No.

of SOP Pending in all Cross Functional Department

Sr.No. Department No.Old SOP Completed SOPs Old Pending SOPs Current Status No.of Effective Documents Remarks
1 QA 24 22 7 Under Preparation 22 NA
2 QC 18 17 12 Pending 17 NA
Pressure Monitoring and Temperature
3 PRODUCTION 28 23 2 NA 23 Monitoring Pending,,,,,Weighing Balance
Pending (3 SOP Merged)
4 Store 10 10 1 NA 10 Weighing Balance need too discuss
5 Engineering 4 4 NA NA 4 NA
6 HR 7 7 NA NA NA NA
 Outside Laboratory

Sr.No. Name of Outside Laboratory Questionnaire Sent Technical Agreement Sent Questionnaire Received Technical Agreement Received Remarks
1 Baroda Analytical Laboratory YES YES Pending Received NA
2 Uma Laboratory YES YES Pending Pending NA
 Service Contract Agency

Sr.No Name of Service Contract Questionnaire Sent Received Doc Remarks

1 Excellent Cooling Systems Yes Pending
2 N.R Balancers Yes Pending
3 Progen Consultancy Services Yes Pending
4 Samruddhi Trading Yes Pending
5 Shivam Home Appliances Sales and Service Yes Pending
6 Navrang Electronics Yes Pending
7 Stepson Solution Yes Pending
 Pending Vendor/Supplier

Sr.No. Trader /Supplier Name/Vendor Questionnaire Sent Questionnaire Received Remarks

1 PLANET SALES Yes Pending
2 GOLDCOIN PLASTIC (INDIA) Yes Pending
3 Karan Intermediates Pvt. Ltd Yes Pending
4 Trikaldashi Chemical Industries Yes Pending
5 Radhekrishna Corporation Yes Pending
6 BODAL  CHEMICALS LTD Yes Pending
7 Clairchem India Private Limited Yes Pending
8 Organix Yes Pending
9 VANDANA IMPEX Yes Pending
10 Sangram Industries Yes Pending
11 Prasol Chem Yes Pending
12 Dutt Traders Yes Pending
13 siddhivinayak Yes Pending
14 riteshchemicalindustries Yes Pending
15 Cleargreenspharma Yes Pending
16 sricpl Yes Pending
17 Krishna Enterprise Yes Pending
18 Gangotri Chemicals Yes Pending
19 cdppl Yes Pending
20 Crest Lifesciences Yes Pending
21 Usha Enterprise Yes Pending
 No.of Activity Pending on Plant and QC Level-2020

Batch Release
Production to Warehouse to data
Sr.No. Product Name Total no. of batches OK/NOT OK TR Slip QC Data (IP) QC Data (FP) Ware house Production (Checklist/CO Remarks BMR Completed Total
Slip slip A)-QA
Verification
17 Completed Ok Ok Pending Ok OK Ok NA
1 ALB-IV 34 8 Not ok Pending Total BMR 206
9 Running Pending AvailableCompleted BMR 69 69
2 DFA-I 16 Pending Pending Pending Pending Pending Pending Pending Available Sifting Packing BMR 32 62
3 DFA-II 15 Pending Pending Pending Pending Pending Pending Pending Available Milling BMR 10
4 DFA-III 17 5 ok 12 Pending 12 Pending Pending Pending Pending Pending Available Blending BMR 20
5 TNL 19 14 OK Ok Ok Pending Ok OK Ok NA Completed 131
6 FPS-I 11 Completed Ok Ok Pending Ok OK Ok
7 FPS-II 11 Completed Ok Ok Pending Ok OK Ok Pending 75
8 FPS-III 11 Completed Ok Ok Pending Ok OK Ok
9 VLD-I 2 Pending Pending Pending Pending Pending Pending Pending
10 VLD-II 2 Pending Pending Pending Pending Pending Pending Pending
11 Fluconazole 6 Pending Pending Pending Pending Pending Pending Pending
12 Blending 20 Completed Completed Completed Completed Completed Completed Completed NA
13 Milling 10 Completed Completed Completed Completed Completed Completed Completed NA
14 Shifting Packing 32 Completed Completed Completed Completed Completed Completed Completed NA

Total 206 5 TNL

17 Alb
16 DFA-I
15 DFA-II
12 DFA-III
2 VLD-I
2 VLD-II
6 FLU
75
 BMR Completed Total
No.of Activity Pending on Plant and QC Level-2019
Total BMR 206
AvailableCompleted BMR 69 69

QC Batch Dispatch
Available Sifting Packing BMR 32 62
Pending Activity Stage, Qty of Documents & A.R.No. Production Finished
Batch Production to WH Material Slip WH to Production Material Slip Inprocess Test/Finished Complete/
Sr.No. Product Name (QA/QC/Production/ Pending No.of Documents (A.R No. Generation A.R.No. Entry in Batch Record Product Pending Qty QA Review Pre-Dispatch Checklist/Finished Remarks
Record Pending Pending Product Pending
Store) (BMR) Completed/Not Completed) Completed/Not Completed Analysis Product Detail/Batch Release
(Analysis Slip) Detail/Release Checklist/COA
Available Milling BMR 10
1 DFA-I Total No.of Documents (BMR/Inprocess/Finished Product) 58 58 (32 Onwards) 26 (32 Onwards) 26 32 onwards all Pending (26) 32 onwards all Pending (26) TLC, LOD Pending Pending 58 Pending (26 TWS need to filled) 58 NA NA Available Blending BMR 20
2 DFA-II Total No.of Documents (BMR/Inprocess/Finished Product) 54 54 (39 onwards) 16 (39 onwardds) 16 54 54 TLC, LOD Pending Pending 54 54 NA NA Completed 131
3 DFA-III Total No.of Documents (BMR/Inprocess/Finished Product) 60 60 (40 onwards) 20 (40 onwards)20 60 60 LOD Pending Pending 60 60 Pending-60 NA
4 TNL Total No.of Documents (BMR/Inprocess/Finished Product) 27 27 (15 Onwards)12 (15 Onwards) 26 26 HPLC (BOC,Piperazine), LOD Pending Pending 26 26 Pending-26 NA Pending 75
5 Fluconazole Total No.of Documents (BMR/Inprocess/Finished Product) 23 23 Completed Completed TR Slip pending TR Slip pending HPLC, TLC, LOD,HPLC Pending Pending 23 23 Pending-23 NA
6 DEN-I Total No.of Documents (BMR/Inprocess/Finished Product) 4 4 3-Completed (4 no. PENDING) 3-Completed (4 no. PENDING) NA
7 DEN-II Total No.of Documents (BMR/Inprocess/Finished Product) 3 3 NA
8 DEN-III Total No.of Documents (BMR/Inprocess/Finished Product) 2 2 NA
9 VLD-I Total No.of Documents (BMR/Inprocess/Finished Product) 9 4 available(5,6,7,9) (5,6,7 Available (9no. Not available) (5,6,7 Available (9no. Not available) Pending Pending HPLC,HPLC,PH, LOD Pending Pending 9 9 Pending-9 NA
10 VLD-II Total No.of Documents (BMR/Inprocess/Finished Product) 9 4 Available (1,5,6,9) 1,5,6 Available (9 no. not available) 1,5,6 Available (9 no. not available) Pending Pending HPLC,HPLC,PH, LOD Pending Pending 9 9 Pending-9 NA
11 Blending Total No.of Documents (BMR/Inprocess/Finished Product) 5 5 NA NA NA NA NA NA NA 5 5 NA NA
12 Shifting and Packing Total No.of Documents (BMR/Inprocess/Finished Product) 5 5 NA NA NA NA NA NA NA 5 5 NA NA
13 Albendazole-I Total No.of Documents (BMR/Inprocess/Finished Product) 4 4 Pending Pending Pending Pending TLC, LOD Pending Pending 4 4 NA NA
14 Albendazole-II Total No.of Documents (BMR/Inprocess/Finished Product) 4 4 Pending Pending Pending Pending TLC Pending Pending 4 4 NA NA
15 Albendazole-III Total No.of Documents (BMR/Inprocess/Finished Product) 4 4 Pending Pending Pending Pending NA Pending Pending 4 4 NA NA
16 Albendazole-IV Total No.of Documents (BMR/Inprocess/Finished Product) 4 4 Pending Pending Pending Pending LOD Pending Pending 4 4 Pending-4 NA
17 FPS-I Total No.of Documents (BMR/Inprocess/Finished Product) 4 4 OK OK Pending Pending Moisture, SOR Pending Pending 4 4 Pending-4 NA
18 FPS-II Total No.of Documents (BMR/Inprocess/Finished Product) 4 4 OK OK Pending Pending PH, SOR Pending Pending 4 4 Pending-4 NA
19 FPS-III Total No.of Documents (BMR/Inprocess/Finished Product) 4 4 Pending Pending Pending Pending Moisture, PH, SOR Pending Pending 4 4 Pending-4 NA
20 4-HBA Total No.of Documents (BMR/Inprocess/Finished Product) 3 3
21 RSV-I Total No.of Documents (BMR/Inprocess/Finished Product) 1 Pending, Prod & QA Review Pending Pending Pending Pending Pending Pending Pending Pending Pending Pending Pending
22 Shifting and Packing Total No.of Documents (BMR/Inprocess/Finished Product) 1 Half Pending Pending Pending Pending Pending Pending Pending Pending Pending Pending Pending Pending

pr to WH wh to pr TR
105 105 105 Pending
Total BMR 292

OK 187
 No.of Activity Pending on Plant and QC Level-2018

Sr.No.Product NameNo.of Batches TR Slip Pr to WH WH to PR Release QA Review Production Review Remarks

1 DEN-I 2 NA Pending Pending Completed NA NA
2 DEN-II 2 NA Pending Pending Completed NA NA
3 DEN-III 2 NA Pending Pending Completed NA NA
4 DFA-I 36 36,35,34,33,32,31,30,29,28,27,25-NA 36,35,34,33,32,31,30,29,28,27,25-NA 36,35,34,33,32,31,30,29,28,27,25-NA Completed Completed Completed
5 DFA-II 31 29,30,31,28,27,26,25,23,22,20,19,18, 16,-NA 29,30,31,28,27,26,25,23,22,20,19,18, 16,-NA 29,30,31,28,27,26,25,23,22,20,19,18, 16,-NA Completed NA NA 30 & 31 Blank,24,21,not available
6 DFA-III 31 29,30,31,28,26,24,23,22,-NA 29,30,31,28,26,24,23,22,-NA 29,30,31,28,26,24,23,22,-NA Completed Completed Completed 30 & 31 Blank,27,25- NA
7 GFT-IV 5 Completed Completed Completed Completed Completed Completed
8 GFT-III 5 Completed Completed Completed Completed Completed Completed
9 GFT-II 5 Completed Completed Completed Completed Completed Completed
10 GFT-I 5 Completed Completed Completed Completed Completed Completed
11 RSV-I 1 Completed Completed Completed Completed Completed Completed
12 SMC-I 4 4-NA 4-NA 4-NA Completed Pending Pending
13 CMC 4 4-NA 4-NA 4-NA Completed Pending Pending
14 TMBA-II 5 5,4-NA 5,4-NA 5,4-NA Completed Pending Pending 5,4-Half Pending
15 TMBA-I 5 3,5-NA 3,5-NA 3,5-NA Completed Pending Pending 3,5-Half Pending
16 RSV-I 1 Completed Completed Completed Completed Completed Completed

11
BMR 144 15 48 Pending
10
4
4
2
2
 No.of Activity Pending on Plant and QC Level-2017

Sr.No. Product Name No.of Batches TR Slip Pr to WH WH to PR Release QA Review Production Review Remarks
1 TNL-1 6 Completed Completed Completed Completed Completed Completed
2 Sifting & Packing 6 Completed Completed Completed Completed Pending Completed
3 DFA-IV 16 16, 15,14-NA 16, 15,14-NA NA Completed 16, 15,14-NA Completed
4 Sifting & Packing 3 1,2,3 (13 pending) Completed Completed
5 GNT-I 1 Pending Pending Pending Completed Pending Completed
6 MTO-I 1 Completed Completed Completed Completed Completed Completed
7 MTO-II 4 Completed Completed Completed Completed Completed Completed
8 MTO-III 4 Completed Completed Completed Completed Completed Completed
9 DFA-III 9 5-Pending 5,6,7,8,9 pending 5,6,7,8,9 pending Completed Pending Pending
10 DFA-II 10 3-Pending 6,7,8 Pending 6,7,8 Pending Completed Pending Pending

Total 60 3 15 Pending
3
1
5
3
 No.of Activity Pending on Plant and QC Level-2016

Sr.NoProduct Name No.of Batches TR Slip Pr to WH WH to PR Release QA Review Production Review Remarks
1 AOE-I 5 Completed Completed Completed NA Completed Completed NA
2 AOE-II 5 Completed Completed Completed NA Completed Completed NA
3 GPL-I 3 Completed Completed Completed NA Pending-3 Completed NA
4 CTC-II 2 Completed Completed Completed NA Completed Completed NA
5 NEH-I 1 Completed Completed Completed NA Completed Completed NA
6 NEH-II 1 Completed Completed Completed NA Completed Completed NA
7 MTO-III 5 Completed Completed Completed NA Completed Completed NA
8 MTO-II 6 Completed Completed Completed NA Completed Completed NA
9 MTO-I 7 Completed Completed Completed NA 7-Pending Completed NA
10 DFA-II 19 Completed Completed Completed NA 19,18,17,16,15,14,13,12,11.10,9,8,7,6,5,4,3,2,1 Completed NA
11 DFA-I 8 Completed Completed Completed NA 8,7,6,5,4,3,2,1 Completed NA
12

Total 62
19 36 Pending
7
3
7
 RM Pending Chemicals Inprocess Chemicals

Sr.No. Chemical Name Remarks Sr.No. Chemical Name Remarks

Trimethyl sulfoxonium Iodide
1 Ammonium Thiocynate
2 Ammonium Ferric Sulphate solution
3 Carbon Tetra Chloride
4 Iodine Monochloride
1 Salicylic Acid Working Standard
2 sodium dihydrogen Phosphate monohydrate
3 Phosphorus Acid
indicator

DFTA
5 ammonium acetate Total 2 IP
6 Tetra Methyl Ammonim Bromide
7 Glacial Acetic Acid

Anisole
8 Anisole, Merck GC-Grade
Caustic Soda Flakes/Sodium Hydroxide
9 Potassium Carbonate
10 Potassium Pyroantimonate
Hydrochloric Acid
11 Methyl Red Indicator
12 Citric Acid
13 Thioglycolic acid
14 25% Ammonia
Salicylic Acid
15 Acetone AR Grade
16 Ethanol AR Grade
17 Phenol Red Indicator
18 Phosphorus Pentoxide
4-HBA
19 Sodium Hydroxide
20 Thymol Blue indicator
Total 20 RM
 Intermediate Chemicals Finished Chemicals

Sr.No. Chemical Name Remarks Sr.No. Chemical Name Remarks

1 phosphoric acid 1 Glycerine
2 Potassium Phosphate Monobasic 2 Fluconazole Related Compound A,B,C
3 sodium perchlorate 3 Deferasirox
4 2-aminothiozole-4-yl-acetic acid (ATTA) 4
5 Potassium Bromide 5
6 N-Acetylcytosine Standard 6
7 6N Ammoniium hydroxide 7
8 Lead Nitrate 8
9 Thioacetamide 9
10 Thioacetamide glycerine 10
11 0.22µm nylon membrane filters,47 nm diameter 11
12 Diammonium Hydrogen Phosphate 12
13 Eosin Yellowish indicator 13
14 Benzyl Alcohol 14
15 n-Heptane
16 1,2-dichloroethane

Total 16 IM
 PENDING SPECIFICATION & MOA

RM
RM/PM/IP/
Effective Review Effective Review
Sr.No. IM/FP Name of Material Specification MOA Remarks
Date Date Date Date
CODE
2,3-Dichloro-5,6-dicyano-1,4-benzoquinone
1 RM00001 Total Raw Material 287
(DDQ)
2 RM00002 7-Methoxy-1-tetrolone Available RM Spec 91
3 RM00003 Activated Carbon SPEC/RM/RM00003/01 28/11/2019 Oct-22 STP/RM/RM00003/01 28/11/2019 Oct-22 Available RM MOA 27
4 RM00004 Aluminium Chloride SPEC/RM/RM00004/01 26/11/2019 Oct-22 NA Pending Spec 234
5 RM00005 Anisole SPEC/RM/RM00005/01 26/11/2019 Oct-22 STP/RM/RM00005/01 26/11/2019 Oct-22 Pending MOA 260
6 RM00006 Benzyl Amine
7 RM00007 Benzyl Trimethyl Ammonium Chloride
8 RM00008 Sodium Hydroxide / Caustic soda Flakes SPEC/RM/RM00008/01 28/11/2019 Oct-22 STP/RM/RM00008/01 28/11/2019 Oct-22 SPEC/RM/RM00008/01 16/11/201Sept-22 STP/RM/RM00008/01 16/11/201 Sept-22 NV
9 RM00009 Cyanoacetic Acid 95%
10 RM00010 Cyclohexane
11 RM00011 Di Potassium Phosphate
12 RM00012 Diatomite Super Cell (Hyflow) SPEC/RM/RM00012/01 28/11/2019 Oct-22 STP/RM/RM00012/01 28/11/2019 Oct-22
13 RM00013 Heptanoic Acid
14 RM00014 Hydrochloric Acid - CP SPEC/RM/RM00014/01 28/11/2019 Oct-22 STP/RM/RM00014/01 28/11/2019 Oct-22 NV-16/11/19, SEPT-22
15 RM00015 Hydrogen Peroxide-50%
16 RM00016 Iso Propyl Alcohol - IPA SPEC/RM/RM00016/00 31/12/2019 31/12/22 STP/RM/RM00016/00 31/12/2019 31/12/22
17 RM00017 Methanol SPEC/RM/RM00017/00 31/12/2019 31/12/22 STP/RM/RM00017/00 31/12/2019 31/12/22
18 RM00018 Methyl Mono Chloro Acetate (MMCA)
19 RM00019 Methylene Dichloride SPEC/RM/RM00019/01 29/06/2019 May-22 STP/RM/RM00019/01 29/06/2019 May-22
20 RM00020 Mix Solvent
21 RM00021 Para Anisic Aldehyde
22 RM00022 Petroleum Ether
23 RM00023 Phthalimide
24 RM00024 Potassium Carbonate SPEC/RM/RM00024/00 16/10/2019 Sep-22 STP/RM/RM00024/00 16/10/2019 Sep-22
25 RM00025 Epichlorohydrine
26 RM00026 Sodium Bi Carbonate SPEC/RM/RM00026/01 28/11/2019 Oct-22 STP/RM/RM00026/01 28/11/2019 Oct-22
27 RM00027 Sodium Bisulphite
28 RM00028 Sodium Chloride SPEC/RM/RM00028/00 31/12/2019 31/12/22 STP/RM/RM00028/00 31/12/2019 31/12/22
29 RM00029 Sodium Metal
30 RM00030 Sodium Nitrite
31 RM00031 Sodium Sulphate SPEC/RM/RM00031/00 31/12/2019 31/12/22 STP/RM/RM00031/00 31/12/2019 31/12/22
32 RM00032 Succinic Anhydride SPEC/RM/RM00032/01 25/11/2019 Oct-22 NA
33 RM00033 Sulphuric Acid -AR Grade SPEC/RM/RM00033/01 26/11/2019 Oct-22 STP/RM/RM00033/01 26/11/2019 Oct-22
34 RM00034 Thionyl Chloride SPEC/RM/RM00034/01 26/11/2019 Oct-22 NA
35 RM00035 Toluene SPEC/RM/RM00035/01 26/11/2019 Oct-22 STP/RM/RM00035/01 26/11/2019 Oct-22
36 RM00036 Tri Sodium Phosphate
37 RM00037 Zinc Dust SPEC/RM/RM00037/01 25/11/2019 Oct-22 NA
38 RM00038 Ammonia Solution 25%
39 RM00039 Benzyl Chloride
40 RM00040 n-Hexane
41 RM00041 Ethyl Acetate SPEC/RM/RM00041/01 28/11/2019 Oct-22 STP/RM/RM00041/01 28/11/2019 Oct-22 2(NV-16/11/19, SEPT-22)
42 RM00042 Cyanoacetic Acid
43 RM00043 Dimethyl Formamide SPEC/RM/RM00043/01 28/11/2019 Oct-22 STP/RM/RM00043/01 28/11/2019 Oct-22
44 RM00044 Acetic Acid
45 RM00045 Hydro bromic Acid 48% SPEC/RM/RM00045/00 31/12/2019 31/12/22 STP/RM/RM00045/00 31/12/2019 31/12/22
46 RM00046 Sulphuric acid
47 RM00047 Nitric acid
48 RM00048 Phenyl ethyl amine
49 RM00049 Diethyl ester
50 RM00050 Hydrofluoric acid
51 RM00051 Sodium Meta Bisulphate
52 RM00052 TETRA HYDRO FURAN
53 RM00053 Ice
54 RM00054 MAGNESIUM TURNING
55 RM00055 Pyridine Hydrochloride SPEC/RM/RM00055/01 29/11/2019 Oct-22 NA
56 RM00056 Deferasirox Technical
57 RM00057 2-Phenylethylamine
58 RM00058 Dry HCL Gas
59 RM00059 2,5-Diclorothiophene
60 RM00060 SILICA GEL-BLUE
61 RM00061 Benzyl Cyanide
62 RM00062 Acetone solvent
63 RM00063 TNL-01 (KSM-1) SPEC/RM/RM00063/00 31/12/2019 31/12/22 STP/RM/RM00063/00 31/12/2019 31/12/22
64 RM00064 Sodamide
65 RM00065 TNL-02 (KSM-2) SPEC/RM/RM00065/00 31/12/2019 31/12/22 STP/RM/RM00065/00 31/12/2019 31/12/22
66 RM00066 TNL-03 SPEC/RM/RM00066/00 31/12/2019 31/12/22 STP/RM/RM00066/00 31/12/2019 31/12/22
67 RM00067 Thiophene
68 RM00068 S-(+)-Epichlorohydrin
69 RM00069 CO2 Gas
70 RM00070 2-Amino Thiophenol
71 RM00071 Iodine IP
72 RM00072 Bromine
73 RM00073 Liqour Ammonia
74 RM00074 Acetyl Chloride
75 RM00075 Caustic Lye
76 RM00076 RSV-01
77 RM00077 Pyridine SPEC/RM/RM00077/00 31/12/2019 31/12/22 STP/RM/RM00077/00 31/12/2019 31/12/22
78 RM00078 RLX-01
79 RM00079 RLX-02 SPEC/RM/RM00079/00 31/12/2019 31/12/22 NA
80 RM00080 IVR-01 SPEC/RM/RM00080/00 31/12/2019 31/12/22 NA
81 RM00081 ATA-01 SPEC/RM/RM00081/00 31/12/2019 31/12/22 NA
82 RM00082 Ethylbromoacetate
83 RM00083 IVR-02
84 RM00084 Acetonitrile
85 RM00085 Mono Methyl Amine SPEC/RM/RM00085/00 31/12/2019 31/12/22 NA
86 RM00086 Phosphoric Acid
87 RM00087 Salicylic Acid SPEC/RM/RM00087/01 25/11/2019 Oct-22 STP/RM/RM00087/01 25/11/2019 Oct-22
88 RM00088 Salicylamide NF SPEC/RM/RM00088/01 25/11/2019 Oct-22 STP/RM/RM00088/01 25/11/2019 Oct-22
 89 RM00089 4-Hydrazino Benzoic Acid SPEC/RM/RM00089/01 25/11/2019 Oct-22 STP/RM/RM00089/01 25/11/2019 Oct-22
90 RM00090 EDTA
91 RM00091 NAC-01 SPEC/RM/RM00091/00 31/12/2019 31/12/22 NA
92 RM00092 Triethylamine SPEC/RM/RM00092/00 31/12/2019 31/12/22 NA
93 RM00093 Sodium Acetate
94 RM00094 Thiourea
95 RM00095 Potassium Hydroxide SPEC/RM/RM00095/01 30/11/2019 Oct-22 STP/RM/RM00095/01 30/11/2019 Oct-22
96 RM00096 Poly Phosphoric acid
97 RM00097 1-bromo-3-chloropropane SPEC/RM/RM00097/01 31/01/2020 Dec-22 NA
98 RM00098 Calcium Chloride Dihydrate
99 RM00099 L-Cystine
100 RM00100 Tert butyl thiol
101 RM00101 Methyl tert-butyl ether
102 RM00102 Methane Sulphonic Acid
103 RM00103 Sodium Methoxide solution
104 RM00104 L-Lysine
105 RM00105 Ammonia Solution (22%-27%)
106 RM00106 Para Toluene Sulphonic Acid
107 RM00107 Hydroxylamine sulphate
108 RM00108 4-Chloro benzoic acid
109 RM00109 Methyl Indole
110 RM00110 Hydroxylamine O Sulfonic Acid
111 RM00111 MNT-01
112 RM00112 Chloro Sulphonic Acid SPEC/RM/RM00112/00 03/10/2017 Sept-20 NA
113 RM00113 Methyl-5-chloro2-methoxybenzoate
114 RM00114 Beta phenyl ethyl amine
115 RM00115 Sodium Methoxide
116 RM00116 Ethylene Dichloride
117 RM00117 Cyclohexyl Isocyanate
118 RM00118 Potassium tert butoxide
119 RM00119 Formaldehyde
120 RM00120 2-Amino-3,5-dibromobenzaldehyde
121 RM00121 Trans-4-Aminocyclohexanol
122 RM00122 Sodium borohydride
123 RM00123 Naphthalene SPEC/RM/RM00123/00 03/10/2017 Sept-20 NA
124 RM00124 Nitrobenzene SPEC/RM/RM00124/00 03/10/2017 Sept-20 NA
125 RM00125 Dimethyl sulfoxide SPEC/RM/RM00125/00 03/10/2017 Sept-20 NA
126 RM00126 7-Methoxy-1-Naphthylacetonitrile S/RM00126-01 15/06/2020 15/06/2023NA
127 RM00127 Diethyl(hydroxymethyl) phosphonate SPEC/RM/RM00127/00 03/10/2017 Sept-20 NA
128 RM00128 Diatomite Supper Cell
129 RM00129 JOB WORKS
3-(  purity -3 [P-METHOXYBENZYL ] -1-2
130 RM00130
DIHYDROQUI
131 RM00131 Phenol Crystals 99.5% Purity AR
132 RM00132 Powder Cellulose
133 RM00133 Sodium Monochloro Acetate

134 RM00134 2,4-Difluro-2- ( 1 h -1,2,4-triazd -1-yl) acetoph SPEC/RM/RM00134/00 31/12/2019 31/12/2022NA

135 RM00135 1,2,4-Triazole SPEC/RM/RM00135/00 31/12/2019 31/12/2022STP/RM/RM00135/00 31/12/2019 31/12/2022
136 RM00136 Trimethyl Sulfoxonium Iodide SPEC/RM/RM00136/00 31/12/2019 31/12/2022STP/RM/RM00136/00 31/12/2019 31/12/2022
137 RM00137 Citric Acid SPEC/RM/RM00137/00 31/12/2019 31/12/2022STP/RM/RM00137/00 31/12/2019 31/12/2022
138 RM00138 Cellulose Powder
139 RM00139 Sodium Monochoroacetate
140 RM00140 80% Aqueous Methanol
141 RM00141 35.5% Aqueaus HCL
142 RM00142 Calcium Carbonate
143 RM00143 Aqueous IPA (87%)
144 RM00144 Aqueous Methanol (70%)
145 RM00145 Sodium Hyprocaloride
146 RM00146 Isovanilin
147 RM00147 Sodium formate
148 RM00148 Morpholine
149 RM00149 Sodium Hydro Sulphite(Dithionate)
150 RM00150 Activated Crabon (make norit)
151 RM00151 Formic Acid
152 RM00152 N Butanol
153 RM00153 N,N Dimethyl formamide (Dimethyl Acetal)
154 RM00154 3 Acetyle Pyridine
155 RM00155 Ferric Chloride
156 RM00156 Hydrazine Hydrate
157 RM00157 Activated Charcol
158 RM00158 4 Bromomethyl Benzonitrile
159 RM00159 N Methyl Piperazine
160 RM00160 Chloroform
161 RM00161 1-(2-methyl-5-nitrophenyl)guanidine
162 RM00162 Acticarbone ENO-Pc
163 RM00163 Salt
164 RM00164 Anhydrous Sodium Sulphate
4-[(4-Methylpiperazin-1-Yl)Methyl] Benzoic
165 RM00165
Acid
166 RM00166 Ethylene Dichloride Rec(EDC)
167 RM00167 2-Tetrahydro Furoic Acid
168 RM00168 Magnesium sulphate
169 RM00169 s(-)-A-Methyl Benzyl amine
Purified Rec .S(-)-A-Methyl Amine From
170 RM00170
Stage-I
171 RM00171 Methanol for clearing
172 RM00172 MDC For Clearing
173 RM00173 Nitrogen Gas Cylinder-
174 RM00174 Faro Penel Stage -I
175 RM00175 Frka Stage-I
176 RM00176 Methylene Di-chloride (Fresh)
177 RM00177 Methylene Di chloride (Rec)
178 RM00178 Ethyle Acetate (fresh)
179 RM00179 Ethyle Acetate (Rec)
180 RM00180 Hyflow supercel
181 RM00181 Faro Penem St-II
182 RM00182 Rec Tetrahydrofuran From Stage III
Purified Rec .S(-)-A-Methyl Amine From
183 RM00183
Stage-II
184 RM00184 Sodium Hydrosulfide Hydrate
185 RM00185 Gallic Acid
186 RM00186 Ethylene DI Chloride (Recovered)
187 RM00187 Scrap Materials
188 RM00188 Scrap Materils -
189 RM00189 Potassium Permanganate
190 RM00190 Sodium Carbonate
191 RM00191 Phosphorus Oxychloride(pocl 3)
192 RM00192 DI METHYL SULPHATE
193 RM00193 Calcium Acetate Hydrate
194 RM00194 MMA Solution
195 RM00195 Mono Methyl Amine Gas
196 RM00196 Chloromethyl Naphthalene( CMN)
197 RM00197 Methanol for Solution -NMH-I
198 RM00198 Calcium Acetate
199 RM00199 2,3,4,5-Tetramethyl-2-cyclopentenone
S-3-Aminomethyl -5-Methyl Hexanoic
200 RM00200
Acide( Crude)
201 RM00201 R1
202 RM00202 Propionic Anhydride
203 RM00203 Meta Bromo Anisol
Methyl Magnesium Chloride 3 Molar Solution
204 RM00204
In THF
205 RM00205 5-(4-Chlorobutyl)-1-Cyclohexyl-1H-Tetrazole
206 RM00206 6-Hydroxy-3,4-Di-Hydro-Quinoline-2-(1H)-One
207 RM00207 Hydrogenation Of Gallic Acid
208 RM00208 Hexane
209 RM00209 1 H 1.2.4 Triazole
2 4-Difluoro -Alpha-(1H-1 2 4-
210 RM00210
Triaziole)Acetoph
211 RM00211 Tmsi Solution
212 RM00212 1,3,Difluoro Benzene
213 RM00213 Cyanuric Choride
214 RM00214 4 Amino 1,2,4 Triazole
215 RM00215 Hexahydrophthalic Anhydride (HHPA)
216 RM00216 2-Methoxy -4-Amino-5-Fluropyrimidine
217 RM00217 Tri Methyl Sulphoxonium Iodide
218 RM00218 Rosuvastatin Calcium IP
219 RM00219 DEFERASIROX IH
220 RM00220 FLUCONAZOLE USP
221 RM00221 VILDAGLIPTIN IH
222 RM00222 Sodium Nitrate
223 RM00223 Phenol
224 RM00224 M.Chlorobenbandehye
225 RM00225 Benzyl Benzoate
226 RM00226 Metaphenoxy Benzaldehyde
227 RM00227 Teneligliptin Hydrobromic Hydrate
228 RM00228 GLIMEPIRIDE IP
229 RM00229 AMIODARONE HYDROCHLORIDE
230 RM00230 Para Aminobenzoic Acid
231 RM00231 Sodium Hydrogen Sulphide
232 RM00232 AMMONIUM THIOCYANATE 99% MIN
233 RM00233 N Propyl Bromide
234 RM00234 Methyl Chloro Formate (MCF)
235 RM00235 Indene
236 RM00236 Di methyl amine hydrochloride
237 RM00237 KBP
238 RM00238 2-Nitro aniline
239 RM00239 N-Propyl Alcohol
240 RM00240 TETRABUTYL AMMONIUM BROMIDE
241 RM00241 3-AMINO-1-ADAMANTANOL
242 RM00242 Aq.AMMONIA SOLUTION
243 RM00243 Dichloromethane
244 RM00244 L-PROLINAMIDE
245 RM00245 CHLORO ACETYL CHLORIDE
246 RM00246 Hydrogen Cynamide 50%
GLYCINEETHYLESTER HCL>99%
247 RM00247 SPEC/RM/RM00247/00 16/10/2019 Sep-22 STP/RM/RM00247/00 16/10/2019 Sep-22 NV
SPECTROCHEM
N-METHYLMORPHOLINE 98%
248 RM00248
SPECTROCHEM.
249 RM00249 ALBENDAZOLE IP
(2S)-4-OXO-2-(3-
250 RM00250
THIAZOLIDINYLCARBONYL)(KSM-1)
1-(3-METHYL-1-PHENYL-1H-PYRAZOL-5-
251 RM00251
YL) (KSM-2)
252 RM00252 AQUEOUS HYDROBROMIC ACID
253 RM00253 Crude Diamine
254 RM00254 Piperazine Dihydrochloride salt
255 RM00255 Glycocholic Acid Crude
256 RM00256 Olmesartan Medoxomil
257 RM00257 ORTHO NITRO ANILINE
258 RM00258 Telmisartan Ip
259 RM00259 5-Chloro Thiophene-2-Carboxylic Acid
260 RM00260 Chorlic Acid
261 RM00261 Telmisartan Usp
262 RM00262 Telmisartan Ep
263 RM00263 CDMT SPEC/RM/RM00263/00 16/10/2019 Sep-22 STP/RM/RM00263/00 16/10/2019 Sep-22 NV
264 RM00264 Dmtmmc
265 RM00265 SERTRACONAZOLE NITRATE BP
266 RM00266 Hi Flow Filteraid
267 RM00267 2 Amino -5-Nitrothiazole
268 RM00268 2-Methyl-2-Propanethiol
269 RM00269 Anhydrous Hcl (Ahcl)
270 RM00270 Solvent
271 RM00271 Telmisartan JP
272 RM00272 Diamine
methyl N-(6-propylsulfanyl-1H-benzimidazol-
273 RM00273
2-yl)ce
274 RM00274 FLUCONAZOLE IP
275 RM00275 ALBENDAZOLE USP
276 RM00276 Sodium Hypochlorite sol
277 RM00277 Phenomenal Emulsion
278 RM00278 Linezolid
279 RM00279 Lulicanazole
280 RM00280 4-Methylmorpholine SPEC/RM/RM00280/00 16/10/2019 Sep-22 STP/RM/RM00280/00 16/10/2019 Sep-22 NV
281 RM00281 Dysole
282 RM00282 Cholic acid SPEC/RM/RM00282/00 16/10/2019 Sep-22 STP/RM/RM00282/00 16/10/2019 Sep-22 NV
283 RM00283 Tetrahydrofuran lot 1 SPEC/RM/RM00283/00 16/10/2019 Sep-22 STP/RM/RM00283/00 16/10/2019 Sep-22 NV
284 RM00284 Tetrahydrofuran lot 2
285 RM00285 Etoricoxib
sodium;(5R,6S)-6-[(1R)-1-hydroxyethyl]-7-
286 RM00286
oxo-3-[(e
287 RM00287 2- Acetyle Pyridine
 PENDING SPECIFICATION & MOA

Effective Review Effective Review IM

Sr.No. RM/PM/IP/IM/FP CODE Name of Material Specification Date Date MOA Date Date Remarks
1 IM00001 MTO-I SPEC/IM/MTO-I/01 27/11/2019 Oct-22
2 IM00002 MTO-II SPEC/IM/MTO-II/01 27/11/2019 Oct-22 Total Intermediate 98
3 IM00003 MTO-III SPEC/IM/MTO-III/01 27/11/2019 Oct-22 Available IM Spec 9
4 IM00004 AOE- I SPEC/IM/AOE-I/01 26/11/2019 Oct-22 Available IM MOA 5
5 IM00006 DFA-III Pending Spec 89
6 IM00007 Recoverd MDC DFA-III Pending MOA 93
7 IM00008 Reocoverd Methanol DFA-IV SPEC/IM/IM00008/02 27/01/20 DEC-22
8 IM00009 Distilled MDC DFA-III
9 IM00010 Distilled Methanol DFA-IV
10 IM00011 CF ML (Washing) MTO-I
11 IM00012 2-(4-Nitropheneyl) ethylamine HCL
12 IM00013 Recovered MDC MTO-III
13 IM00014 Distilled MDC MTO-III
14 IM00015 Distilled Toluene MTO-III
15 IM00016 Distilled Toluene AOE-I
16 IM00017 Distilled MDC AOE-II
17 IM00018 Distilled Toluene AOE-II
18 IM00019 CF ML Isopropyl Alcohol AOE-II
19 IM00020 DFA-I SPEC/IM/DFA-I/01 29/01/2020 Dec-22 STP/IM/DFA-I/01 29/01/2020 Dec-22
20 IM00021 DFA-II SPEC/IM/DFA-II/01 29/01/2020 Dec-22 STP/IM/DFA-II/01 29/01/2020 Dec-22
21 IM00022 Distilled CF ML Methanol DFA-IV
22 IM00023 Distilled MDC MTO-II
23 IM00024 Recovered Toluene MTO-II
24 IM00025 DFA-IV
25 IM00026 CF ML IPA TNL-I
26 IM00027 Distilled Toluene TNL-I
27 IM00028 MLA-I
28 IM00029 Distilled Toluene MLA-I
29 IM00030 AOE-II SPEC/IM/AOE-II/01 28/11/2019 Oct-2022 STP/IM/AOE-II/01 28/11/2019 Oct-2022
30 IM00031 TNL-I SPEC/IM/TNL-I/01 08/02/2017 Jan-20 STP/IM/TNL-I/01 08/02/2017 Jan-20
31 IM00032 CTC-II
32 IM00033 Distilled Ethyl Acetate CTC-II
33 IM00034 Distilled Tetrahydrofuran CTC-II
34 IM00035 Organic Layer MDC DFA-III
35 IM00036 NEH-I SPEC/IM/NEH-I/01 30/11/2019 Oct-22 STP/IM/NEH-I/01 30/11/2019 Oct-22
36 IM00037 NEH-II
37 IM00038 CF ML Toluene NEH-I
38 IM00039 CF ML Methanol NEH-II
39 IM00040 GPL-I
40 IM00041 Recoverd Toluene MTO-III
41 IM00042 Recovered MDC MTO-II
42 IM00043 Distilled Toluene MTO-II
43 IM00044 Recovered Toluene AOE-I
44 IM00045 Recovered Toluene AOE-II
45 IM00046 Recovered MDC AOE-II
46 IM00047 Toluene-Methanol Mixture DFA-I
47 IM00048 Distilled MDC DFA-I
48 IM00049 Recovered Methanol DFA-II
49 IM00050 Recovered Toluene DFA-II
50 IM00051 Distilled Methanol DFA-III
51 IM00052 Distilled MDC GPL-I
52 IM00053 AOE(B)-II
53 IM00054 CF ML Methanol DFA-I
54 IM00055 CF ML Toluene DFA-II
55 IM00056 CIS-I
56 IM00057 CIS-II
57 IM00058 CIS-III
58 IM00059 CIS-III(A)
59 IM00060 CIS-III(B)
60 IM00061 CIS-IV
61 IM00062 CF ML Toluene CIS-II
62 IM00063 Recovered Toluene CIS-II
63 IM00064 D-Complex ML
64 IM00065 D(+) Acid ML
65 IM00066 CF ML Methanol CIS-III(A)
66 IM00067 Recovered Methanol CIS-III
67 IM00068 Recovered L-Lysine
68 IM00069 CF ML Toluene CIS-IV
69 IM00070 CF ML Methanol CIS-IV
70 IM00071 Recovered Toluene CIS-IV
71 IM00072 Recovered Methanol CIS-IV
72 IM00073 Ketosulfone
73 IM00074 CDTH Phosphate salt
74 IM00075 GLB-II
75 IM00076 GLB-III
76 IM00077 GLB-IV
77 IM00078 AMB-I
78 IM00079 AMB-II
79 IM00080 Sodium Carboxy Methyl Cellulose
80 IM00081 PAC-III
81 IM00082 GFT-I
82 IM00083 GFT-II
83 IM00084 GFT-III
84 IM00085 FPS-I
85 IM00086 Recovered Toluene for NMH-I
86 IM00087 TMB-I
87 IM00088 Recovered Methanol RSV-I
88 IM00089 Recovered Toluene for RSV-I
89 IM00090 RSV-I
90 IM00091 MPN-I
91 IM00092 FLY
92 IM00093 ALB-I
93 IM00094 ALB-II
94 IM00095 ALB-III
95 IM00096 ALB-IV
96 IM00097 FPS-II
GLYCOCHOLIC ACID
97 IM00098 (Kunishima Reagent)
98 IM00099 GLYCOCHOLIC ACID (CRUDE)-

AVAILABLE without IM CODE

1 SPEC/IM/RLX/00 31/12/19 31/12/22 NA

2 SPEC/IM/DEN-II/00 03/10/17 Sept-20 STP/IM/DEN-II/00 03/10/17 Sept-20
3 SPEC/IM/DEN-I/00 03/10/17 Sept-20 STP/IM/DEN-I/00 03/10/17 Sept-20
4 SPEC/IM/AOE(A)-VI/0127/11/19 Oct-22 STP/IM/AOE(A)-VI/01 27/11/19 Oct-22
5 SPEC/IM/NAC-I/01 27/11/19 Oct-22 STP/IM/NAC-I/01 27/11/19 Oct-22
6 SPEC/IM/VLD-I/00 26/08/19 Jul-22 na
7 NA STP/IM/VLD-II/00 26/08/19 Jul-22
8 SPEC/IM/CLM-I/00 12/09/2019 Aug-22 STP/IM/CLM-I/00 12/9/2019 Aug-22
9 SPEC/IM/DAC-III/00 12/09/2019 Aug-22 STP/IM/DAC-III/00 12/9/2019 Aug-22
10 SPEC/IM/HTO-I/01 27/01/2020 Dec-22 NA
11 SPEC/IM/IVR-III/01 31/12/19 Nov-22 NA
12 SPEC/IM/ATA-III/01 31/12/19 Nov-22 STP/IM/ATA-III/01 31/12/19 Nov-22
13 SPEC/IM/RLX-IV/01 20/12/19 Nov-22
 PENDING SPECIFICATION & MOA

RM/PM/I
P/IM/FP Effective Review Effective Review IM
Sr.No. CODE Name of Material Specification Date Date MOA Date Date Remarks
1 FG00001 ACETONE
2 FG00002 AOE Total Finished Product 26
3 FG00004 2-[(2S)-OXIRAN-2-YLMETHYL]-1HISOINDOLE-1,3-(2H)-DO SPEC/FG/GPL/01 29/11/19 Oct-22 NA Available FP Spec 6
4 FG00005 3-Acetyl-2.5 dichlorothiophene, 98% Available FP MOA 4
03/10/17.28/0 Sept- Sept-20,Dec-
5 FG00006 DFA SPEC/FG/DFA/00 1/20 20,Dec-22 STP/FG/IH/DFA/00 03/10/17.28/01/ 22 Pending Spec 20
6 FG00007 MLA (CAS-63106-93-4) SPEC/FG/MLA/00 02/01/17 Jan-20 STP/FG/MLA/00 25/03/17 Feb-20 Pending MOA 22
7 FG00008 TNL SPEC/FG/TNL-I/01 28/01/20 Dec-22 STP/FG/TNL-I/01 28/01/20 Dec-22
8 FG00009 STB
9 FG00010 2-Methyl Indoline
10 FG00011 {(2S,4S)-[3-Methyl-1-phenyl-1-H-pyrazol-5-yl)pipea
11 FG00012 DEN-III SPEC/FG/DEN/00 03/10/17 Sept-20 STP/FG/DEN/00 03/10/17 Sept-20
12 FG00013 2-Amino-3(4-methoxyphenyl)-2-methylamide
13 FG00014 7-methoxy-1-naphthyl acetonitrile
14 FG00015 4-Methyl-N3-[4-(3-pyridinyl)-2-pyrimidinyl]-1,3-be
15 FG00016 4-(4-Methyl piperizinom methyl)benzoyl chloride
16 FG00017 CMN Stage -I
17 FG00018 GFT-IV
18 FG00019 2-(2-Acetoxy) Benzamido-5-Nithrothiazole
19 FG00020 Sulfonyl Chloride 4c
20 FG00021 TMB-II
21 FG00022 CLS
22 FG00023 PEN
23 FG00024 FLU-I SPEC/FG/FLU/00 07/06/17 May-20 STP/FG/FLU/00 07/06/17 May-20
24 FG00025 GLYCOCHOLIC ACID (PURE)
25 FG00026 SGL (SODIUM GLYCOCHOLATE)-

AVAILABLE without FG CODE

Sr.No. RM/PM/IPName of Material Specification Effective DReview Da

MOA Effective DReview DaRemarks
1 5-CHLOROTHIOPHENE-2-CARBOXILIC ACID SPEC/FG/CTC/01 29/11/19 Oct-22 STP/FG/CTC/01 29/11/19 Oct-22
2 4-Hydrazino benzoic acid SPEC/FG/4HBA/01 27/11/19 Oct-22 STP/FG/4HBA/01 27/11/19 Oct-22
3 N-Acetylcytosine SPEC/FG/NAC/01 29/11/19 Oct-22 STP/FG/NAC/01 29/11/19 Oct-22
4 Pregablin SPEC/FG/IH/PAC/01 27/01/20 Dec-22 STP/FG/IH/PAC/01 01/06/17 May-20
5 SPEC/FG/NEH/02 02/03/20 02/03/23 STP/FG/NEH/01 02/03/20 02/03/23
6 Montelukast sodium SPEC/FG/MNT/01 31/01/20 Dec-22 NA
7 Montelukast sodium SPEC/FG/USP/MNT/00 23/02/20 Jan-22 STP/FG/USP/MNT/0023/02/20 Jan-22
8 Montelukast sodium SPEC/FG/IP/MNT/00 22/02/19 Jan-22 STP/FG/IP/MNT/00 22/02/19 Jan-22
9 SPEC/FG/IH/MLA/01 31/01/20 Dec-22 NA
10 Rosuvastatin Calcium SPEC/FG/IH/RSV/01 28/02/20 Jan-23 STP/FG/IH/RSV/01 28/02/20 Jan-23
11 Rosuvastatin Calcium SPEC/FG/IP/RSV/00 25/02/19 Jan-22 STP/FG/IP/RSV/00 25/02/19 Jan-22
12 Rosuvastatin Calcium SPEC/FG/EP/RSV/00 17/09/20 Jan-22 na
13 SPEC/FG/IH/AMB/00 01/06/17 May-20 STP/FG/IH/AMB/00 01/06/17 May-20
14 SPEC/FG/AMB/00 01/06/17 May-20 STP/FG/AMB/00 01/06/17 May-20 2
15 SPEC/FG/IP/AMB/00 22/02/19 Jan-22 STP/FG/IP/AMB/00 22/02/19 Jan-22
16 SPEC/FG/BP/AMB/00 22/02/19 Jan-22 STP/FG/BP/AMB/00 22/02/19 Jan-22
17 Pregablin SPEC/FG/PAC-IV/00 01/06/17 May-20 NA
18 Pregablin SPEC/FG/IP/PAC/00 25/02/19 Jan-22 STP/FG/IP/PAC/00 25/02/19 Jan-22
19 Albendazole IP SPEC/FG/IP/ALB/00 29/08/19 Jul-22 STP/FG/IP/ALB/00 29/08/19 Jul-22
20 Albendazole EP SPEC/FG/EP/ALB/00 29/08/19 Jul-22 STP/FG/EP/ALB/00 29/08/19 Jul-22
21 Albendazole BP SPEC/FG/BP/ALB/00 29/08/19 Jul-22 STP/FG/BP/ALB/00 29/08/19 Jul-22
22 Fluconazole USP SPEC/FG/USP/FLU/00 23/02/19 Jan-22 STP/FG/USP/FLU/0023/02/19 Jan-22
23 Fluconazole IP SPEC/FG/IP/FLU/00 23/02/19 Jan-22 STP/FG/IP/FLU/00 23/02/19 Jan-22
24 FPS SPEC/FG/FPS/00 26/08/19 Jul-22 STP/FG/FPS/00 26/08/19 Jul-22
25 Vildagliptin SPEC/FG/VLD/00 26/08/19 Jul-22 STP/FG/VLD/00 26/08/19 Jul-22
Sr.No. Month Magnehelic Gauge Temperature
1 Jan-19
2 Feb-19
3 Mar-19
4 Apr-19
5 May-19
6 Jun-19
7 Jul-19
8 Aug-19
9 Sep-19 Pending(1 to 30) 1 to 11 Sept-OK
10 Oct-19
11 Nov-19
12 Dec-19 07/12/19 onwards pending 02/12/19 onwards pending
Weighing Balance-4 Cleaning & housekeeping of Production area

1 to 18 Sept-Ok 23 sept onwards sign Pending (Ground floor and first Floor)

09/12/19 onwards pending 1st floor (8Dec-19 onwards Pending), Ground Floor 15/12/19
Drying Area Cleaning of Walls, glass, panel, ceiling, rack and electrical panel

20/09/19 ONWARDS pending 01/09/19 to 112/09/19 OK-Remaining Pending

15/12/2019 onwards pending 09/12/19 onwards Pending

ck and electrical panel
1 Self Inspection Production Observation given Response still Pending
2 Self Inspection QA Pending
3 Self Inspection QC Pending
4 Self Inspection Engineering Pending
5 Self Inspection Store Pending
6 Retain Sample Storage Condition need to maintain
7 Retain Sample QC Retain Sample of 2016-17-18 Analysis of FG for confirm Shelf Life
Stability Protocol for all Product
DFA
TNL
8 Stability
DEN
ALB
FPS
NV Project Glycocholic Acid
IP/IM Spec MOA 20 Spec/MOA
9 BMR 12 BMR Verification 8 commercial+4 DEMO
QC Analysis to be completed 8 commercial+4 DEMO
IP Sample Pending/Analysis Pending 8 commercial+4 DEMO
All Products
DFA Data Collection Batch Data, Change Control, Deviation,RM change, Vendor Qualification
TNL
10 APQR
DEN
ALB
FPS
Sheet No.4 All Pending
11 Vendor Vendor Qualification Service Contract Agency
Outside Laboratory
12 FG Data 2019/2020 all Pending
13 Fluco Deficiency Pending
BMR Master
Spec-MOA Master
Stability Data
Filled Batch BMR
14
Process Validation
Cleaning Validation
IP Data
Finished Data
BMR Master
Spec-MOA Master
Stability Data
Filled Batch BMR
15
Process Validation
Cleaning Validation
IP Data
Finished Data
BMR Master
Spec-MOA Master
Stability Data
Filled Batch BMR
16
Process Validation
Cleaning Validation
IP Data
Finished Data
2-IP SPEC-MOA shall prepared
1-FP
17 Bromo Indol
9-RM
BMR for Bromo Indol-3 BMR
 Process Validation

Validation
Validation Production QC IP QC FP
Sr.No. Product Name Batch No. Complete Remarks
Start Date Data Data Data
Date

DEN-19-I-0003 30/11/2019 03/12/2019 Completed Completed Completed

1 DEN-I
DEN-19-I-0004 02/12/2019 05/12/2019 Completed Completed Completed
DEN-19-II-0003 08/12/2019 10/12/2019 Completed Completed Completed
2 DEN-II DEN-19-II-0004 11/12/2019 13/12/2019 Completed Completed Completed
DEN-19-II-0005 14/12/2019 16/12/2019 Completed Completed Completed
DEN-19-III-0003 21/12/2019 24/12/2019 Completed Completed Completed
3 DEN-III
DEN-19-III-0004 28/12/2019 01/01/2020 Completed Completed Completed
TNL-20-I-0001 17/01/2020 21/01/2020 Completed Completed Completed
4 TNL-I TNL-20-I-0002 21/01/2020 24/01/2020 Completed Completed Completed
TNL-20-I-0003 27/01/2020 31/01/2020 Completed Completed Completed
ALB-20-IV-0021 13/06/2020 15/06/2020 Completed Completed Pending
5 ALB-IV ALB-20-IV-0022 15/06/2020 16/06/2020 Completed Completed Pending
ALB-20-IV-0023 16/06/2020 18/06/2020 Completed Completed Pending
DFA-20-I-0001 07/01/2020 10/01/2020 Completed Pending Pending
6 DFA-I DFA-20-I-0002 12/01/2020 15/01/2020 Completed Pending Pending
DFA-20-I-0003 15/01/2020 18/01/2020 Completed Pending Pending
DFA-20-II-0001 12/01/2020 13/01/2020 Completed Pending Pending
7 DFA-II DFA-20-II-0002 16/01/2020 17/01/2020 Completed Pending Pending 150 Kg
DFA-20-II-0003 18/01/2020 20/01/2020 Completed Pending Pending
DFA-20-III-0001 14/01/2020 17/01/2020 Completed Pending Pending
8 DFA-III DFA-20-III-0002 17/01/2020 21/01/2020 Completed Pending Pending
DFA-20-III-0003 21/01/2020 24/01/2020 Completed Pending Pending
9 FLU-I FLU-20-I-0003
10 FPS-I
11 FPS-II
12 FPS-III

4-Product Pending
 Cleaning Validation

Next Validation
Product Next Batch Validation Production
Sr.No. Batch No. Product Complete QC Data Remarks
Name for CV Start Date Data
Name Date

1 DEN-III DEN-19-III-0004 DFA-I DFA-20-I-0001 30/12/2019 01/01/2020 Completed Completed

2 TNL-1 TNL-20-I-0003 FPS-I FPS-20-I-0001 29/01/2020 31/01/2020 Completed Completed
3 ALB-IV ALB-20-IV-0023 FPS-I PENDING PENDING PENDING PENDING PENDING PENDING
4 DFA-I DFA-20-III-0003 FPS-I PENDING PENDING PENDING PENDING PENDING PENDING
5 FLU-I PENDING PENDING PENDING PENDING PENDING PENDING
6 FPS-II PENDING PENDING PENDING PENDING PENDING PENDING
7

4-Batch Pending
 Qualification

Sr.No. Equipment Name Equipment ID Protocol No. Qualification Date Requalification Date Remarks
1 Reactor RE-01-001 DPCPL/RQ/001 07/08/2018 07/08/2021
2 Reactor RE-01-002 DPCPL/RQ/002 08/08/2018 08/08/2021
3 Reactor RE-01-003 DPCPL/RQ/003 09/08/2018 09/08/2021
4 Reactor RE-01-004 DPCPL/RQ/004 NA
5 Reactor RE-01-005 DPCPL/RQ/005 13/08/2018 13/08/2021
6 Reactor RE-01-006 DPCPL/RQ/006 16/08/2018 16/08/2021
7 Reactor RE-01-007 DPCPL/RQ/007 06/08/2018 06/08/2021
8 Reactor RE-01-008 DPCPL/RQ/008 11/08/2018 11/08/2021
9 Reactor RE-01-009 DPCPL/RQ/009 NA
10 Reactor RE-01-010 DPCPL/RQ/010 14/08/2018 14/08/2021
11 Reactor RE-01-011 DPCPL/RQ/011 NA
12 Reactor RE-01-012 DPCPL/RQ/012 NA
13 Reactor RE-01-013 DPCPL/RQ/013 28/08/2018 28/08/2021
14 Reactor RE-01-014 DPCPL/RQ/014 29/08/2018 29/08/2021
15 Reactor RE-01-015 DPCPL/RQ/015 29/08/2018 29/08/2021
16 Reactor RE-01-016 DPCPL/RQ/016 30/08/2018 30/08/2021
17 Reactor RE-01-017 DPCPL/RQ/017 26/08/2018 26/08/2021
18 Reactor RE-01-018 DPCPL/RQ/018 27/08/2018 27/08/2021
19 Reactor RE-01-019 DPCPL/RQ/019 01/09/2018 01/09/2021
20 Centrifuge CF-01-002 RVR/P/CF/20/002 22/05/2020 22/05/2023
21 Centrifuge CF-01-003 RVR/P/CF/20/003 22/05/2020 22/05/2023
22 Centrifuge CF-01-004 RVR/P/CF/20/004 22/05/2020 22/05/2023
23 Centrifuge CF-01-005 RVR/P/CF/20/005 22/05/2020 22/05/2023
24 Stability Chamber Completed Completed
25 HPLC Qualification Completed Completed
26 GC Qualification Completed Completed
27 Multimill
28 Sifter
29 Blender
30 Air Tray Dryer
31 Vaccum Tray Dryer
32 RCVD
Sr.No. Technology Transfer
1 Master Formula Record
2 ROS
3 BMP
4 User Trial Data
Sr.No. Description SOP No. Status
1 Material Enter in Premises
Vehicle entry in Gate
Security Person inform to Warehouse person.
1 SG001 Effective
Check physical condition of material and cleanliness
Filled the checklist as per SOP
2 WAREHOUSE
Material shall be checked as per MSDS, as per COA, Free
from Dust, Free from External particles and in Good
Condition
SG001 Not Effective
Ware-house person shall fill the checklist with reference
to COA, MSDS, Physical verification and then keeping
1 down the material from the truck
Material goes from De-dusting process and Kept with
AG020 Effective
Quarantine label in Quarantine Area
Prepared GRN and inform to QC Person for Sampling of
SG002 Effective
incoming Material
3 QC
QC Person Samples the material(RM/PM) & fixed
Not Effective
Sampled Material and Under Test Labeled on it.
1 After Completion of analysis QC shares the result with
QA and QA shall release the Material with approved AG020 Effective
Label
4 Dispensing of Material (Production, Store and QA)
At the time of Material Dispensing Store person shall
dispensed the material with Details like Material Name,
Material Code, A.R.No. Gross Wt., Tare Wt., Net Wt. n SG003 Effective
Dispensed on date and Sign off store and Production
person
1
Material Dispensing shall be done in presence of QA Not Effective

QA shall Verify all the material and Status tag and then
Not Effective
Material shall sent to Production for Batch Planning.

Entry-Exit in Dispensing Area SG011 Not Effective

5 Line Clearance
 At the time of Batch, Before starting of Batch Production
person inform to QA for Line Clearance, QA and
Production department Both shall verify previous remnant
QA-009-00Not Effective
of previous product, Cleaning record of Equipment,
Previous batch Record completion record current batch
ready to planning.

At the time of line Clearance Status board shall be

updated, Qualification of Reactor shall be done,
1 QA-009-00Not Effective
Preventive maintenance shall completed, Calibration tag
shall be updated as per cGMP norms
On Status board current stage description shall be updated
PG009/01 Not Effective
and Sign date required for the same.
Online in process activity shall be done and all entry shall
Not Effective
done on same time not on previous Time.
In Inprocess activity affixed the label as per stage wise.
Not Effective
Like Wet/Dry Material, Recover Solvent etc.
6 Inprocess Analysis
Inprocess sample shall be sent to QC in Dedicated Bottles
for Product with Inprocess Label with details like batch
no, Product Name, Test requires, Test request slip no.
Sign date.
QC Department shall perform analysis as per related
Product In process and Intermediate Spec-MOA.
QC Department shall gives in process result within time
frame and after that production continuing another Respectiv Effective
activity.
After Receiving Inprocess result production continues
next in process for batch, fill the in process result Not Effective
1 provided by QC department.
At the time of different intervals Production department
sent the samples and note down the results.

After completion of Drying process Production

department sent final Finished Samples to QC Department Not Effective
for analysis and QC Perform analysis as per SPEC-MOA.

QC Department shall note down all the analysis in

QG028 Not Effective
respective Testing Worksheet.

After Completion of Finished Analysis Batch is ready to

Not Effective
Dispatch.

7 Batch Release
 QA Person shall verify all the documents starting from
Material request slip production to Warehouse, Material
provided to Production by Store (Warehouse to
Production slip), Equipment Usage like Reactor,
Centrifuge, Sparkler, Nutch filter, Tray Dryer etc. Not Effective
cleaning record and T.R Slip with Results. Batch
Manufacturing in process documents like T.R Slips,
Results etc. are well within Criteria, and no any deviation
found during the process.

After Inprocess data QA shall Verify all Finished data and

Not Effective
go for Dispatch.

Dispatch Officer shall fill the Pre-Dispatch Checklist with

reference to Party P.O, Purchase department shall provide
Not Effective
the P.O for the Same. Purchase department shall provide
1 P.O with Party name, PO no. Pack Style etc.

Dispatch Officer shall prepare the label as per

Not Effective
requirement and verification shall be done by QA Person.

QC Department Prepared the COA as per Release

Not Effective
formalities and Sent it to QA for Final Verification.
QA Shall fill the checklist for batch Release with details
like Product Name, Batch Number, Manufacturing/Expiry
Date and Dispatch Qty. and filled the checklist for AG025 Effective
documents availability and finally release the batch in the
market.
QA shall verify PO, Invoice, COA, E-Way bill, MSDS of
Material etc. commercial and technical documents and Not Effective
then release the batch.
8 QMS System
Change Control Management AG002 Effective
Deviation Management AG010 Effective
CAPA Management AG011 Effective
Investigation Handling AG013 Not Effective
Market Complaint AG012 Not Effective
1
Product Recall QA-020-00Not Effective
Product Reprocess QA-023-00Not Effective
Risk Assessment NA NA
Computer System Validation NA NA
Transport Validation NA NA
9 Equipment Qualification
 Reactor NA Completed

Centrifuge NA Completed

Tray Dryer Not EffectiPending

RCVD Not EffectiPending

Sparkler Filter Not EffectiPending

Nuetch filter Not EffectiPending

1
Multi mill Not EffectiPending

Sifter Not EffectiPending

Water Qualification Not EffectiPending
HVAC Qualification (Differential Pressure Maintanance) Effective Pending
Filter Validation Not Effective
Temperature monitoring
Stability Chamber CompletedCompleted
HPLC Qualification CompletedCompleted
GC Qualification CompletedCompleted
10 Specification & MOA
RM Spec & MOA QG027

Inprocess QG027

Finished Product QG027

1 Intermediate QG027 Effective

Cleaning QG027

Testing Worksheet QG028

Packing Material QG027

11 Documentation
Document Numbering/Equipment Numbering AG003 Completed
MSDS Completed
Self Inspection AG009 Not Effective
Training AG004 Not Effective
 Vendor Qualification AG007 Not Effective

Retain Sample AG019 Not Effective

Shelf Life Assigning NA NA

Stability AG022 Not Effective

1
Contract Lab agreement AG015 Effective

Batch Release (System) AG025 Not Effective

Data Integrity (Back log) NA Not Effective

Technology Transfer AG028 Not Effective
Hold Time Study (Product) NA Not Effective
Equipment cleaning Hold Time Study NA Not Effective
Analytical method Validation NA Not Effective
APQR AG018 Not Effective
Pending BMR NA NA
12 QC
Raw Material Analysis
Chemicals
Date & Time Modification
Sample Storage/Material Storage
Water Analysis
1
Individual Login
Reference Standard
Impurities
Working Standards
Calibration of all equipments/Instruments
13 Production/Store/Engineering
Cleaning Record of Area, Equipment
Logbooks
Batch Records on time
Material Verification
Batch Charge in Presence of QA (Line Clearance)
Inprocess Activity
Product Labelling
Equipment Maintanance Record
Preventive Maintanance and Breakdown Maintanance
Status Updation
Labelling Procedure
Online Activity
Dispensing Procedure
1 Entry-Exit in QC, Production and Dispensing Area
Different Utensil for Different Material
1

Dispensing in Dispensing Booth

Palletization of all material
Material Segregation (Quarantine/Under
Test/Approved/Rejected)
Air Curtains
Insectisizer
Pipe line Numbering
Batch Size finallize
Following Batch Records and SOP in Production Area
Restriction of food in GMP Area

Restriction of Tobacco chewing/Smoking in Plant Premises

 GMP REQUIIREMENTS

Reason Action Plan

NA NA

Vendor not providing COA/MSDS Need to Ask Vendor for COA and MSDS

Label for Quarantine Pasted, when material received

NA
from vendor

NA NA

Single Person in QC. No helper even to do

New Recruitment Required
the same

Analysis for RM/PM not done due to

New Recruitment Required/Procurement Requirement
insufficient Manpower and Chemicals

NA NA

Line Clearance and Proper Dispensing Method need to

Some tme informing before Dispensing
follow
Less Serious ness related Dispensing Line Clearance and Proper Dispensing Method need to
(Mixing of Material)Contamination follow
Gowning not available. Less GMP
New Procurement of Gowns
awareness
Lack awareness about Line clearance
Lack awareness about Line clearance
Not wanted to do online… dependent on
Each other
Dependent on Each Other
Dependent on Each Other
NA
Management Pressure/Ignorance of
Production Department/HOD inawareness related to this
All Analysis not possible due to single
manpower
Single Manpower
No one want to wait for result.
Due to Management Pressure for
Dispatch/Casual way for dispatch
Trraining impartion
Trraining impartion
Training. (Strict Words by Management for the Online
Activity)
Training. (Strict Words by Management for the Online
Activity)
Training. (Strict Words by Management for the Online
Activity)
NA
Work as per cGMP/Training/Management involvement
New Manpower need to Enrolled in qc
New Manpower need to Enrolled in QC
Work as per cGMP/Training/Management involvement
related to this
Timely not providing Document Online documentation

Timely not providing Document Online documentation

Inadaquate Manpower New Manpower need to Enrolled in Production

Inadaquate Manpower New Manpower need to Enrolled in Production

Inadaquate Manpower New Manpower need to Enrolled in QC

NA NA

PO/Invoice/COA/E-way bill shall verified

New Manpower need to Enrolled in QC
by QA but Technical Documents not
Production also
received from Production/QC

NA
NA
NA
Department Personal Does not have Basic
Knowledge about Investigation
No such Information related
No such Information related
Officialy not showing by Production and
management
Need to started in Second Phase
Need to started in Second Phase
Need to started in Second Phase
Training. (Strict Words by Management for the
Activity)
Management need to involve in this.
Management need to involve in this.
Management need to involve in this. Training Required
QA/All Deparrtment
QA/All Deparrtment
QA/All Deparrtment
NA NA

NA NA

Manpower Requirement to complete this

Need to recruit Manpower for rQualification
all activity
Manpower Requirement to complete this
Need to recruit Manpower for rQualification
all activity
Manpower Requirement to complete this
Need to recruit Manpower for rQualification
all activity
Manpower Requirement to complete this
Need to recruit Manpower for rQualification
all activity
Manpower Requirement to complete this
Need to recruit Manpower for rQualification
all activity
Manpower Requirement to complete this
Need to recruit Manpower for rQualification
all activity
Due to Corona Qualification Pending
Requalification Result awaiting
In Second Phase

All Specification and MOA need to Comply as per

IP/BP/USP. Needs to check with it.
All Specification and MOA need to Comply as per
IP/BP/USP. Needs to check with it.
All Specification and MOA need to Comply as per
IP/BP/USP. Needs to check with it.
All Specification and MOA need to Comply as per
IP/BP/USP. Needs to check with it.
All Specification and MOA need to Comply as per
IP/BP/USP. Needs to check with it.

On the basis of Spec and MOA TWS shall be prepared.

All Specification and MOA need to Comply as per

IP/BP/USP. Needs to check with it.
Only Documented Qualification done. Audit
of Vendor not done.

After Starting of Stability Chamber we can provide shelf life

Stability Chamber not in working Condition
of Product
After Starting of Stability Chamber we'can start the activity
Stability Chamber not in working Condition
related stability
Based on documents.

Improper dispatch Method. No. of Batch mix Training and Management restriction for This kind of
up.Result not okk till batch sent to parties Activity

Not aware with this.

No such related data available
Started in Second phase
Started in Second phase
Started in Second phase
Lacking of Manpower Manpower requirement.
Responsibility Target Date

Security Person NA

Purchase

Store Person

Store Person/Purchase

Management/HR

Management/HR/Purchase

Store

Production /QA

Production /Store/QA

Management/Purchase
Production/QA

Production/QA

Production/QA/
Management
Production/QA/
Management
Production/QA/
Management

QC

Production/QA/
Management

Management/HR

Management/HR

Production/QA/
Management
Production/QA

Production/QA

Management/HR

Management/HR

Management/HR

QA

Management/HR

Production/QA/Management
QA/Management
QA/Management
Production/QA/Management
QA/Concern Department NA

QA/Concern Department NA

QA/management/HR

QA/management/HR

QA/management/HR

QA/management/HR

QA/management/HR

QA/management/HR
QA/Management
QA/Validair Engineers

QA/QC/Management to provide Pharmacopea

QA/QC

QA/QC

QA/Production/Management

Management/HR
Remarks

Gujarati

Sampling SOP not Available

Refer Attachment-1 Chemical list Pending

15
Calibration Certificate Pending from
Krishna Calibration due to Payment
Pending

1 Person Required for Qualification

Himanshu Shah Owner

 Production/Store

Material Entry
RM checklist as per Approved Vendor list COA MSDS Qty
Material De-dusting
Material quarantine
Under Test
Approved
Dispensed
Net wt.Tare Wt.
Under RLAF
With A.R.no
Reactor Cleaning
ECR
QC Approval
Lineclearance
BMR
Logbbok
Status Board
Proper Labelling
On going entry
BMR Completion
Packing Shifting
Milling
Blending
Batch Release-Checklist
Batch Packing
Label Verification
Packing Requirement Verification

QC
RM Analysis
Material Under Test
Approved
Inprocess Analysis
Testing Worksheet (Raw Data Compiliation)
Finished Analysis (Analysis Data)
COA-Release
Calibration of Instruments
Logbook Entry
Qualification of Instruments
Working Standard
Reference Standard
Specification/MOA as per IP/BP/USP
Testing Worksheet as per Spec-Moa
Review of analytical Data
Audit Trial of All Instruments
Print from Instruments
Chemicals

QA
Numbering of Equipment/Instrument/Documents
SOPs
Product Recall
Mock Recall
Market Complaint
Eequipment Cleaning Hold time (dirty Equipment Hold time)
Product Hold time
data Integrity
No Back Log
Qualification of All equipments
Process Validation
Cleaning Validation
APQR
Self Inspection/Internal Audit
Vendor Qualification
Online Activity
Technology Transfer
document Numberiing
Retain Sample
Stability
Shelf life Assigning
Batch Release Parameters
document Review
approved Vebdor list
Master SOP Index/Spec-MOA Index/Equipment List/Equipment Matrix
BMR Review
 GMP Requirements
Sr.No. Material Enter in Premises
1 Vehicle entry in Gate
2 Security Person inform to Warehouse person.
3 Check physical condition of material and cleanliness
4 Filled the checklist as per SOP
Ware House
Material shall be checked as per MSDS, as per COA, Free from Dust, Free
1
from External particles and in Good Condition
Ware-house person shall fill the checklist with reference to COA, MSDS,
2
Physical verification and then keeping down the material from the truck
Material goes from De-dusting process and Kept with Quarantine label in
3
Quarantine Area

4 Prepared GRN and inform to QC Person for Sampling of incoming Material

QC
QC Person Samples the material fixed Sampled Material and Under Test
1
Labeled on it
After Completion of analysis QC shares the result with QA and QA shall
2
release the Material with approved Label
Dispensing of Material (Production, Store and QA)

1 At the time of Material Dispensing Store person shall dispensed the material
with Details like Material Name, Material Code, A.R.No. Gross Wt., Tare
Wt., Net Wt. n Dispensed on date and Sign off store and Production person
2 Material Dispensing shall be done in presence of QA
3 QA shall Verify all the material and Status tag and then Material shall sent to
Production for Batch Planning.
Line Clearance
At the time of Batch, Before starting of Batch Production person inform to
1 QA for Line Clearance, QA and Production department Both shall verify
previous remnant of previous product, Cleaning record of Equipment,
Previous batch Record completion record current batch ready to planning.
At the time of line Clearance Status board shall be updated, Qualification of
2 Reactor shall be done, Preventive maintenance shall completed, Calibration
tag shall be updated as per cGMP norms
3 On Status board current stage description shall be updated and Sign date
required for the same.
4 Online in process activity shall be done and all entry shall done on same time
not on previous Time.
5 In Inprocess activity affixed the label as per stage wise. Like Wet/Dry
Material, Recover Solvent etc.
Inprocess Analysis
Inprocess sample shall be sent to QC in Dedicated Bottles for Product with
1 Inprocess Label with details like batch no, Product Name, Test requires, Test
request slip no. Sign date.

2 QC Department shall perform analysis as per related Product In process and

Intermediate Spec-MOA.
3 QC Department shall gives in process result within one hour and after that
production continuing another activity.
4 After Receiving result production continues next in process for batch, fill the
in process result provided by QC department.
5 At the time of different intervals Production department sent the samples and
note down the results.
After completion of Drying process Production department sent final
6 Finished Samples to QC Department for analysis and QC Perform analysis
as per SPEC-MOA.
7 QC Department shall note down all the analysis in respective Testing
Worksheet.
8 After Completion of Finished Analysis Batch is ready to Dispatch.
Batch Release

QA Person shall verify all the documents starting from Material request slip
1 production to Warehouse, Material provided to Production by Store
(Warehouse to Production slip), Equipment Usage like Reactor, Centrifuge,
Sparkler, Nutch filter, Tray Dryer etc. cleaning record and T.R Slip with
Results. Batch Manufacturing in process documents like T.R Slips, Results
etc. are well within Criteria, and no any deviation found during the process.
2 After Inprocess data QA shall Verify all Finished data and go for Dispatch.

3 Dispatch Officer shall fill the Pre-Dispatch Checklist with reference to Party
P.O, Purchase department shall provide the P.O for the Same. Purchase
department shall provide P.O with Party name, PO no. Pack Style etc.
4 Dispatch Officer shall prepare the label as per requirement and verification
shall be done by QA Person.
5 QC Department Prepared the COA as per Release formalities and Sent it to
QA for Final Verification.
 QA Shall fill the checklist for batch Release with details like Product Name,
6 Batch Number, Manufacturing/Expiry Date and Dispatch Qty. and filled the
checklist for documents availability and finally release the batch in the
market.
7 QA shall verify PO, Invoice, COA, E-Way bill, MSDS of Material etc.
commercial and technical documents and then release the batch.

1 Documentation
1 Document Numbering/Equipment Numbering Yes
2 MSDS Yes
3 Self Inspection Yes
4 Training Yes
5 Vendor Qualification Yes
6 Retain Sample Yes
7 Shelf Life Assigning
8 Stability
9 Contract Lab agreement Yes
10 Batch Release (System) Yes
11 Data Integrity (Back log)
12 Technology Transfer Yes
13 Hold Time Study (Product)
14 Equipment cleaning Hold Time Study
15 Analytical method Validation
16 APQR Yes
17 RM Spec & MOA NTC
18 Inprocess NTC
19 Finished Product NTC
20 Intermediate NTC
21 Cleaning NTC
22 Testing Worksheet NTC
23 Packing Material NTC
2 QC
1 Raw Material Analysis NA
2 Chemicals NTC
3 Date & Time Modification
4 Sample Storage/Material Storage NA
5 Water Analysis NA
6 Individual Login NA
7 Reference Standard NA
8 Impurities NA
9 Working Standards NA
10 Calibration of all equipments/Instruments Yes
3 QMS
1 Change Control Management Yes
2 Deviation Management Yes
3 CAPA Management Yes
4 Investigation Handling Yes
5 Market Complaint Yes
6 Product Recall OLD
7 Product Reprocess OLD
8 Risk Assessment NA
9 Computer System Validation NA
10 Transport Validation NA
11 Cleaning Validation Yes
12 Process Validation Yes
4 Qualification
1 Reactor Yes
2 Centrifuge
3 Tray Dryer
4 RCVD
5 Sparkler Filter
6 Nuetch filter
7 Multi mill
8 Sifter
9 Water Qualification
10 HVAC Qualification (Differential Pressure Maintanance)
11 Filter Validation
12 Temperature monitoring NA
13 Stability Chamber Yes
14 HPLC Qualification Yes
15 GC Qualification Yes
5 Production
1 Cleaning Record of Area, Equipment
2 Logbooks
3 Batch Records on time
4 Material Verification
5 Batch Charge in Presence of QA (Line Clearance)
6 Inprocess Activity
7 Product Labelling
8 Equipment Maintanance Record
9 Preventive Maintanance and Breakdown Maintanance
10 Status Updation
11 Labelling Procedure
12 Online Activity
13 Dispensing Procedure
14 Entry-Exit in QC, Production and Dispensing Area
15 Different Utensil for Different Material
16 Dispensing in Dispensing Booth
17 Palletization of all material
18 Material Segregation (Quarantine/Under Test/Approved/Rejected)
19 Air Curtains
20 Insectisizer
21 Pipe line Numbering
22 Batch Size finallize
23 Following Batch Records and SOP in Production Area
24 Restriction of food in GMP Area
25 Restriction of Tobacco chewing/Smoking in Plant Premises