1 MB)
CCP.RE.003.17.pdf (2.6 MB)CCP.RE.004.17.pdf (4.2 MB)CCP.RE.005.17.pdf (3.4 MB)CCP.RE.006.17.pdf (2.5 MB)CCP.RE.007.17.pdf (3.1 MB)CCP.RE.011.17.pdf (894.5 KB)
CCP.RE.001.17.pdf (3.5 MB)Addendum for CCP No CCP-RE-001-17.pdf (763.2 KB)
Barole 10 - Approved Formula.pdf (104.7 KB)
Barole 20 - Approved Formula.pdf (55.3 KB)
Colestrim - Approved Formula.pdf (60.1 KB)
Limzer - Approved Formula.pdf (106.5 KB)
Mega Products Renewal- Variation Approval Status - Copy.xlsx (16.9 KB)
Nilgar M 15 - Approved Formula.pdf (85.4 KB)
Nilgar M 30 - Approved Formula.pdf (88.4 KB)
No change in Myanmar for Panfor SR 1000 confirmation from Regulatory.pdf (114.7 KB)
Panfor SR - 500- Approved Formula.pdf (11.8 KB)
Panfor SR - 1000- Approved Formula.pdf (58.3 KB)
Perglim 1 - Approved Formula.pdf (65.0 KB)
Perglim 2 - Approved Formula.pdf (62.6 KB)
Perglim M 1 - Approved Formula.pdf (85.1 KB)
Perglim M2 -Approved Formula.pdf (118.7 KB)
CCP.RE.007.17.pdf (3.0 MB)Intimation mail.pdf (1.4 MB)
Specification details.pdf (1.0 MB)
Addendum for CCP No CCP-RE-009-17.pdf (496.1 KB)
BPR obsoletion details.pdf (1.6 MB)
PM specification made obsolete.pdf (85.5 KB)
Specification details.pdf (109.7 KB)
Tracking.pdf (198.0 KB)DN-PM-17-0050 COLESTRIM PACKING MATERIEL-Destruction report.pdf (3.1 MB)
Intimation mail.pdf (1.6 MB)C.RE.17.013.pdf (1.2 MB)
Client method.pdf (100.8 KB)
For CM Comparision & compilation for C-RE-17-016-Perglim M1.xlsx (34.2 KB)
For CM C-RE-17-016 Comparision & compilation for Perglim M2.xlsx (29.4 KB)
FPS0028-A- MOA -Draft-.docx (60.6 KB)
FPS0028-A-FPS draft.docx (49.3 KB)
Intimation mail.pdf (188.8 KB)
Mail.ref.pdf (790.1 KB)
Pregablin Ph Eur.pdf (249.4 KB)CCP approval status in days.xlsx (372.3 KB)
CCP Quality Tracker 2016.xlsx (2.2 MB)
CCP status 10 Nov 2017.xlsx (12.0 KB)
CCP status 2016.xls (87 KB)
CQ spec updates.xlsx (8.7 KB)
List of CMC documents.xls (30.5 KB)
Mkg pending CCP.xlsx (10.6 KB)
Tracking for Hold time data.xlsx (11.1 KB)CCP.RE.001.16.pdf (3.1 MB)
CCP.RE.004.16.pdf (1.7 MB)


(YOGESH NARKHEDE) #69

D.PU.18.012.pdf (4.2 MB)
D-BD-18-013.pdf (1.5 MB)

D-PR-18-001.pdf (345.2 KB)
D-PR-18-002.pdf (2.3 MB)D-PR-18-008.pdf (4.5 MB)
Quality tracker 2018.pdf (13.3 KB)D-PR-18-009.pdf (2.4 MB)
Quality tracker 2018.pdf (76.8 KB)Addendum A1 to D-PR-18-010.pdf (333.3 KB)
D-PR-18-010.pdf (4.1 MB)D-PR-18-011.pdf (2.6 MB)D-PR-18-012.pdf (2.0 MB)D-PR-18-015.pdf (1.3 MB)
Quality tracker 2018.pdf (10.2 KB)
D-PR-18-016 For Closing.pdf (590.6 KB)
D-PR-18-016c.pdf (618.2 KB)D-PR-18-017.pdf (2.5 MB)D-PR-18-018.pdf (1.8 MB)D-BD-18-003.pdf (2.7 MB)D.BD.18.016.A1.pdf (888.3 KB)
D-BD-18-016.pdf (1.6 MB)D-BD-18-002.pdf (951.1 KB)
D-BD-18-007.pdf (635.8 KB)D-BD-18-011.pdf (2.7 MB)D-BD-18-012.pdf (842.1 KB)D-BD-18-014.pdf (1.9 MB)D-BD-18-017.pdf (748.1 KB)
D-BD-18-018.pdf (1.5 MB)
D-BD-18-019.pdf (4.3 MB)D-BD-18-020.pdf (3.5 MB)D-BD-18-022.pdf (1.2 MB)
D-BD-18-025.pdf (1.5 MB)D-BD-18-026.pdf (3.5 MB)D-BD-18-029.pdf (730.1 KB)D-BD-18-032.pdf (2.4 MB)D-BD-18-034.pdf (895.1 KB)D-BD-18-037.pdf (2.4 MB)D-BD-18-001.pdf (612.6 KB)D-BD-18-006.pdf (2.8 MB)
D-BD-18-008.pdf (800.4 KB)D-BD-18-010.pdf (2.0 MB)
D-BD-18-023.pdf (582.4 KB)D.PU.18.007.A1.pdf (637.1 KB)
D-PU-18-007.pdf (1.7 MB)
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D.PU.18.006.pdf (822.3 KB)D.PU.18.012.pdf (4.2 MB)D.PU.18.013.pdf (1.5 MB)
D-PU-18-013 Sharad and Sons Vendor CAPA.pdf (414.6 KB)D.PU.18.014.pdf (849.0 KB)
D-PU-18-021.pdf (2.1 MB)
D.PU.18.016.pdf (757.8 KB)
D-PU-18-027.pdf (1.6 MB)Quality Tracker 18 Corporate Deviation.xls (1.6 MB)
D-BD-18-009.pdf (719.3 KB)
D-BD-18-035.pdf (911.0 KB)
D-BD-18-036.pdf (3.4 MB)
D-BD-18-038.pdf (763.0 KB)
D-BD-18-039.pdf (824.1 KB)
Ganaton Total-FLQR.pdf (913.4 KB)
Myotop ZPD4AC8005.pdf (361.8 KB)D.BD.18.004.A1.pdf (371.3 KB)
D-BD-18-004.pdf (848.5 KB)D-BD-18-015.pdf (873.7 KB)
D-BD-18-021.pdf (804.9 KB)
D-BD-18-021-A1.pdf (478.5 KB)BPR - label changing activity.pdf (264.0 KB)
BPR…pdf (283.5 KB)
D-BD-18-024.pdf (1.0 MB)
D-BD-18-024-A1.pdf (659.5 KB)D-BD-18-026.pdf (3.5 MB)D-BD-18-027.pdf (765.0 KB)
D-BD-18-028.pdf (565.4 KB)
D-BD-18-030.pdf (1.7 MB)D-BD-18-031.pdf (805.5 KB)D-BD-18-033.pdf (789.3 KB)D.CQ.18.003.pdf (1.6 MB)
D.CQ.18.002.pdf (879.1 KB)Uploading: D-FD-18-001.pdf… Uploading: D-FD-18-001-A1.pdf…D-FD-18-001.pdf (812.9 KB)
D-FD-18-001-A1.pdf (634.9 KB)D-PP-18-015.pdf (2.1 MB)D-PP-18-014…pdf (1.2 MB)
D-PP-18-014-A1.pdf (480.3 KB)D.PU.18.002.pdf (496.8 KB)
D.PU.18.017.pdf (694.0 KB)
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D.PU.18.005.pdf (570.1 KB)
Process change.pdf (360.4 KB)D.PU.18.008.pdf (637.5 KB)
Extension of TCD.pdf (1.1 MB)D.PU.18.009.A1.pdf (376.0 KB)
D.PU.18.009.A2.pdf (563.9 KB)
D.PU.18.009.pdf (3.6 MB)D.PU.18.011.pdf (574.2 KB)D.PU.18.015.pdf (769.0 KB)
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D-PU-18-015-A3.pdf (1.2 MB)D.PU.18.018.pdf (827.6 KB)
D-PU-18-018 CAPA 018-07-01.pdf (184.9 KB)
Glychiphage G2 forte vendor CAPA D-PU-18-018.pdf (851.1 KB)
D.PU.18.019.pdf (1.1 MB)D.PU.18.020.pdf (881.6 KB)D-PU-18-021.pdf (2.1 MB)D-PU-18-022.pdf (1.7 MB)D-PU-18-024.pdf (836.7 KB)
Vendor CAPA D-PU-18-024.pdf (583.0 KB)D-PU-18-025.pdf (4.9 MB)D-PU-18-026.pdf (916.3 KB)
D-PU-18-028.pdf (2.5 MB)
D-PU-18-028-A1.pdf (502.6 KB)D-PU-18-030.pdf (1.3 MB)D.RE.18.001.pdf (3.2 MB)
D-RE-18-004.pdf (1.3 MB)D.RE.18.002.pdf (4.9 MB)D.RE.18.003.pdf (966.1 KB)
D-RE-18-003 Rational for Applicability_Metformin Tabs.pdf (150.6 KB)


(YOGESH NARKHEDE) #70

Investigation Report I-PR-18-001.pdf (166.8 KB)
I-PR-18-001.pdf (4.9 MB)I-PR-18-004.pdf (1.5 MB)I-PR-18-005.pdf (2.5 MB)I-PR-18-006.pdf (2.9 MB)I-PR-18-008.pdf (4.3 MB)Investigation Report I-PR-18-010.pdf (429.0 KB)
I-PR-18-017.pdf (4.0 MB)I-PR-18-018…pdf (877.5 KB)I-PR-18-022.pdf (1.3 MB)Investigation Report I-PR-18-025.pdf (429.2 KB)
I-PR-18-025.pdf (2.8 MB)I-PR-18-028.pdf (1.7 MB)I-PR-18-034.pdf (1.0 MB)I-PR-18-035.pdf (1.9 MB)I-PR-18-037…pdf (1.2 MB)I-PR-18-040…pdf (880.5 KB)
InvestigationReport I-PR-18-041.pdf (286.0 KB)
I-PR-18-041…pdf (1.2 MB)I-PR-18-044…pdf (2.4 MB)
Panfor SR 500 b.no. PAF01419 Investigation Attachment.pdf (1.6 MB)I-PR-18-046.pdf (637.1 KB)
I-PR-18-052.pdf (886.4 KB)
I-PR-18-056…pdf (1.2 MB)I-PR-18-059.pdf (917.7 KB)
I-PR-18-072.pdf (1.9 MB)I-PR-18-127.pdf (624.0 KB)
I-PR-18-226.pdf (2.4 MB)I-QA-18-004.pdf (1.5 MB)
I-QA-18-009.pdf (2.9 MB)I-QA-18-033.pdf (4.8 MB)I-EN-18-002.pdf (906.8 KB)
Assessment Form EN037 EN174.pdf (416.5 KB)
I-EN-18-005.pdf (2.6 MB)
Micro data_2017_SP10 & SP13.pdf (111.0 KB)I-EN-18-006.pdf (2.6 MB)
Micro data Jan-Dec 2017.doc (152 KB)I-EN-18-007.pdf (4.2 MB)I-EN-18-008.pdf (2.3 MB)
Evluation I-EN-18-009.pdf (294.5 KB)I-MI-18-001.pdf (1.4 MB)I-QC-18-007.pdf (1020.8 KB)
I-TT-18-001.pdf (2.2 MB)I-TT-18-002.pdf (1.2 MB)I-TT-18-003.pdf (1.4 MB)
Quality Tracker 2018.pdf (190.1 KB)Quality Tracker 2018.xlsx (262.0 KB)CAPA Tracking List.xls (751 KB)Required CAPA of OOS_2018_All.xls (2.1 MB)
Required CAPA of OOS_2018_QC.xls (2.1 MB)OOT,OOE TRACKING 2018 22-Dec-18.xlsx (868.7 KB)
Phase-II Investigation status 12-Dec-18.xlsx (2.7 MB)Data of OOS_2017 II.xlsx (1.4 MB)Product Complaint Tracker 2018.xls (127 KB)


(YOGESH NARKHEDE) #71

Copy of New Microsoft Excel Worksheet.xlsx (11.2 KB)
New Microsoft Excel Worksheet.xlsx (11.2 KB)
rahul apr.pdf (73.2 KB)
rahul feb.pdf (73.3 KB)
rahul jan.pdf (73.2 KB)
rahul jul.pdf (73.3 KB)
rahul jun.pdf (73.8 KB)
rahul march.pdf (73.3 KB)
rahul may.pdf (73.3 KB)
rahul_apr.docx (18.8 KB)
rahul_aug.docx (19.2 KB)
rahul_feb.docx (18.8 KB)
rahul_jan.docx (18.7 KB)
rahul_jul.docx (19.0 KB)
rahul_jun.docx (18.8 KB)
rahul_march.docx (18.8 KB)
rahul_may.docx (18.8 KB)
rahul_sep.docx (21.5 KB)
yogesh.pdf (73.1 KB)Copy of New Microsoft Excel Worksheet.xlsx (11.2 KB)
oct-17.docx (18.8 KB)
rahul_aug.docx (19.2 KB)
rahul_aug1.docx (19.2 KB)
rahul_jul.docx (19.0 KB)
rahul_jul1.docx (24.2 KB)
rahul_jun.docx (18.8 KB)
rahul_jun1.docx (24.0 KB)
rahul_sep.docx (24.7 KB)oct-17.docx (18.7 KB)


(YOGESH NARKHEDE) #72


(YOGESH NARKHEDE) #73

Sampling, Testing, Release and Rejection of Raw material78934Annexure31.docx (39.6 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure32.docx (43.7 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure33.docx (40.9 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure34.docx (42.3 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure35.docx (43.2 KB)
Sampling, Testing, Release and Rejection of Raw material78934Attachment2Gowningprocedure.docx (23.5 KB)

analytical working standards and reference standards.docx (88.0 KB)
analytical working standards and reference standards78198Annexure1.docx (46.7 KB)
analytical working standards and reference standards78198Annexure2.docx (46.7 KB)
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analytical working standards and reference standards78198Annexure4.docx (46.4 KB)
analytical working standards and reference standards78198Annexure5.docx (46.1 KB)
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analytical working standards and reference standards78198Annexure11.docx (45.3 KB)
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analytical working standards and reference standards78198Annexure15.docx (46.0 KB)
analytical working standards and reference standards78198Annexure18.docx (42.9 KB)
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analytical working standards and reference standards78198Annexure21.docx (47.6 KB)
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breakdown of Instruments Equipments in the QC 77110Annexure2.docx (49.4 KB)
breakdown of Instruments Equipments in the QC 77110Annexure3.docx (43.3 KB)
breakdown of Instruments Equipments in the QC.docx (64.3 KB)
Certificate of Analysis in the QC.docx (63.3 KB)
Certificate of Analysis in the QC80104AnnexureI.docx (46.3 KB)
Certificate of Analysis in the QC80104AnnexureII.docx (45.7 KB)
Certificate of Analysis in the QC80104AContract of QC Instruments, Equipments 5034AnnexureVIII.docx (43.6 KB)
Contract of QC Instruments, Equipments 65034AnnexureIII.docx (43.5 KB)
Contract of QC Instruments, Equipments 65034AnnexureIV.docx (43.7 KB)
Contract of QC Instruments, Equipments 65034AnnexureIX.docx (43.7 KB)
Contract of QC Instruments, Equipments 65034AnnexureV.docx (43.9 KB)
Contract of QC Instruments, Equipments 65034AnnexureVI.docx (43.5 KB)
Contract of QC Instruments, Equipments 65034AnnexureVII.docx (43.9 KB)
Contract of QC Instruments, Equipments 65034AnnexureX.docx (42.9 KB)
Contract of QC Instruments, Equipments 65034AnnexureXI.docx (44.5 KB)
Contract of QC Instruments, Equipments 65034AnnexureXII.docx (44.6 KB)
Contract of QC Instruments, Equipments AnnexureI.docx (43.4 KB)
Contract of QC Instruments, Equipments.docx (84.0 KB)
Contract of QC Instruments, Equipments65034AnnexureII.docx (43.6 KB)
nnexureIII.docx (45.5 KB)
Certificate of Analysis in the QC80104AnnexureIv.docx (45.8 KB)Disintegration Test Apparatus 75249Annexure1.docx (48.3 KB)
Disintegration Test Apparatus 75249Annexure2.docx (46.3 KB)
Disintegration Test Apparatus.docx (215.1 KB)Dissolution test Apparatus78935Annexure1.docx (61.2 KB)
Dissolution test Apparatus78935Annexure2.docx (47.2 KB)
Dissolution test Apparatus78935Annexure2A.docx (47.1 KB)
Dissolution test Apparatus78935Annexure2B.docx (47.0 KB)
Dissolution test Apparatus78935Annexure2C.docx (54.9 KB)
Dissolution test Apparatus78935Annexure3.docx (48.3 KB)
Dissolution test Apparatus78935Annexure4.docx (47.9 KB)Good Chromatographic practices.docx (2.6 MB)HPLC, GC and UV-Visible Spectrophotometer 74807AnnexureI.docx (43.7 KB)
HPLC, GC and UV-Visible Spectrophotometer 74807AnnexureII.docx (43.5 KB)
HPLC, GC and UV-Visible Spectrophotometer 74807AnnexureIII.docx (43.7 KB)
HPLC, GC and UV-Visible Spectrophotometer 74807AnnexureIV.docx (43.7 KB)
HPLC, GC and UV-Visible Spectrophotometer 74807AnnexureV.docx (44.7 KB)
HPLC, GC and UV-Visible Spectrophotometer 74807AnnexureVI.docx (44.8 KB)
HPLC, GC and UV-Visible Spectrophotometer 74807AnnexureVII.docx (43.6 KB)
HPLC, GC and UV-Visible Spectrophotometer 74807AnnexureVIII.docx (43.8 KB)
HPLC, GC and UV-Visible Spectrophotometer.docx (81.6 KB)Investigation of Laboratory Errors.docx (94.1 KB)
Investigation of Laboratory Errors79039Annexure1.docx (50.8 KB)
Investigation of Laboratory Errors79039Annexure2.docx (43.5 KB)
Investigation of Laboratory Errors79039Annexure3.docx (44.5 KB)
Investigation of Laboratory Errors79039Annexure4.docx (55.9 KB)Karl Fisher Autotitrator and Coulometer. 77981Annexure1.docx (43.3 KB)
Karl Fisher Autotitrator and Coulometer. 77981Annexure2.docx (45.5 KB)
Karl Fisher Autotitrator and Coulometer…docx (255.9 KB)
malvern particle size analyzer.docx (69.1 KB)
Out-of-Trend results and Out-of-Expectation 78520Annexure1.docx (61.4 KB)
Out-of-Trend results and Out-of-Expectation 78520Annexure2.docx (48.9 KB)
Out-of-Trend results and Out-of-Expectation 78520Annexure3.docx (42.8 KB)
Out-of-Trend results and Out-of-Expectation.docx (76.1 KB)rounding of analytical figures.docx (64.8 KB)
Sampling, Testing, Release and Rejection of Raw material.docx (101.6 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure1.docx (46.0 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure2.docx (49.9 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure3.docx (73.9 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure4.docx (71.8 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure5.docx (44.0 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure9.docx (42.8 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure10.docx (45.9 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure11.docx (47.0 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure13.docx (43.2 KB)
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Sampling, Testing, Release and Rejection of Raw material78934Annexure31.docx (39.6 KB)
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Sampling, Testing, Release and Rejection of Raw material78934Annexure1.docx (46.0 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure2.docx (49.9 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure3.docx (73.9 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure4.docx (71.8 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure5.docx (44.0 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure9.docx (42.8 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure10.docx (45.9 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure11.docx (47.0 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure13.docx (43.2 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure14.docx (47.4 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure15.docx (43.8 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure16.docx (47.3 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure17.docx (44.1 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure18.docx (159.7 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure19.docx (55.8 KB)Sampling, Testing, Release and Rejection of Raw material78934Annexure21.docx (50.6 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure22.docx (40.1 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure23.docx (41.7 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure24.docx (40.3 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure25.docx (39.8 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure26.docx (39.7 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure27.docx (39.5 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure28.docx (43.1 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure29.docx (820.5 KB)
Sampling, Testing, Release and Rejection of Raw material78934Annexure30.docx (39.5 KB)Tablet Hardness Tester 81033Annexure1.docx (43.1 KB)
Tablet Hardness Tester 81033Annexure2.docx (46.5 KB)
Tablet Hardness Tester 81033Annexure3.docx (485.5 KB)
Tablet Hardness Tester 81033Annexure4.docx (543.4 KB)
Tablet Hardness Tester 81033Annexure5.docx (43.7 KB)
Tablet Hardness Tester.docx (4.2 MB)Tap Density Apparatus Annexure1.docx (43.9 KB)
Tap Density Apparatus.docx (79.7 KB)Testing, Release and Rejection of Semi-finished and Finished Products.docx (77.9 KB)
Testing, Release and Rejection of Semi-finished and Finished Products78566AnnexureI.docx (43.3 KB)
Testing, Release and Rejection of Semi-finished and Finished Products78566AnnexureII.docx (43.3 KB)
Testing, Release and Rejection of Semi-finished and Finished Products78566AnnexureIII.docx (43.3 KB)
Testing, Release and Rejection of Semi-finished and Finished Products78566AnnexureIV.docx (43.3 KB)
Testing, Release and Rejection of Semi-finished and Finished Products78566AnnexureV.docx (46.3 KB)
Testing, Release and Rejection of Semi-finished and Finished Products78566AnnexureVI.docx (46.3 KB)
Testing, Release and Rejection of Semi-finished and Finished Products78566AnnexureVII.docx (45.5 KB)Validation Of An Analyst In Quality Control Laboratory.docx (67.9 KB)
Validation Of An Analyst In Quality Control Laboratory79038AnnexureI.docx (46.0 KB)
Validation Of An Analyst In Quality Control Laboratory79038AnnexureII.docx (47.2 KB)
Validation Of An Analyst In Quality Control Laboratory79038AnnexureIII.docx (44.4 KB)
Validation Of An Analyst In Quality Control Laboratory79038AnnexureIV.docx (46.2 KB)
Validation of Excel Sheets. AnnexureI.docx (43.9 KB)
Validation of Excel Sheets…docx (75.2 KB)
walk in type stability chamber 74092Annexure2.docx (44.7 KB)
walk in type stability chamber 74092Annexure3.docx (43.8 KB)
walk in type stability chamber 74092Annexure4.docx (46.2 KB)
walk in type stability chamber 74092Annexure5.docx (47.0 KB)
walk in type stability chamber.docx (74.9 KB)
walk in type stability chamber74092Annexure1.docx (44.7 KB)


(YOGESH NARKHEDE) #74

control of Batch Manufacturing Record and Batch Packing Record AnnexureVI.docx (50.4 KB)
control of Batch Manufacturing Record and Batch Packing Record AnnexureVII.docx (50.6 KB)
control of Batch Manufacturing Record and Batch Packing Record. AnnexureI.docx (49.8 KB)
control of Batch Manufacturing Record and Batch Packing Record. AnnexureII.docx (50.0 KB)
control of Batch Manufacturing Record and Batch Packing Record. AnnexureIII.docx (50.1 KB)
control of Batch Manufacturing Record and Batch Packing Record. AnnexureIV.docx (50.3 KB)
control of Batch Manufacturing Record and Batch Packing Record. AnnexureIX.docx (48.9 KB)
control of Batch Manufacturing Record and Batch Packing Record. AnnexureV.docx (48.5 Kdisposition of components and products AnnexureI.docx (45.9 KB)
disposition of components and products.docx (78.8 KB)
B)
control of Batch Manufacturing Record and Batch Packing Record. AnnexureVIII.docx (47.0 KB)
control of Batch Manufacturing Record and Batch Packing Record…docx (84.8 KB)

23 station double rotary Sejong Compression machine Annexure-IIRecordingofAWCparameters.docx (32.9 KB)
23 station double rotary Sejong Compression machine AnnexureIProductchangeovercleaningchecklist.docx (54.4 KB)
23 station double rotary Sejong Compression machine AttachmentI-HardtocleanareaCompressionmachine.docx (438.6 KB)
23 station double rotary Sejong Compression machine AttachmentII-Batchchangeovercleaningchecklist.docx (44.2 KB)
23 station double rotary Sejong Compression machine AttachmentIIIWorkInstruction.docx (44.8 KB)
23 station double rotary Sejong Compression machine.docx (4.9 MB)APCG 800 AnnexureII.docx (50.8 KB)
APCG 800 AnnexureIII.docx (46.3 KB)
APCG 800 PR.EQP.054.docx (39.5 KB)
APCG 800 PREQP054WORKINSTRUCTION.docx (42.1 KB)Autocoater. AnnexureII.docx (46.3 KB)
Autocoater. AnnexureIII.docx (42.9 KB)
Autocoater. PR.EQP.016.docx (39.5 KB)
Autocoater. PREQP016WORKINSTRUCTION.docx (41.1 KB)
Autocoater…docx (2.9 MB)
bulk packing AnnexureI.docx (46.9 KB)
bulk packing AnnexureII.docx (57.0 KB)
bulk packing AnnexureIII.docx (47.2 KB)
bulk packing SOP.docx (78.2 KB)cage Blender AnnexureII.docx (49.8 KB)
cage Blender PR.EQP.013.docx (39.5 KB)
cage Blender PREQP013WORKINSTRUCTION.docx (41.2 KB)CAPSULES WT VARIATION SOP.docx (87.1 KB)
cleaning and destruction of finger bag. AnnexureI.docx (45.5 KB)
cleaning and destruction of finger bag. AnnexureII.docx (45.8 KB)
cleaning and destruction of finger bag…docx (79.7 KB)
Cleaning and operation of Metal Detector AnnexureI.docx (321.4 KB)
Cleaning and operation of Metal Detector.docx (135.9 KB)
Cleaning and Operation of Secondary Packing line AnnexureI.docx (45.8 KB)
Cleaning and Operation of Secondary Packing line.docx (88.6 KB)CLEANING OPERATION OD PRIMRY PACKING AREA SOP.docx (101.0 KB)
coating pan 60 AnnexureII.docx (46.1 KB)
coating pan 60 AnnexureIII.docx (43.9 KB)
<a class=“attachment” href="/uploads/default/oCo-mill AnnexureII.docx (44.4 KB)
Co-mill PR.EQP.017.docx (40.4 KB)
Co-mill PREQP017WORKINSTRUCTION.docx (39.2 KB)
Co-mill.docx (998.5 KB)
riginal/2X/f/f6cd87817101cea659a9703741be8e2bb1188533.docx">coating pan 60 PR.EQP.024.docx (39.6 KB)
coating pan 60 PREQP024WORKINSTRUCTION.docx (41.0 KB)
coating pan 60.docx (333.3 KB)Fluid Bed Dryer 1300 liters fbd1200AnnexureIII.docx (41.6 KB)
Fluid Bed Dryer 1300 liters FBDPTOPAnnexureII.docx (51.6 KB)
Fluid Bed Dryer 1300 liters PR.EQP.106.docx (41.9 KB)
Fluid Bed Dryer 1300 liters PREQP0106WORKINSTRUCTION.docx (40.9 KB)
Fluid Bed Dryer 1300 liters.docx (2.0 MB)
handling of equipment breakdown.docx (84.1 KB)
Hydraulic IPC Mobile Lifter.docx (75.4 KB)
In-process quality checks.docx (78.9 KB)
Inspection Of Tablets Capsules AnnexureI.docx (45.5 KB)
Inspection Of Tablets Capsules AnnexureII.docx (224.2 KB)
Inspection Of Tablets Capsules AnnexureIII.docx (47.4 KB)
Inspection Of Tablets Capsules AnnexureIV.docx (47.4 KB)
Inspection Of Tablets Capsules AnnexureV.docx (47.3 KB)
Inspection Of Tablets Capsules.docx (83.1 KB)
labeling in production area AnnexureI.docx (3.4 MB)
labeling in production area.docx (71.4 KB)
leak test apparatus.docx (81.0 KB)maintaining the equipment log book AnnexureI.docx (45.7 KB)
maintaining the equipment log book AnnexureII.docx (45.9 KB)
maintaining the equipment log book AnnexureIII.docx (45.7 KB)
maintaining the equipment log book.docx (77.0 KB)
major breakdown AnnexureI.docx (44.9 KB)
major breakdown SOP.docx (88.3 KB)
material movement in production area AnnexureI.docx (61.5 KB)
material movement in production area AnnexureII.docx (45.9 KB)
material movement in production area AnnexureIII.docx (51.2 KB)
material movement in prodmovable Equipments AnnexureI.docx (41.5 KB)
movable Equipments.docx (74.9 KB)
Octagonal Blender 2000 liters AnnexureII.docx (45.1 KB)
Octagonal Blender 2000 liters Annexure-IIIPRODUCTCHANGEOVER.docx (34.7 KB)
Octagonal Blender 2000 liters PR.EQP.005.docx (39.8 KB)
Octagonal Blender 2000 liters PREQP005WORKINSTRUCTION.docx (41.9 KB)
Octagonal Blender 2000 liters.docx (4.1 MB)
uction area AnnexureIV.docx (46.4 KB)
material movement in production area.docx (90.3 KB)
operation of combo metal detector cum deduster AttachmentI-Hardtocleanareametaldetectorcumdeduster.docx (781.6 KB)
operation of combo metal detector cum deduster.docx (3.5 MB)operation of IR Dryer AnnexureI.docx (49.9 KB)
operation of IR Dryer.docx (92.0 KB)
Pass box. AnnexureI.docx (43.3 KB)
Pass box…docx (84.4 KB)
Procedure for opening and closing of production department.docx (85.3 KB)
Procedure for opening and closing of production department AnnexureI.docx (42.9 KB)
Procedure for opening and closing of production department AnnexureII.docx (43.5 KB)
Procedure for Storage, Cleaning and Inspection of non-moving ancillary equipments. AnnexureI.docx (41.9 KB)
Procedure for Storage, Cleaning and Inspection of non-moving ancillary equipments…docx (82.6 KB)
procurement, receipt, storage, issue, return and destruction of change parts of packing machines.docx (81.9 KB)
return and destruction of change parts of packing machines AnnexureII.docx (43.5 KB)
return and destruction of change parts of packing machines AnnexureIII.docx (42.8 KB)
return and destruction of change parts of packing machines AnnexureIV.docx (43.6 KB)
return and destruction of change parts of packing machines AnnexureIX.docx (48.8 KB)
return and destruction of change parts of packing machines AnnexureV.docx (43.4 KB)
return and destruction of change parts of packing machines AnnexureVI.docx (45.6 KB)
return and destruction of change parts of packing machines AnnexureVII.dPUNCH SOP AnnexureIIIPRGEN023F-03.docx (25.1 KB)
PUNCH SOP AnnexureIIPRGEN023F-02.docx (25.3 KB)
PUNCH SOP AnnexureI-PRGEN023F-01.docx (26.4 KB)
PUNCH SOP AnnexureIV-PRGEN023F-04.docx (25.6 KB)
PUNCH SOP AnnexureVIII-PRGEN023F-08.docx (25.4 KB)
PUNCH SOP AnnexureVII-PRGEN023F-07.docx (40.2 KB)
<a class=“attachment” href="/uploads/defaulpurified water for manufacturing and cleaning purpose in production area…docx (83.7 KB)
Rapid Mixer Granulator 1200 Liters AnnexureII.docx (46.7 KB)
Rapid Mixer Granulator 1200 Liters AttachmentIV-WorkInstructions.docx (41.1 KB)
Rapid Mixer Granulator 1200 Liters PR.EQP.015.docx (41.0 KB)
Rapid Mixer Granulator 1200 Liters.docx (2.4 MB)
t/original/2X/f/f24c1c96e2bfff2d4f0cf8e9bbd9867a0831d079.docx">PUNCH SOP AnnexureVI-PRGEN023F-06.docx (27.3 KB)
PUNCH SOP AnnexureV-PRGEN023F-05.docx (38.0 KB)
PUNCH SOP.docx (861.4 KB)
ocx (49.1 KB)
return and destruction of change parts of packing machines AnnexureVIII.docx (49.0 KB)
return and destruction of change parts of packing machines AnnexureX.docx (45.7 KB)receipt of dispensed Raw material, Primary packing material AnnexureI.docx (46.9 KB)
receipt of dispensed Raw material, Primary packing material AnnexureII.docx (47.0 KB)
receipt of dispensed Raw material, Primary packing material AnnexureIII.docx (45.7 KB)
receipt of dispensed Raw material, Primary packing material.docx (81.8 KB)
sieves and screens SOP AnnexureI.docx (45.2 KB)
sieves and screens SOP AnnexureIII.docx (45.3 KB)
sieves and screens SOP AnnexureIV.docx (1.1 MB)
sieves and screens SOP AnnexureV.docx (42.4 KB)
sieves and screens SOP AnnexureVI.docx (45.5 KB)
sieves and screens SOP AnnexureVII.docx (42.7 KB)
sieves and screens SOP AnnexureVIII.docx (46.6 KB)
sieves and screens SOP.docx (2.0 MB)
sieves and screens SOPAnnexureII.docx (45.6 KB)
Silicon Tube. SOP AnnexureI.docx (44.8 KB)
Silicon Tube. SOP AnnexureII.docx (44.8 KB)
Silicon Tube. SOP AnnexureIII.docx (44.8 KB)
Silicon Tube. SOP.docx (87.5 KB)spray rate of solutionsuspension. AnnexureI.docx (42.3 KB)
spray rate of solutionsuspension…docx (73.9 KB)
Tablet and Capsules Inspection machine. AnnexureI.docx (46.0 KB)
Tablet and Capsules Inspection machine. Annexure-II.docx (46.8 KB)
Tablet and Capsules Inspection machine. Annexure-III.docx (44.2 KB)
<a class=“attachment” href="/uploadTantrasoft In-Process Checks System.docx (86.2 KB)
TEEPOL 1.0%VV SOP AnnexureI.docx (46.6 KB)
TEEPOL 1.0%VV SOP AnnexureII.docx (42.8 KB)
TEEPOL 1.0%VV SOP.docx (76.0 KB)
vacuum transfer system AnnexureI.docx (45.6 KB)
vacuum transfer system AnnexureII.docx (42.5 KB)
vacuum transfer system.docx (82.4 KB)
weighing balance. SOP AnnexureI.docx (48.6 KB)
weighing balance. SOP AnnexureII.docx (50.9 KB)
weighing balance. SOP AnnexureIII.docx (50.7 KB)
weighing balance. SOP AnnexureIXBottlechallengetest.docx (51.3 KB)
weighing balance. SOP AnnexureV.docx (59.8 KB)
weighing balance. SOP AnnexureVII.docx (45.3 KB)
weighing balance. SOP AnnexureVIIICartonchallengetest.docx (51.5 KB)
weighing balance. SOP AnnexureVIlistofweightstobetakenfornoncriticalbal.docx (57.9 KB)
weighing balance. SOP.docx (3.2 MB)
s/default/original/2X/5/5d0cba974e52fd6ab5895d34062941f21714a622.docx">Tablet and Capsules Inspection machine. Annexure-IV.docx (45.4 KB)
Tablet and Capsules Inspection machine…docx (65.3 KB)


(YOGESH NARKHEDE) #75

Amaryl M Forte 1 mg Queries pdf.pdf (220.5 KB)
Amaryl M Forte 1 mg Queries.docx (17.5 KB)
Amaryl M Forte 1 mgTrend chatrts.xlsx (57.2 KB)
APR_ Amaryl M Forte 1 mg - I QA 18 009 pdf .pdf (1.6 MB)
APR_ Amaryl M Forte 1 mg - I QA 18 009.doc (1.8 MB)
APR_ Amaryl M Forte 1 mg PDF.pdf (1.6 MB)
APR_ Amaryl M Forte 1 mg.doc (1.8 MB)
CPK Assay FP.DOCX (315.2 KB)
Cpk.DOCX (415.0 KB)Addendum (Met 500 Pio 15).docx (56.4 KB)
APR Cetapin P 15 - I QA 18 009 pdf.pdf (1.1 MB)
APR Cetapin P 15 - I QA 18 009.docx (630.9 KB)
APR Cetapin P 15 PDF.pdf (1.1 MB)
APR Cetapin P 15.docx (630.8 KB)
Cetapin P 15 APR Queries pdf.pdf (221.7 KB)
Cetapin P 15 APR Queries.docx (17.4 KB)
CPK FP Assay.DOCX (253.7 KB)
cpk.DOCX (332.7 KB)
Trend charts Cetapin P 15.xlsx (43.2 KB)Addendum (pregaba 75 Methyl 1500).docx (82.0 KB)
APR Pregabalin 75 mg Methylcobalamin 1500 mcg 1.docx (111.8 KB)
Trend charts Rejusite Tablets.xls (196.5 KB)Addendum (Met 500 Vogli 0.3).docx (69.8 KB)
APR CETAPIN V 0 3 mg - I QA 18 009 pdf .pdf (1.2 MB)
APR CETAPIN V 0.3 mg - I QA 18 009.docx (665.8 KB)
APR Cetapin V 0.3 mg PDF.pdf (1.2 MB)
APR CETAPIN V 0.3 mg.docx (665.7 KB)
Cetapin V 0.3 APR corrections.docx (17.4 KB)
Cetapin V 0.3 APR Queries pdf…pdf (220.4 KB)
CPK FP Assay.DOCX (310.6 KB)
cpk.DOCX (408.0 KB)
Stability Cetapin V 0.3 mg.pdf (164.0 KB)
Trend charts Cetapin V 0.3 mg.xlsx (44.4 KB)APR_Metbay 500 mg.docx (161.5 KB)
APR_Metbay 500 mg.pdf (738.5 KB)
Trend chart Metformin Hcl SR Tablets 500 mg.xlsx (35.9 KB)Incid MD.doc (803.5 KB)
Incid MD.pdf (714.8 KB)
Trend charts.xlsx (30.3 KB)APR_Pregabaline SR 75 mg - PDF.doc (334.5 KB)
APR_Pregabaline SR 75 mg.doc (337 KB)
Nova SR Tablets 75 mg- APR.pdf (439.1 KB)
Trend of Nova SR.docx (33.8 KB)
Trend of Nova SR.xlsx (30.7 KB)
APR_Triexer LS 1 PDF.pdf (677.3 KB)
APR_Triexer LS 1.doc (1.3 MB)
Trend Charts for Triexer LS 1.xlsx (43.0 KB)APR- Triexer LS 2.doc (1.8 MB)
APR- Triexer LS 2.pdf (856.2 KB)
Trend Charts Triexer LS 2.xlsx (41.8 KB)Glimy- MP 1 PDF.pdf (715.0 KB)
Glimy- MP 1.doc (170.5 KB)APR Met US 500.pdf (2.3 MB)
Trend charts Met USP 500 mg.pdf (866.9 KB)APR Telmi 20.pdf (237.7 KB)
APR Telmi 40.pdf (240.7 KB)
APR Telmi 80.pdf (250.0 KB)
Trend charts Telmisartan Tablets USP 20 mg.pdf (189.3 KB)
Trend charts Telmisartan Tablets USP 40 mg.pdf (194.8 KB)
Trend charts Telmisartan Tablets USP 80 mg.pdf (196.7 KB)APR Common Granules for Telmisartan 20 40 80 mg- 1.pdf (571.5 KB)
Trend chart C.B. for Telmi 20, 40 and 80 mg PDF.pdf (180.7 KB)Parit D.doc (692.5 KB)
Parit D.pdf (684.5 KB)
Trend charts Rabe 20 Dome 30.xls (134 KB)
APR Eprisan DSR.pdf (1.2 MB)
Eprisan DSR.doc (1.7 MB)
Trend charts of Eperison 150 Diclo 100 mg.xlsx (60.5 KB)APR Cetapin P 15 - I QA 18 009 pdf.pdf (1.1 MB)
APR Cetapin P 15 PDF.pdf (1.1 MB)
Cetapin P 15 APR Queries pdf.pdf (221.7 KB)
Trend charts Cetapin P 15.xlsx (43.2 KB)APR_Panfor 500 mg.docx (343.0 KB)
APR_Panfor 500 mg.pdf (1.6 MB)
Trend chart Panfor SR Tablets 500 mg.xlsx (104.6 KB)APR_EC Rabeprazole 10 mg cap pdf.pdf (505.1 KB)
APR_EC Rabeprazole 10 mg cap.docx (157.5 KB)
Trend charts Rabe 10 Cap…xls (114.5 KB)APR Colestrim.pdf (736.7 KB)APR of Limzer.docx (203.2 KB)
Trend charts.xlsx (81.8 KB)
Trend.docx (122.2 KB)


(YOGESH NARKHEDE) #76

Quality Tracker 2018.xlsx (407.9 KB)Quality Tracker 18 Corporate Deviation.xls (1.6 MB)Quality Tracker 18 Corporate FIR.xls (2.1 MB)Quality Tracker 18 Nutra Incident.xls (2.1 MB)Quality Tracker 2018.xlsx (265.5 KB)Quality tracker-2018.xlsx (189.5 KB)Quality Tracker 2018.xlsx (265.5 KB)CAPA Tracking List.xls (751 KB)CAPA effectiveness Tracking List 2018.xls (198 KB)
Required CAPA of OOS_2018_All.xls (2.1 MB)
Required CAPA of OOS_2018_QC.xls (2.1 MB)OOT,OOE TRACKING 2018 22-Dec-18.xlsx (914.7 KB)
Phase-II Investigation status 12-Dec-18.xlsx (2.7 MB)Uploading: Abbott.xlsx… Ascend.xlsx (8.1 KB)
Copy of Annexure-1 DRL -OCT -18 (JAMMU - AMBERNATH).xlsx (14.3 KB)
Ascend.xlsx (8.1 KB)
Ascend.xlsx (8.1 KB)
Ascend.xlsx (8.1 KB)
Sandoz.xlsx (8.1 KB)
Ascend.xlsx (8.1 KB)
Wave pharma.xlsx (8.2 KB)
Ascend.xlsx (8.1 KB)Quality tracker 2017…xlsx (219.5 KB)
2017 Major Deviation.xlsx (135.5 KB)
Quality tracker for Site deviation 2017.xls (666.5 KB)CAPA effectiveness Tracking List 2017.xls (238 KB)QMS trend Aceclo.xlsx (102.4 KB)
QMS trend Ambro.xlsx (11.6 KB)
<a class=“attachment” href="/uploads/defaulGeneric Quality Tracker 17.xls (102 KB)
Product Complaint Tracker 17.xls (79 KB)
Sandoz Product complaints.xlsx (9.8 KB)
sanofi list.xlsx (2.0 MB)
t/original/2X/5/54121dc0eed23a2241fb599884d8dc25b684d708.xlsx">QMS trend Levo data.xlsx (12.9 KB)Engineering 2016 Root cause.xlsx (20.9 KB)
Excise 2016 Root cause.xlsx (9.0 KB)
IT 2016 Root cause (site).xlsx (9.0 KB)
PA 2016 Root cause.xlsx (9.2 KB)
Production 2016 Root cause.xlsx (109.1 KB)
Quality Assurance 2016 Root cause.xlsx (36.9 KB)
Quality control 2016 Root cause.xlsx (25.5 KB)
Quality Tracker 2016.xls (397.5 KB)
store 2016 Root cause.xlsx (18.2 KB)
TT 2016 Root cause.xlsx (15.5 KB)2016 Major Deviation.xlsx (34.1 KB)
Quality tracker of site deviation 2016.xls (292 KB)
Quality Tracker.xls (35 KB)<a class=“attachment” href="/uploads/default/original/2X/d/dfe1729ad14b650207faf977d998a2d7c60OOT,OOE TRACKING 11-05-2018…xlsx (1.7 MB)
64539.xls">Generic Quality Tracker 14 Mar.16.xls (102 KB)
OOS status 2016.xls (52.5 KB)


(YOGESH NARKHEDE) #77

ANDA submission through Pharmaready software eCTD preparation 1.docx (4.8 MB)ANDA submission through Pharmaready software eCTD preparation 2.docx (4.7 MB)Annual report submission to US SOP.docx (69.9 KB)
Dossier SOP.docx (36.8 KB)
FDA LIECENCE SOP.docx (63.4 KB)
Dossier SOP.docx (36.8 KB)
PERIODIC SAFTY UPDATE RPORT SOP.docx (64.5 KB)
FDA LIECENCE SOP.docx (63.4 KB)
RA new person Certificate.docx (63.1 KB)
ROW.docx (19.3 KB)GDP SOP.docx (132.3 KB)SPECI AND MOA SOP.docx (92.1 KB)
SPECI AND MOA SOP lAnnexureXV.docx (46.6 KB)
SPECI AND MOA SOP lAnnexureXIII.docx (69.4 KB)


(YOGESH NARKHEDE) #78

C.PR.18.002.pdf (1.4 MB)
C.PR.18.003.pdf (1.1 MB)
C.PR.18.004.pdf (3.2 MB)C.PR.18.006.pdf (851.1 KB)
C.PR.18.007.pdf (1.7 MB)C.PR.18.008.pdf (4.7 MB)C.PR.18.009.pdf (2.9 MB)
C.PR.18.010.pdf (2.5 MB)C.PR.18.016.pdf (2.2 MB)
C.PR.18.015.pdf (3.7 MB)C.PR.18.019.pdf (2.6 MB)
C.PR.18.025.pdf (1.1 MB)
C.PR.18.026.pdf (539.7 KB)C.PR.18.027.pdf (3.5 MB)
C.PR.18.028.pdf (1.7 MB)C.PR.18.030.pdf (2.1 MB)
C.PR.18.036.pdf (2.0 MB)C.PR.18.043 .pdf (1.5 MB)
C.PR.18.045.pdf (1.4 MB)
C.PR.18.053.pdf (2.7 MB)C.PR.18.050.pdf (4.7 MB)C.PR.18.057.pdf (2.5 MB)
C.PR.18.059.pdf (2.3 MB)
C.PR.18.060.pdf (2.3 MB)C.PR.18.064.pdf (3.3 MB)
C.PR.18.065.pdf (2.7 MB)
C.PR.18.066.pdf (290.2 KB)C.PR.18.067.pdf (1.8 MB)
C.PR.18.071.pdf (3.5 MB)
C.PR.18.072.pdf (933.9 KB)
C.PR.18.077.pdf (620.4 KB)
C.PR.18.084.pdf (1.7 MB)
C.PR.18.115.pdf (422.3 KB)C.PR.18.079.pdf (2.5 MB)C.CQ.18.001.pdf (3.0 MB)
C.CQ.18.004.pdf (2.2 MB)C.BD.18.003.pdf (3.2 MB)
C.BD.18.006.pdf (3.7 MB)C.BD.18.012.pdf (868.6 KB)
C.BD.18.013.pdf (917.9 KB)
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C.BD.18.018.pdf (2.2 MB)C.BD.18.034.pdf (1.5 MB)
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C.BD.18.071.pdf (4.2 MB)C.BD.18.079.pdf (4.5 MB)C.BD.18.087.pdf (3.2 MB)
C.BD.18.093.pdf (3.8 MB)C.PR.18.002.pdf (1.4 MB)
C.PR.18.003.pdf (1.1 MB)
C.PR.18.004.pdf (3.2 MB)C.PR.18.006.pdf (851.1 KB)
C.PR.18.007.pdf (1.7 MB)
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C.PR.18.066.pdf (290.2 KB)C.PR.18.057.pdf (2.5 MB)
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C.PR.18.065.pdf (2.7 MB)C.PR.18.067.pdf (1.8 MB)
C.PR.18.071.pdf (3.5 MB)
C.PR.18.072.pdf (933.9 KB)C.PR.18.079.pdf (2.5 MB)
C.PR.18.084.pdf (1.7 MB)
C.PR.18.092.pdf (1.4 MB)
C.PR.18.115.pdf (422.3 KB)C.BD.18.034.pdf (1.5 MB)
C.BD.18.003.pdf (3.2 MB)
C.BD.18.012.pdf (868.6 KB)
C.BD.18.013.pdf (917.9 KB)C.BD.18.006.pdf (3.7 MB)C.BD.18.041.pdf (2.3 MB)
C.BD.18.049.pdf (880.8 KB)C.BD.18.087.pdf (3.2 MB)C.BD.18.079.pdf (4.5 MB)C.BD.18.071.pdf (4.2 MB)C.AD.18.003.pdf (3.8 MB)
C.AD.18.005.pdf (2.2 MB)C.AD.18.034.pdf (2.4 MB)
C.AD.18.037.pdf (3.8 MB)C.AD.18.029.pdf (2.2 MB)
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C.AD.18.026.pdf (2.8 MB)C.AD.18.019.pdf (2.2 MB)
C.AD.18.020.pdf (2.2 MB)C.FD.18.003.pdf (1.9 MB)
C.FD.18.004.pdf (2.2 MB)
C.FD.18.013.pdf (2.9 MB)C.FD.18.011.pdf (3.3 MB)
C.FD.18.014.pdf (2.7 MB)C.FD.18.015.pdf (2.3 MB)
C.FD.18.031.pdf (2.1 MB)C.MI.18.001.pdf (4.3 MB)
C.MI.18.002.pdf (2.1 MB)C.PU.18.001.pdf (4.3 MB)
C.PU.18.007.pdf (593.7 KB)C.PU.18.002.pdf (4.2 MB)
C.PU.18.006.pdf (1.9 MB)C.PU.18.013.pdf (4.3 MB)
C.PU.18.015.pdf (1.3 MB)C.PU.18.021.pdf (3.3 MB)
C.PU.18.031.pdf (1.2 MB)C.QC.18.003.pdf (2.4 MB)
C.QC.18.004.pdf (3.2 MB)C.QC.18.005.pdf (2.4 MB)
C.QC.18.007.pdf (2.5 MB)C.QC.18.009.pdf (3.6 MB)
C.QC.18.010.pdf (3.4 MB)C.QC.18.011.pdf (3.8 MB)C.QC.18.019.pdf (4.7 MB)
C.QC.18.021.pdf (670.2 KB)C.QC.18.024.pdf (2.1 MB)
C.QC.18.025.pdf (2.6 MB)C.QC.18.027 .pdf (2.9 MB)
C.QC.18.029.pdf (1.7 MB)Quality Tracker 2018.xlsx (407.9 KB)C.CQ.18.001.pdf (3.0 MB)C.RE.18.002.pdf (1.7 MB)


(YOGESH NARKHEDE) #79

AIR COMPRESSOR SOP AnnexureII.docx (45.9 KB)
AIR COMPRESSOR SOP AnnexureIII.docx (48.1 KB)
AIR COMPRESSOR SOP AnnexureX.docx (45.6 KB)
AIR COMPRESSOR SOP AnnexureXII.docx (45.2 KB)
AIR COMPRESSOR SOP AnnexureXIII.docx (47.0 KB)
BOILER SOP AnnexureI.docx (45.6 KB)
AIR COMPRESSOR SOP AnnexureXIV.docx (45.6 KB)
AIR COMPRESSOR SOP.docx (77.4 KB)
BOILER SOP AnnexureII.docx (44.7 KB)
BOILER SOP.docx (73.3 KB)BREAKDOWN SOP AnnexureI.docx (45.3 KB)
BREAKDOWN SOP Annexure-III.docx (45.9 KB)
BREAKDOWN SOP.docx (68.1 KB)
CALIBRATION SOP Annexure1.docx (47.0 KB)
CALIBRATION SOP Annexure2.docx (47.6 KB)
CALIBRATION SOP Annexure3.docx (46.0 KB)
CALIBRATION SOP Annexure4.docx (47.0 KB)
CALIBRATION SOP Annexure5.docx (46.5 KB)
<a class=“attachment” href="/uploads/default/original/2X/1/198b2fde1344ff39bfbaCHILLING WATER SOP AnnexureI.docx (47.7 KB)
6ecfaaf9c577ea5c67c6.docx">CALIBRATION SOP Annexure6.docx (45.5 KB)
CALIBRATION SOP Annexure7.docx (46.4 KB)
CALIBRATION SOP Annexure8.docx (46.4 KB)
CALIBRATION SOP Annexure9.docx (24.6 KB)
CALIBRATION SOP Annexure10.docx (44.6 KB)
CALIBRATION SOP.docx (73.2 KB)
CHILLING WATER SOP AnnexureII.docx (44free chlorine purified water sop.docx (72.4 KB)
.7 KB)
CHILLING WATER SOP AnnexureIX.docx (45.2 KB)
CHILLING WATER SOP.docx (90.9 KB)HOT WATER GENRATION SOP AnnexureI.docx (45.2 KB)
HOT WATER GENRATION SOP.docx (63.6 KB)
HVAC sop AnnexureI.docx (42.5 KB)
<a class=“attachPreventive of FBD 1300 sop.docx (58.7 KB)
ment” href="/uploads/default/original/2X/0/0089404c0c21c81b3234e62973300b7e460c5773.docx">HVAC sop AnnexureII.docx (42.2 KB)
HVAC sop AnnexureIII.docx (41.4 KB)
HVAC sop.docx (68.4 KB)
Purified water system managemnet sop AnnexureI.docx (45.6 KB)
Purified water system managemnet sop AnnexureII.docx (42.9 KB)
Purified water system managemnet sop AnnexureIII.docx (43.5 KB)
Purified water system managemnet sop AnnexureIV.docx (43.3 KB)
Purified water system managemnet sop AnnexureIX.docx (43.7 KB)
Purified water system managemnet sop AnnexureV.docx (43.2 KB)
Purified water system managemnet sop AnnexureVI.docx (43.7 KB)
Purified water system managemnet sop AnnexureVII.docx (44.2 KB)
Purified water system managemnet sop AnnexureVIII.docx (43.1 KB)
Purified water system managemnet sop AnnexureX.docx (43.6 KB)
Purified water system managemnet sop AnnexureXI.docx (44.0 KB)
Purified water system managemnet sop AnnexureXII.docx (43.5 KB)
Purified water system managemnet sop AnnexureXIII.docx (43.2 KB)
Purified water system managemnet sop AnnexureXIV.docx (43.1 KB)
Purified water system managemnet sop AnnexureXV.docx (43.1 KB)
Purified water system managemnet sop.docx (153.4 KB)valiadation of HVAC,APU,LAF SOPAnnexure3.docx (42.0 KB)
valiadation of HVAC,APU,LAF SOP Annexure1.docx (45.2 KB)
valiadation of HVAC,APU,LAF SOP Annexure4.docx (45.4 KB)
valiadation of HVAC,APU,LAF SOP Annexure5.docx (32.1 KB)
<a class=“attachment” href="/uploads/default/original/2X/3/31c313070748cdb988d89eWater head storage tank sop Annexure1.docx (43.5 KB)
a6e88ea507108d9125.docx">valiadation of HVAC,APU,LAF SOP Annexure6.docx (26.1 KB)
valiadation of HVAC,APU,LAF SOP.docx (88.6 KB)
valiadation of HVAC,APU,LAF SOPAnnexure2.docx (44.8 KB)
Water head storage tank sop Annexure2.docx (42.5 KB)
water system managament sop AnnexureI.docx (42.7 KB)
Water head storage tank sop.docx (74.2 KB)
water system managament sop AnnexureII.docx (42.9 KB)
water system managament sop AnnexureIII.docx (42.1 KB)
water system managament sop AnnexureIV.docx (42.1 KB)
water system managament sop.docx (90.5 KB)


(YOGESH NARKHEDE) #80

cold storage sop AnnexureI.docx (29.0 KB)
cold storage sop AnnexureII.docx (42.6 KB)
cold storage sop AnnexureIII.docx (42.5 KB)
cold storage sop AnnexureIv.docx (43.5 KB)
cold storage sop Annexure–V.docx (42.7 KB)
Store LAF sop AnnexureI.docx (43.4 KB)
cold storage sop Annexure–VI.docx (42.7 KB)
cold storage sop.docx (76.1 KB)
Store LAF sop AnnexureII.docx (43.3 KB)
<a class=“attachment” href="/uploads/default/original/2X/0/097b7c7a54d493f58d1weighing balance sop AnnexureI.docx (42.5 KB)
705c53ff23eee1af3e5c5.docx">Store LAF sop AnnexureIII.docx (42.5 KB)
Store LAF sop AnnexureIV.docx (42.5 KB)
Store LAF sop AnnexureV.docx (42.3 KB)
Store LAF sop.docx (68.4 KB)
weighing balance sop.docx (72.1 KB)