LST-QA-001 - Master List of Documents
LST-QA-001 - Master List of Documents
LST-QA-001
Levram Lifesciences Pvt. Ltd.
Effective Date 09-04-2023
Revision No. 00
Title- Master List of Documents
Page No. 1 of 14
Rev.
Sr. No. Department Document name Documents Type Document no.: W.E. F Next Rev. Date
No.
1 Quality Assurance Quality Manual Manual LLPL-QA-QM-9001-001 14-09-2023 13-09-2028 0
2 Quality Assurance Quality Manual Manual LLPL-QA-QM-13485-002 14-09-2023 13-09-2028 0
3 Quality Assurance Plant Master File (Unit 1) File LLPL-QA-PMF-001 21-01-2023 16/01/2028 0
4 Quality Assurance Plant Master File (Unit 2) file LLPL-QA-PMF-002 21-01-2023 16-01-2028 0
5 Quality Assurance Plant Master File (Unit 3) file LLPL-III-PMF-003 06/09/2027 0
6 Quality Assurance Plant Master File (Unit 4) file LLPL-QA-PMF-004
7 Quality Assurance Supplier Quality Management Manual Manual LLPL-QA-SQMM-23 20-09-2023 20-09-2023 0
8 Quality Assurance SOP for SOP SOP LLPL-QA-001 20-09-2023 20-09-2023 0
9 Quality Assurance Control of Document SOP LLPL-QA-002 20-09-2023 20-09-2023 0
10 Quality Assurance Control of records SOP LLPL-QA-003 20-09-2023 20-09-2023 0
Procedure for handling of
11 Quality Assurance SOP LLPL-QA-REC-25 20-09-2023 14-09-2023 0
returned/expired/control samples
procedure for Rework, Retesting and
12 Quality Assurance SOP LLPL-QA-RRR-36 20-09-2023 14-09-2023 0
Revaluation
Handling of Returned / Rejected
13 Quality Assurance SOP LLPL-QA-RG-51 20-09-2023 14-09-2028 0
Goods
14 Quality Assurance CAPA SOP LLPL-QA-CAPA-27 20-09-2023 14-09-2023
15 Quality Assurance SOP for Incident reporting SOP 20-09-2023 14-09-2023 0
16 Quality Assurance Deviation Control SOP LLPL-QA-28 20-09-2023 13-04-2023 1
17 Quality Assurance sop or GMP SOP LLPL-QA- 20-09-2023 14-09-2023 0
18 Quality Assurance Safety Manual SOP LLPL-QA-SFM-35 20-09-2023 14-09-2023 0
19 Quality Assurance Quality Assurance Plan Plan LLPL-QA- 20-09-2023 14-09-2023 0
20 Quality Assurance Management Review Meeting SOP LLPL-QA- 0
21 Quality Assurance Post Market Surveillance SOP LLPL-QA-PMS-00 20-09-2023 14-09-2023 0
Doc. No. LST-QA-001
Levram Lifesciences Pvt. Ltd.
Effective Date 09-04-2023
Revision No. 00
Title- Master List of Documents
Page No. 2 of 14
pad 5mm)
Raw Material specification (Conjugate
Quality Control Specification LLPL//III/QA/RM/CP1/001 25-06-2021 24-05-2023 0
pad 10mm)
Raw Material specification (Absorbent
Quality Control Specification LLPL//III/QA/RM/AP/001 25-06-2021 24-05-2023 0
Pad 18mm)
Raw Material specification (Absorbent
Quality Control Specification LLPL//III/QA/RM/AP1/001 25-06-2021 24-05-2023 0
pad 21mm)
Raw Material specification (Blood
Quality Control Specification LLPL/III/QA/RM/BS/001 25-06-2021 24-05-2023 0
Seperator 09mm)
Raw Material specification (Plastic
Quality Control Specification LLPL//III/QA/PM/PC/001 25-06-2021 24-05-2023 0
Cassetes)
Quality Control Raw material testing specification Specification LLPL/III/QC/RMTS/001 25-06-2021 NA 0
Raw Material specification (Membrane
Quality Control Specification LLPL/III/QA/RM/M/001 25-06-2021 24-05-2023 0
SS-15 25mm)
Production Solution preparation SOP LLPL/I/SOP/QC/SPR/002 31/10/2020 30/10/2025 1
LLPL/III/SP/VTM/SOP/
Production VTM solution preparation - 2 SOP 19/04/2021 14/04/2026 0
SPN-2/001
Sop of Monoclonal antibody solution
Production SOP LLPL/III/QA/SOP/MAS/001 26/07/2021 19-07-2026 0
for immobilization process
Sop for cleaning instruction for
Production SOP LLPL/III/QA/SOP/CII/001 26/07/2021 19-07-2026 0
instrument
Production Sop for sample dilution SOP LLPL/III/QA/SOP/SD/001 26/07/2021 19-07-2026 0
Production Sop of drying of silica gel SOP LLPL/III/QA/SOP/DSG/001 26/07/2021 19-07-2026 0
Sop of preparation of reagent (Assay
Buffer/Diluent Buffer/Extraction Buffer)
Production SOP LLPL/III/QA/SOP/POR/001 26/07/2021 19-07-2026 0
for immobilization of capture
antibodies
Sop of drying and packaging of
Production SOP LLPL/III/QA/SOP/DPC/001 26/07/2021 19-07-2026 0
conjugate labelled antibody
Doc. No. LST-QA-001
Levram Lifesciences Pvt. Ltd.
Effective Date 09-04-2023
Revision No. 00
Title- Master List of Documents
Page No. 7 of 14
Utility
Maintenance &
Sop for Breakdown Maintenance SOP LLPL/III/MNT/SOP/BM/001 26-07-2021 19-07-2026 0
Utility
Maintenance & Sop for inspection/ cleaning of filter LLPL/III/MNT/SOP/AHU/
SOP 26-07-2021 19-07-2026 0
Utility AHU system 001
Maintenance & Sop for Preventive maintenance of LLPL/III/QA/SOP/PMAHU/
SOP 26-07-2021 19-07-2026 0
Utility AHU & Ventilation Unit 001
Maintenance & Sop of preventive maintenance of
SOP LLPL/III/QA/R/PMEI/001 26-07-2021 19-07-2026 0
Utility Electrical Instrument
Maintenance & Sop for Preventive maintenance of LLPL/III/QA/SOP/PMAHU/
SOP 26-07-2021 19-07-2026 0
Utility dehumidifier 001
Maintenance & Sop for Planned Preventive LLPL/III/QA/SOP/PPMP/
SOP 26-07-2021 19-07-2026 0
Utility maintenance program 001
Instrument Electrolyte Analyzer Work Instruction LLPL/I/SOP/QC/ELA/002 31/10/2020 30/10/2025 1
Instrument Coagulometer Work Instruction LLPL/I/SOP/QC/CGL/002 31/10/2020 30/10/2025 1
Instrument Fully automatic biochemistry analyzer Work Instruction LLPL/I/SOP/QC/BIA/002 31/10/2020 30/10/2025 1
Instrument Refrigerator Work Instruction LLPL/I/SOP/QC/RFG/002 31/10/2020 30/10/2025 1
Instrument Hot Air Oven Work Instruction LLPL/I/SOP/QC/HAO/002 31/10/2020 30/10/2025 1
Instrument Magnetic stirrer with hot plate Work Instruction LLPL/I/SOP/QC/MS/002 31/10/2020 30/10/2025 1
Instrument TDS Meter Work Instruction LLPL/I/SOP/QC/TDS/002 31/10/2020 30/10/2025 1
Instrument Centrifuge machine Work Instruction LLPL/I/SOP/QC/CEN/002 31/10/2020 30/10/2025 1
Instrument Digital weighing machine Work Instruction LLPL/I/SOP/QC/DWM/002 31/10/2020 30/10/2025 1
Instrument Automatic haematology analyser Work Instruction LLPL/I/SOP/QC/AHEA/001 31/10/2020 30/10/2025 1
LLPL/I/SP/PRP/SOP/BM/
Instrument Blister machine Work Instruction 27/06/2018 22/06/2023 0
001
LLPL/III/SP/VTM/SOP/
Instrument Chemical filling machine Work Instruction 22/02/2021 14/02/2025 0
FM/001
Instrument Digital pH meter Work Instruction LLPL/I/SP/VTM/SOP/ 01/01/2021 01/01/2025 0
Doc. No. LST-QA-001
Levram Lifesciences Pvt. Ltd.
Effective Date 09-04-2023
Revision No. 00
Title- Master List of Documents
Page No. 10 of 14
DPH/001
LLPL/I/SOP/IMM/
Instrument IMM ASWA 250 Work Instruction 02/02/2021 27/01/2025 1
ASWA250/002
LLPL/I/SOP/IMM/
Instrument IMM ASWA 150 Work Instruction 02/02/2021 27/01/2025 1
ASWA150/002
Instrument Granulator Work Instruction LLPL/I/SOP/IMM/GR/002 02/02/2021 27/01/2025 1
LLPL/I/SOP/IMM/
Instrument Chiller 15 TR Work Instruction 02/02/2021 27/01/2025 1
CHI15/002
Instrument Cooling tower Work Instruction LLPL/I/SOP/IMM/CT/002 02/02/2021 27/01/2025 1
Instrument Dehumidifier Work Instruction LLPL/I/SOP/IMM/DH/002 02/02/2021 27/01/2025 1
LLPL/I/SOP/IMM/
Instrument Air handling unit Work Instruction 02/02/2021 27/01/2025 0
AHU1/002
LLPL/I/SOP/IMM/
Instrument Air handling unit II Work Instruction 02/02/2021 27/01/2025 0
AHU2/002
LLPL/I/SOP/IMM/
Instrument Chiller 7.5 TR Work Instruction 02/02/2021 27/01/2025 1
CHI7.5/002
Instrument Air compressor (VEERA) Work Instruction LLPL/I/IMM/SOP/AI-V/002 02/02/2021 27/01/2025 1
Instrument Air compressor CPB Work Instruction LLPL/I/IMM/SOP/AI-C/002 02/02/2021 27/01/2025 1
Instrument Zebra printer Work Instruction LLPL/I/SOP/P/ZP/002 20/07/2021 15/07/2025 1
Instrument Flexographic printer Work Instruction LLPL/I/SOP/P/FGP/002 02/01/2021 02/12/2025 1
Instrument Citizen printer Work Instruction LLPL/I/SOP/P/CTP/002 20/07/2021 15/07/2025 1
Instrument Gel Filling Machine Work Instruction LLPL/I-IV/SOP/GCM/001 21/04/2021 15/04/2026 0
Instrument SOP for Digital pH meter Work Instruction LLPL/PD/SOP/DPH/002 25/08/2022 20/08/2027 1
Instrument IVEN Machine Work Instruction LLPL/I/V/SOP/IVEN/001 21/09/2020 15/09/2021 0
Instrument Hongreat machine Work Instruction LLPL/I/V/SOP/HM/001 21/09/2020 15/09/2021 0
LLPL/II/QA/BCT/SOP/
Instrument Chemical spray assembly Work Instruction 05/02/2021 05/02/2025 0
SPM/001
Instrument Tube labelling machine Work Instruction LLPL/II/QA/SOP/BCT/LM/ 23/02/2021 18/02/2025 0
Doc. No. LST-QA-001
Levram Lifesciences Pvt. Ltd.
Effective Date 09-04-2023
Revision No. 00
Title- Master List of Documents
Page No. 11 of 14
001
LLPL/II/QA/BCT/SOP/
Instrument Tube oriental machine Work Instruction 10/02/2021 05/02/2025 0
TOM/001
LLPL/II/SOP/QA/BCT/
Instrument Cap stopper machine -2 Work Instruction 10/02/2021 05/02/2025 0
SOP/CS-2/001
Instrument Cap stopper machine-1 Work Instruction LLPL/I/SM/SOP/CRP/001 10/02/2021 05/02/2025 0
Instrument Shrink wrap machine Work Instruction LLPL/II/QA/BCT/SHW/001 10/02/2021 05/02/2025 0
Injection moulding machine Shibaura LLPL/II/QA/SOP/STD-
Instrument Work Instruction 24/07/2021 19/07/2025 0
td-250 250/001
LLPL/II/QA/SOP/
Instrument Injection moulding machine -230 Work Instruction 27/03/2021 22/03/2025 0
MILA230/001
LLPL/II/QA/SOP/
Instrument Injection moulding machine -150 Work Instruction 27/03/2021 22/03/2025 0
MILA150/001
Injection moulding machine milacron LLPL/II/QA/SOP/
Instrument Work Instruction 27/03/2021 22/03/2025 0
200 MILA200/001
LLPL/II/QA/IMM/SOP/
Instrument Digital weighing Machine Work Instruction 08/03/2021 03/03/2025 0
DWM/001
Instrument Needle labelling machine auto Work Instruction LLPL/II/QA/SOP/CAPA/001 23/02/2021 18/02/2025 0
LLPL/II/QA/NP/SOP/MM/
Instrument Needle labelling machine -manual Work Instruction 22/02/2021 17/02/2025 0
001
LLPL/II/QA/ESR/SOP/
Instrument ESR filter fitting manual Work Instruction 10/02/2021 05/02/2025 0
FFM/001
Instrument ESR filter auto Work Instruction LLPL/PD/SOP/DPH/001 10/02/2021 05/02/2025 0
Instrument ESR tube printing machine Work Instruction LLPL/II/QA/SOP/IA/004 10/02/2021 05/02/2025 0
LLPL/II/QA/RP/SOP/PUC/
Instrument Punching machine Work Instruction 08/03/2021 03/03/2025 0
001
LLPL/II/QA/RP/SOP/
Instrument Mixing mill Work Instruction 08/03/2021 03/03/2025 0
MXM/001
Instrument Vacuum compressor moulding Work Instruction LLPL/II/QA/RP/SOP/ 08/03/2021 03/03/2025 0
Doc. No. LST-QA-001
Levram Lifesciences Pvt. Ltd.
Effective Date 09-04-2023
Revision No. 00
Title- Master List of Documents
Page No. 12 of 14
VCMO/001
LLPL/II/QA/RP/SOP/KN/
Instrument Kneader machine Work Instruction 08/03/2021 03/03/2025 0
001
LLPL/II/QA/RP/SOP/
Instrument Compressor moulding machine Work Instruction 08/03/2021 03/03/2025 0
CMO/001
LLPL/II/QA/RP/SOP/BCM/
Instrument Bale cutter machine Work Instruction 08/03/2021 03/03/2025 0
001
Instrument Hot air oven Work Instruction LLPL/I/QA/SOP/HAO/001 08/03/2021 03/03/2025 0
LLPL/II/QA/UCT/SOP/CL/
Instrument Capping and labelling machine Work Instruction 20/03/2021 15/03/2025 0
001
LLPL/II/QA//UCT/SOP/
Instrument Pouch packaging machine Work Instruction 20/03/2021 15/03/2025 0
PPKG/001
Instrument Sop for operation of Refrigerator Work Instruction LLPL/III/QA/SOP/REG/001 26-07-2021 19-07-2026 0
Instrument Sop for operation of fire extinguisher Work Instruction LLPL/III/QA/SOP/FE/001 26-07-2021 19-07-2026 0
Instrument Sop for Operation of Deep Freezer Work Instruction LLPL/III/QA/SOP/DFZ/001 26-07-2021 19-07-2026 0
Instrument Sop for Operation of pH meter Work Instruction LLPL/III/QA/SOP/PH/001 26-07-2021 19-07-2026 0
Instrument Sop for Operation of Hot Air Oven Work Instruction LLPL/III/QA/SOP/HAO/001 26-07-2021 19-07-2026 0
Instrument Sop for Continuous Band Sealer Work Instruction LLPL/III/QA/SOP/SM/001 26-07-2021 19-07-2026 0
Instrument Sop for Operation of Vortex mixer Work Instruction LLPL/III/QA/SOP/VMX/001 26-07-2021 19-07-2026 0
Instrument Sop of Operation of Liminar Air flow Work Instruction LLPL/III/QA/SOP/LAF/001 26-07-2021 19-07-2026 0
Instrument Sop for Operation Strip Cutter Work Instruction LLPL/III/QA/SOP/LAF/001 26-07-2021 19-07-2026 0
Sop for Operation of Hot Plate LLPL/III/QA/SOP/HPMS/
Instrument Work Instruction 26-07-2021 19-07-2026 0
Magnetic Stirrer 001
Instrument Sop of blood mixer Work Instruction LLPL/III/QA/SOP/BMX/001 26-07-2021 19-07-2026 0
Instrument Sop of Autoclave Work Instruction LLPL/III/QA/SOP/AUT/001 26-07-2021 19-07-2026 0
Instrument Sop for Operation of weighing balance Work Instruction LLPL/III/QA/SOP/WB/001 26-07-2021 19-07-2026 0
Instrument Sop for operation of strip cutter Work Instruction LLPL/III/QA/SOP/SCT/001 07-07-2021 01-07-2026 0
Instrument Sop for Operation of Dispensing Work Instruction LLPL/III/QA/SOP/DPS/001 26-07-2021 19-07-2026 0
Doc. No. LST-QA-001
Levram Lifesciences Pvt. Ltd.
Effective Date 09-04-2023
Revision No. 00
Title- Master List of Documents
Page No. 13 of 14
System
Instrument Sop of micropipette Work Instruction LLPL/III/QA/SOP/MP/001 26-07-2021 19-07-2026 0
Instrument Sop of stopwatch Work Instruction LLPL/III/QA/SOP/SW/001 26-07-2021 19-07-2026 0
Instrument Sop of thermo-Hygrometer Work Instruction LLPL/III/QA/SOP/THM/001 26-07-2021 19-07-2026 0
Sop for Operation of Dynamic pass
Instrument Work Instruction LLPL/III/QA/SOP/DPB/001 26-07-2021 19-07-2026 0
box
Instrument Sop for Operation of Static pass box Work Instruction LLPL/III/QA/SOP SPB/001 26-07-2021 19-07-2026 0
Sop for Operation, Cleaning of
Instrument Work Instruction LLPL/III/QA/SOP/MP/001 23-01-2023 17-01-2028 0
Multichannel Pipette
Sop for Operation of Refrigerated
Instrument Work Instruction LLPL/III/QA/SOP/CEN/001 26-07-2021 19-07-2026 0
Centrifuge
Instrument Sop for Operation of Incubator Work Instruction LLPL/III/QA/SOP/INC/001 26-07-2021 19-07-2026 0
Instrument Dehumidifier Work Instruction LLPL/III/PD/SOP/DH/001 02/09/2021 27/09/2025 0
LLPL/IV/QA/SOP/JHW-
Instrument IMM JH WELLTECH-130 Work Instruction 27/06/2021 22/06/2025 0
130/001
LLPL/IV/QA/SOP/JHW-
Instrument IMM JH WELLTECH-260 Work Instruction 27/06/2021 22/06/2025 0
130/001
LLPL/IV/QA/SOP/JHW-
Instrument IMM JH WELLTECH-190 Work Instruction 27/06/2021 22/06/2025 0
130/001
LLPL/1V/QA/UCT/SOP/
Instrument Capping and labelling Machine Work Instruction 20/03/2021 15/03/2025 0
CL/001
LLPL/IV/QA/UCT/SOP/
Instrument pouch packaging Machine Work Instruction 20/03/2021 15/03/2025 0
PPKG/001
Doc. No. LST-QA-001
Levram Lifesciences Pvt. Ltd.
Effective Date 09-04-2023
Revision No. 00
Title- Master List of Documents
Page No. 14 of 14