ACTION PLAN FOR QMS IMPLIMENTATION

Expected Date of
Sl.No DEPARTMENT DOCUMENT NAME
Completion
SOPs 31.03.2023
SMF 31.05.2023
VMP 31.05.2023
1 QA
QMS Completed
Internal Audit Shedule 15.04.2023
Log books related to SOP 31.03.2023
SOPs
Method validation
Instrument Qualification
Temperature Mapping
Calibration Schedule
Job Discription,Analyst Qualification &
Training Record
Control Sample+ Storage+Distruction
2 QC Reference / Working Standard
(List,Qualification,Reconciliation)
Temperature and Humidity Record
Availability/Stand-by/Calibration of
Standard weight Box
Calibration of Measuring Equipments
Column Usage/Performance Log
Data Back-up
List Authorized Persons to enter QC
Log books related to SOP
SOPs
Reactors volumetric calibration
Process Validation
Equipment Hold time Study
(dirty-hold time, clean-hold time)
Filter bag Change Record
3 Production Equipmment Status Board
Production Weighing Balance check
(Daily, Fortnightly, Quartterly, half
yearly and Yearly)
Job Discription.
Training Record of Individual employee
Log books related to SOP
SOPs
Equipment Qualification
Utilities Qualification
Preventive Maintenance shedule
Calibration Shedule
4 Engineering
4 Engineering
Approved Drawings
Light fittings number
SAG, RAG Number
Under ground water tank Number
Log books related to SOP
SOPs
Training shedule
Training Calender
Training Need identification
Individule Personnel File
Pest Control and Lay out
(Gum Pad and Rodent bite station)
Insectocutor/ Fly catcher lay out
Job Discription of Individuals,
5 HR Possition wise & Key Personnels
HR Poloicies
Induction Program
Organogram
Exit Interview
Distribution of Uniforms and Aprons
record
Master Role
Specimen Signature
Log books related to SOP
SOPs
Fire Hydrant Layout Drawing
Fire Extinguisher Layout drawing
Emergency evaccuation Plan
Fire Hydrant Challenging Test
6 Safety Smoke detector & Foam dispenser
Numbering
Numbering And Layout drawing for
fire extinguisher
Hose reel Box Number
Safety Instructions for material Hoist
Log books related to SOP
SOPs
Gum pads and Rodent Bite Station
7 Warehouse
Temperature Mapping
Log books related to SOP
 Name of the
S. No. Equipment / Code
Instrument
Equipments
1          Reactor R
2          Dosing tank DT
3          Vacuum tray drier VTD
Roto cone vacuum
4          RCVD
drier
5          Centrifuge CF
6          Storage tank ST
7          Holding Tank HT
8          Nutsche filter NF
9          Blender BL
10      Multi mill MM
11      Sifter SFT
12      Microniser MN
13      Sparkler Filter SPF
14      Dome Filter DF
15      Micron Filter MF
Equipment code
16      Vacuum trap
with VT
Equipment code
17      Vacuum Pump
with VP
Equipment code
18      Receiver
with RE
Equipment code
19      Condenser
with HE
20      Air curtain PR/ACR
Environmental
21      EVM
monitor
22      Lights PRLT
23      Smoke detector PRSD
24      Fire siren PRFS
25      Isolator module PRISM
26      Camera PRCAM
27      Safety shower PRSS
28      Light switch PRLTS
29      Single phase PR 1Ø
30      Three phase PR 3Ø
Breathing
31      PRBA
apparatus
32      Push button PRPB
33      Compound gauge CG
34      Temperature gauge TG
Temperature
35      TS
sensor
Temperature
36      TI
indicator
37      Vacuum gauge VG
38      Pressure gauge PG
 EQUIPMENT QUALIFICATION

Sl.No Equipment Name Resposibility URS DQP DQR IQP

1 Reactor
2 Vacuum tray drier
3 Roto cone vacuum drier
4 Centrifuge
5 Nutsche filter

Manjunath
6 Blender
7 Multi mill
8 Sifter
9 Microniser
10 Sparkler Filter
11 Dome Filter
12 Micron Filter

UTILITY QUALIFICATION

Sl.No Equipment Name Resposibility URS DQP DQR IQP

1 Air Compressor
2 Steam Boiler
3 Chilled Brine Unit
4 Chilled Water Unit
5 Cooling tower
6 Diesel Generator
Manjunath

7 Hot Water Unit

8 Scrubber
9 Thermic fluid heater
10 Vacuum Pump
11 Air Handling Unit
12 Exhaust Unit
13 Fire-Hydrant System
14 Fire-Alarm System
CATION

IQR OQP OQR PQP PQR

ATION

IQR OQP OQR PQP PQR