weekly action plan 09 nov. to 14 nov.15

Weekly action plan QA Inspector

SEPTEMBER

No. Action3 4 5 6 7 8

DetailsMon Tue Wed Thu Fri Sat

1 VMP

HO

LID

AY

Revise VMP on the basis of PIC/S and ISPE guideüüü 50% complete

Planning and Schedule table (indicative only) üü To be done next week

2 HVAC

Modify the protocols on the basis of informatio üüü 80% complete

Make separate protocol for AHUs. üüü To be done next week

Make general validation protocol for HVAC system. üü To be done next week

If information available, make protocol for the major compone

SEPTEMBER

No. Action10 11 12 13 14 15


1 VMP

Revise VMP on the basis of PIC/S and ISPE guideüüü 70% complete

Planning and Schedule table (indicative only) üü To be done next week

Depends on the information provided by K. Tamaskar

2 HVAC

Modify the protocols on the basis of informatio üüMake separate protocol for AHUs. üüüü 80% complete

Make general validation protocol for HVAC system. üüü 50% complete

If information available, make protocol for the major components

SEPTEMBER

No. Action17 18 19 20 21 22


1 VMP

Revise VMP on the basis of PIC/S and ISPE guideüüü

HO

LID

AY

90% complete

Planning and Schedule table (indicative only) üü 50% complete

2 HVAC

Make separate protocol for AHUs. üüü 90%complete

Make general validation protocol for HVAC system. üü 90% complete




SEPTEMBER

No. Action24 25 26 27 28 29


1 VMP


Planning and Schedule table (indicative only)üüü

2 HVAC

Make separate protocol for AHUs. üüüMake general validation protocol for HVAC system.

üüüIf information available, make protocol for the major components

October

No. Action1 2 3 4 5 6


1 VMP

Complete the VMP for the pending topics üüü

HO

LID

AY

Computer system validation, SAT and information regarding utilities not done.

Equipment list completed for the new factory on the basis of information provided by K. Tamaskar

IQ protocol for AHU done but OQ pending

Done on the basis of information available. Information for major components not available.


Not complete. Studying GAMP5 for computer system validation.

Planning and Schedule table (indicative only) üü

HO

LID

AY

To be done next week

2 HVAC

Make OQ for AHUs üüüüü


October

No. Action8 9 10 11 12 13


1 VMP

Revise VMP on the basis of PIC/S and ISPE guideüüü Under progress

Planning and Schedule table (indicative only) üüü2 HVAC

Make OQ for AHUs üüü Under progress

üüüUnder progress

Collecting information and reference

Collect information regarding the major components of the HVAC system and about there qualification.

Collecting information and reference




October

No. Action15 16 17 18 19 20


1 VMP


HO

LID

AY

2 HVAC

Make OQ for AHUs üüü Under Progress

üü Under Progress


October

No. Action22 23 24 25 26 27


1 VMP

Revise VMP as per K.Wara comments and make aüüü

HO

LID

AY

2 HVAC




Make OQ for AHUs üüü

HO

LID

AY

üüIf information available, make protocol for the major compone

October/November

No. Action29 30 31 1 2 3


1 VMP

Prepare attachments for VMP üüü2 HVAC

Make OQ for AHUs üüüüüü


November

No. Action5 6 7 8 9 10


1 VMP






Make OQ for AHUs üüüüüü


November

No. Action12 13 14 15 16 17


1 VMP

Prepare attachments for VMP üüü

HO

LID

AY

2 HVAC

Make PQ for AHUs üüüüü






November

No. Action19 20 21 22 23 24


1 VMP


Make PQ for AHUs üüüüüü


December

No. Action10 11 12 13 14 15


1 VMP


Make PQ for AHUs üüüüüü





December

No. Action24 25 26 27 28 29


1 HVAC

Master Validation Plan for HVAC üüü

HO

LID

AY

Modification of AHU qualification as suggested üüüSOP for Enviromental Monitoring üü

Year 2013

January

No. Action7 8 9 10 11 12


1 HVAC

Master Validation Plan for HVAC üüüModification of AHU qualification as suggested during m üüüSOP for Enviromental Monitoring üü


January

No. Action14 15 16 17 18 19


1 HVAC


HO

LID

AY

Modification of AHU qualification as suggested during m üüSOP for Enviromental Monitoring üü

January

No. Action21 22 23 24 25 26


1 HVAC

Master Validation Plan for HVAC üüüüüü

January/February

No. Action28 29 30 31 1 2


1 HVAC


HO

LID

AY

Modification of AHU qualification as suggested during meeting with K.Tamaskar

üü

HO

LID

AY

PQ not complete yet

Coding of diffusers and return air outlets of the HVAC systemüüü

Have to revise again

February

No. Action11 12 13 14 15 16


1 HVAC


HO

LID

AY

üüCoding of diffusers and return air outlets of the HVAC system

üüü

February

No. Action18 19 20 21 22 23


1 HVAC

Master Validation Plan for HVAC üüüüüüüü

OQ/PQ of AHU as discussed during validation team meeting with K. Tamaskar

Revise the qualification test method in PQ of AHU

Collect data for the major components of HVAC from internetCoding of diffusers and return air outlets of the HVAC system

March

No. Action4 5 6 7 8 9


1 HVAC

Revising the Protocols for AHU according to c üüüüü

Revising Validation Master Plan üüü

March

No. Action11 12 13 14 15 16


1 HVAC

üüü HO

LIDAYRevising Validation Master Plan üü

March

No. Action18 19 20 21 22 23


1 HVAC

üüüRevising Validation Master Plan üüü

Collect data for the major components of HVAC from internet



2 Inspection of R&D laboratory ü

March

No. Action25 26 27 28 29 30


1 HVAC HO

LIDAY

üüüRevising Validation Master Plan üü

April

No. Action1 2 3 4 5 6


1 Validation project

ü üüRevising Validation Master Plan ü üü

2 ü3 ü4 ü

April

No. Action8 9 10 11 12 13


1 Validation project HO

LIDAY

üüRevising Validation Master Plan üü



Inspection of Sterile Manufacturing area (3rd floor)Inspection of Non Sterile Manufacturing area (2nd floor)Inspection of Non Sterile Manufacturing area (1st floor)


2 ü

HO

LIDAY

3 ü

April

No. Action22 23 24 25 26 27


1 HO

LIDAY

üü2 üü3 üNot complete yet

May

No. Action6 7 8 9 10 11


1 Revision of the HVAC validation protocol. üüü2 üü3 Studying BMS documents for the new factory. üü

May

No. Action13 14 15 16 17 18


1 Revision of the HVAC validation protocol. üüü Holiday2 Studying BMS documents for the new factory. üü

Inspection of Non Sterile Manufacturing area (2nd floor)Inspection of Non Sterile Manufacturing area (1st floor)

Coding of the return air and supply air outlets for the new factory.Checking of the online documents in both sterile and non sterile area.Inspection of the facility from maintenance point of view.

Inspection of the facility from maintenance point of view.

May

No. Action20 21 22 23 24 25


1 Revision of the HVAC validation protocol. üüü

Holiday

2 Studying BMS documents for the new factory. üüü3 üü

May Jun

No. Action27 28 29 30 31 1


1 Revision of the HVAC validation protocol. üüü2 Studying BMS documents for the new factory. üüü3 üüü

June

No. Action3 4 5 6 7 8


1 Revision of the HVAC validation protocol. üüü

Holiday

2 Studying BMS documents for the new factory. üü3 üüü

Studying validation documents of equipments for new factory



June

No. Action10 11 12 13 14 15


1 üüü2 üüü

June

No. Action17 18 19 20 21 22


1 üüü Holiday2 üü

No. Action24 25 26 27 28 29


1 üüü2 üüü

No. Action24 25 26 27 28 29


1 üüü2 üüü

JULY

Making validation protocols for GANSON machinesMaking validation protocols for CEMACH machines




No. Action1 2 3 4 5 6


1 Checking batch records üü Holiday2 üüü

JULY

No. Action8 9 10 11 12 13


1 üü2 üüüü

No. Action15 16 17 18 19 20


1 üüü2 üüü

No. Action22 23 24 25 26 27


1 Holiday

üü2 üüü

Making validation protocols for CEMACH machines

Making validation protocols for CEMACH machines

Revision of safety features pending

Making validation protocols for other GANSON machines

Revision of safety features of finished protocolsMaking validation protocols for other GANSON machines

Revision of safety features of finished protocolsMaking validation protocols for other GANSON machines

Protocols for other Ganson machine not done yet

July August

No. Action29 30 31 1 2 3


1 üüü Holiday

2 üü IQ GAC 800 completed

No. Action5 6 7 8 9 10


1 üüü GAC 800, HSMG 100L completed

2 üüü OQ not completed yet

No. Action12 13 14 15 16 17


1 Holiday

üü Holiday

HSMG 600L, U20

2 üü

No. Action19 20 21 22 23 24


Revision of protocols according to format in VMP

IQ of protocols completed, OQ still remaining

Making validation protocols for other GANSON machines

Making validation protocols for other GANSON machinesRevision of protocols according to format in VMP

Making validation protocols for other GANSON machinesRevision of protocols according to format in VMP

1 üüüüüü

No. Action26 27 28 29 30 31


1 üüüüüH

oliday

September

No. Action2 3 4 5 6 7


1 Inspection of manufacturing records üü2 üüüü

No. Action9 10 11 12 13 14


1 üüüüü

Holiday

No. Action16 17 18 19 20 21


Revision of protocols according to format as discussed in Validation team meeting.

Revision of protocols according to format as discussed in Validation team meeting.

Revision of Validation Records according to the discussion in Validation team meeting with K. Tamaskarn

Revision of Validation Protocols according to the discussion in Validation team meeting with K. Tamaskarn

Not completed as revised standard format was not available

1 üüüüü

Holiday

Ganscoater GAC 800 IQ completed

No. Action23 24 25 26 27 28


1 üüüüüü

Sept. October

No. Action30 1 2 3 4 5


1 üüüüüü

No. Action7 8 9 10 11 12


1 üüüüü

Holiday

No. Action14 15 16 17 18 19


1 üüüüüü

Revision of Validation Protocols according to the revised format.


Ganscoater GAC800 OQ, Ganscomminutor IQ/OQ completed


IQ/OQ Ganson Multimill, IQ/OQ Gansons VTS completed


IQ/OQ Ganson HSMG 100L, IQ/OQ Gansons HSMG 600L completed


IQ/OQ - Roll Compactor, SFT-500, Comil U20 completed

No. Action21 22 23 24 25 26


1 üü

Holiday üü

Holiday

October Nov.

No. Action28 29 30 31 1 2


1 Room and Equipment Coding for new facility üüüüüü

November

No. Action4 5 6 7 8 9


1 Room and Equipment Coding for new facility. üüü2 Perfomance Qualification of the Protocols üüü Not done yet

November

No. Action11 12 13 14 15 16


1 Room and Equipment Coding for new facility. üü Holiday


Room coding done on the basis of information available. Equipment coding pending

2 Perfomance Qualification of the Protocols üüü

Holiday

November

No. Action25 26 27 28 29 30


1 Perfomance Qualification of the Protocols üüüüüü Not getting suitable reference

December

No. Action2 3 4 5 6 7


1 Perfomance Qualification of the Protocols üüüH

oliday ü

Holiday

December

No. Action9 10 11 12 13 14


1 Perfomance Qualification of the Protocols üüüüüü

No. Action16 17 18 19 20 21


Not complete yet. Have to use other reference.


No. Action23 24 25 26 27 28



Not complete yet. Have to use other reference (Validation SOP Syed Imtiaz Haider)

Weekly action plan QA Inspector

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Year 2013

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks

Not finish yet

Not finish yet

Remarks

Remarks

Remarks

Remarks

IQ Sifter SFT-500 completed

Remarks

Remarks

Remarks

IQ/OQ for SFT-500, Multimill, Oblicon blender completed

Remarks

Remarks

Remarks

Remarks

Revising the protocols according to the revised protocol content according to VMP. Still requires 3 more working days

Remarks

Remarks

Remarks

Remarks

Time consumed in checking the batch records before final release

Remarks

Remarks

Remarks

Remarks

Remarks

JANUARY

No. Action13 14 15 16 17

Mon Tue Wed Thu Fri

1 Review of Manufacturing records ü ü ü2 üü

JANUARY

No. Action20 21 22 23 24

Mon Tue Wed Thu Fri

1 ü ü ü üü

JANUARY/FEBRUARY

No. Action27 28 29 30 31

Mon Tue Wed Thu Fri

1 ü ü2 ü üü

FEBRUARY

No. Action3 4 5 6 7

Mon Tue Wed Thu Fri

1 Revising attachments for VMP ü ü2 Study about Freeze Drier ü üü

FEBRUARY

No. Action17 18 19 20 21

Mon Tue Wed Thu Fri

1 IQ/OQ FBD600 ü ü ü2 IQ/OQ V-Blender600 üü

FEBRUARY/MARCH

No. Action24 25 26 27 28

Perfomance Qualification of the Protocols

Perfomance Qualification of the Protocols

Perfomance Qualification of the HSMG machineEquipment and Room Coding for new factory

No. ActionMon Tue Wed Thu Fri

1 Manufacturing records checking ü ü2 IQ/OQ V-Blender600 ü ü üü3 Room Coding üü

March

No. Action3 4 5 6 7

Mon Tue Wed Thu Fri

1 Room Coding ü ü ü2 Equipment list and Coding üü

March

No. Action10 11 12 13 14

Mon Tue Wed Thu Fri

1 Manufacturing records checking ü ü ü ü2 Room Coding ü

March

No. Action17 18 19 20 21

Mon Tue Wed Thu Fri

1 Manufacturing records checking ü ü2 Revise PQ of equipments ü ü üü

March

No. Action24 25 26 27 28

Mon Tue Wed Thu Fri

1 Manufacturing records checking ü ü2 Revise PQ of equipments ü ü üü

March/ April

No. Action31 1 2 3 4

Mon Tue Wed Thu Fri

1 Manufacturing records checking

HO

LIDA

Y

ü2 Revise PQ of equipments ü ü üü

April

No. Action7 8 9 10 11

Mon Tue Wed Thu Fri

1 Revise PQ of equipments ü ü ü üü

May

No. Action5 6 7 8 9

Mon Tue Wed Thu Fri

1 ü ü ü üü

May

No. Action12 13 14 15 16

Mon Tue Wed Thu Fri

1 Review manufacturing records ü ü ü üü2 ü ü ü üü

May

No. Action19 20 21 22 23

Mon Tue Wed Thu Fri

1 Revise PQ of GAC 800 ü ü2 ü ü üü

May

No. Action26 27 28 29 30

Mon Tue Wed Thu Fri

1 ü ü ü üü

Revise PQ of equipments as revised by K. Tamaskar

Revise PQ of equipments as revised by K. Tamaskar

Summarize and prepare attachments for QVMP


June

No. Action9 10 11 12 13

Mon Tue Wed Thu Fri

1 ü ü ü üü

June

No. Action16 17 18 19 20

Mon Tue Wed Thu Fri

1 ü ü2 Prepare pending PQ protocols ü üü

June

No. Action23 24 25 26 27

Mon Tue Wed Thu Fri

1 Check manufacturing records ü2 ü ü3 Prepare pending PQ protocols üü

June/July


Mon Tue Wed Thu Fri

1 Prepare pending PQ protocols ü ü ü üü

August

No. Action18 19 20 21 22

Mon Tue Wed Thu Fri

1 Prepare URS for all the protocols ü ü ü üü

Sept

No. Action8 9 10 11 12

Mon Tue Wed Thu Fri




1 Check Manufacturing documents ü ü2 Prepare URS for all the protocols ü üü

Sept

No. Action15 16 17 18 19

Mon Tue Wed Thu Fri

1 Check Manufacturing documents ü ü ü2 Prepare URS for all the protocols üü

Sept

No. Action22 23 24 25 26

Mon Tue Wed Thu Fri

1 Prepare URS for all the protocols ü ü ü üüSept/Oct

No. Action29 30 1 2 3

Mon Tue Wed Thu Fri

1 Prepare URS for all the protocols ü ü ü üü

Oct


Mon Tue Wed Thu Fri

1 ü ü ü üü2 Revise URS for all the protocols ü ü ü üü

Oct

No. Action13 14 15 16 17

Mon Tue Wed Thu Fri

1 ü ü ü üü

QA inpection for the preparation of GMP audit in November


2 Revise URS for all the protocols ü ü ü üü

Oct

No. Action20 21 22 23 24

Mon Tue Wed Thu Fri

1 Holid

ayü ü H

oliday

ü2 ü ü ü

Oct/Nov

No. Action27 28 29 30 31

Mon Tue Wed Thu Fri

1 ü ü üü2 ü3 ü ü ü üü

Nov

No. Action3 4 5 6 7

Mon Tue Wed Thu Fri

1 ü üü2 ü ü ü üü

Nov

No. Action10 11 12 13 14

Mon Tue Wed Thu Fri

1 ü üü2 ü ü ü üü

QA inpection for the preparation of GMP audit in NovemberRisk Assessment for Manfucaturing processes

QA inpection for the preparation of GMP audit in NovemberChecking Manufacturing documentsRisk Assessment for Manufacturing processes

QA inpection for the preparation of GMP audit in NovemberRisk Assessment for Manufacturing processes

QA inpection for the preparation of GMP audit in NovemberRisk Assessment for Manufacturing processes

Nov

No. Action24 25 26 27 28

Mon Tue Wed Thu Fri

1 ü ü üü2 Checking Manufacturing records ü3 ü ü üü

December

No. Action1 2 3 4 5

Mon Tue Wed Thu Fri

1 Checking Manufacturing records ü3 ü ü üü3 ü ü üü


Risk Assessment for Manufacturing processes

Risk Assessment for Manufacturing processesFollow up for the preparation of GMP audit

JANUARY18

Details RemarksSat

Holiday

JANUARY25

Details RemarksSat

ü Only HSMG M/C remaining

JANUARY/FEBRUARY1

Details RemarksSat

ü

FEBRUARY8

Details RemarksSat

HO

LIDAY

FEBRUARY22

Details RemarksSat

ü

FEBRUARY/MARCH1

Details Remarks

SatDetails Remarks

HO

LIDA

Y

March8

Details RemarksSat

ü

March15

Details RemarksSat

HO

LIDA

Y

March22

Details RemarksSat

ü

March29

Details RemarksSat

HO

LIDA

Y

March/ April

5Details Remarks

Sat

HO

LIDA

Y Making manufacturing record for Placebo which will cover most of the equipments.

April12

Details RemarksSat

Holid

ay

May10

Details RemarksSat

Holid

ay

May17

Details RemarksSat

Holid

ay

Ganscoater 800 remaining

May24

Details RemarksSat

Holid

ay

May31

Details RemarksSat

Holid

ay

June14

Details RemarksSat

Holid

ay

June21

Details RemarksSat

Holid

ay

June28

Details RemarksSat

Holid

ay

June/July5

Details RemarksSat

Holid

ay

August23

Details RemarksSat

Holid

ay

Sept13

Details RemarksSat

Not completed as had to check Manufacturing

records

Holid

ay

Sept20

Details RemarksSat

Holid

ay

Sept27

Details RemarksSat

Holid

ay

Sept/Oct4

Details RemarksSat

Holid

ay

Revsion Pending

Oct11

Details RemarksSat

Holid

ay

Oct18

Details RemarksSat

Holid

ay

VTS, Comil U20, Multimill, Ganscomminutor done

Holid

ay

Oct25

Details RemarksSat

Holid

ay

Oct/Nov1

Details RemarksSat

Holid

ay

Nov8

Details RemarksSat

Holid

ay

Nov15

Details RemarksSat

Holid

ay

Nov29

Details RemarksSat

Holid

ay

December6

Details RemarksSat

Holid

ay

January

No. Action5 6 7 8

Mon Tue Wed Thu

1 ü ü ü ü

January

No. Action12 13 14 15

Mon Tue Wed Thu

1 ü ü ü2 ü

January

No. Action19 20 21 22

Mon Tue Wed Thu

1

2 Verify drains of each room ü ü3 ü ü

January

No. Action26 27 28 29

Mon Tue Wed Thu

1

2 ü ü3 ü ü

Feb

No. Action2 3 4 5

Verifying Certificates and Documents of Neela Water System

Verify Certificates and Documents of Neela Water SystemVerify GA drawing of the equipments

Verify GA drawing of the equipments

Prepare Room label with both new and old coding

Verify GA drawing of the equipmentsUser Point Verification of Sterile Side for PW, WFI and PSGVerify the rooms from METECNO drawing.

No. ActionMon Tue Wed Thu

1 ü2 ü ü ü

Feb

No. Action9 10 11 12

Mon Tue Wed Thu

1 ü ü ü ü

March

No. Action2 3 4 5

Mon Tue Wed Thu

1 ü ü Holid

ay

2 ü

March


Mon Tue Wed Thu

1 ü ü2 ü ü

March

No. Action16 17 18 19

Mon Tue Wed Thu

1 ü ü ü2 ü

Verify GA drawing of the equipmentsUser Point Verification of Sterile Side for PW, WFI and PSG


Compile Utility requirement for all the equipments


Verify GA drawing of the equipmentsDismantle all the rejected valves(Neela Water System) and supervise there proper packing.

Verify GA drawing of the equipmentsVerify the opening for the Supply air and Return as per drawing.

March

No. Action16 17 18 19

Mon Tue Wed Thu

1 ü ü ü2 ü

March

No. Action24 25 26 27

Mon Tue Wed Thu

1 ü ü ü2 ü

March/ April

No. Action30 31 1 2

Mon Tue Wed Thu

1 ü ü ü ü

April

No. Action6 7 8 9

Mon Tue Wed Thu

1 ü ü ü ü

April

No. Action20 21 22 23

Mon Tue Wed Thu

1 ü ü ü ü



Verify the opening for the Supply air and Return as per drawing.

Verify the switches and conduits against the drawing


May

No. Action4 5 6 7

Mon Tue Wed Thu

1 ü ü ü2 ü

May

No. Action11 12 13 14

Mon Tue Wed Thu

1 ü ü ü2 ü

May

No. Action18 19 20 21

Mon Tue Wed Thu

1 ü ü ü

2 ü

May

No. Action25 26 27 28

Mon Tue Wed Thu

1 ü ü ü

Measure the position of the drains in each room and put it on drawing.


Measure the position of the drains in each room and put it on drawing.

Verify the switches, conduits and lighting marks against the drawing

Measure the position of the drains in each room and put it on drawing.Verify all the received machines against the packing list and assign room number to them for shifting

Verify compressed air points for process areas against the plan provided by Khun Tamaskar.

2 ü

June

No. Action1 2 3 4

Mon Tue Wed Thu

1 ü ü ü ü

June

No. Action8 9 10 11

Mon Tue Wed Thu

1 ü ü ü ü

June

No. Action15 16 17 18

Mon Tue Wed Thu

1 ü ü ü ü2 ü ü ü ü

June/ July

No. Action29 30 1 2

Mon Tue Wed Thu

1 ü ü ü ü

July

No. Action6 7 8 9

Mon Tue Wed Thu

Follow up and verify the modified marking for accomodating the lighting panels.

Remove rejected NEELA valves and there packing

Remove rejected NEELA valves and there packing

Check and Verify the Machine Transfer in the processing areasRemove rejected NEELA valves and there packing

Doing impact assessment for the machines

1 ü ü ü ü

July

No. Action13 14 15 16

Mon Tue Wed Thu

1 Working with K Tamaskar ü ü ü ü

2 ü ü ü ü

July

No. Action20 21 22 23

Mon Tue Wed Thu

1 ü ü ü ü

July/August

No. Action27 28 29 30

Mon Tue Wed Thu

1 ü ü ü

Holid

ay

August

No. Action3 4 5 6

Mon Tue Wed Thu

1 ü ü ü

2 ü





Incorporating risk assessment in the Validation Protocol where ever possibleRevising room numbering of the plant on the basis of as built status.

August

No. Action10 11 12 13

Mon Tue Wed Thu

1 Working with Khun Tamaskar ü üH

oliday ü

August

No. Action17 18 19 20

Mon Tue Wed Thu

1

Holid

ay2 ü ü3 ü

August

No. Action24 25 26 27

Mon Tue Wed Thu

1 ü ü ü ü

August/ September

No. Action31 1 2 3

Mon Tue Wed Thu

1

Holid

ay

ü

2 ü ü

Revising room numbering of the plant on the basis of as built status.Make separate autocad drawing for normal and steam condensate drain.Make line diagram for PW, WFI and PSG and add new User Points.

Incorporating risk assessment in the Validation Protocol where ever possible

Incorporating risk assessment in the Validation Protocol where ever possibleWorking with Mr. Tamaskar and taking follow up of the remaining jobs

September

No. Action7 8 9 10

Mon Tue Wed Thu

1 ü ü

2 ü ü

3 ü ü

September

No. Action14 15 16 17

Mon Tue Wed Thu

1 ü ü ü ü2 ü ü ü ü

September

No. Action22 23 24 25

Mon Tue Wed Thu

1 ü ü ü ü

September/ October


Mon Tue Wed Thu

1 ü ü ü ü

Marking position for the installation of Passbox

Incorporating risk assessment in the Validation Protocol where ever possible

Working with Mr. Tamaskar and taking follow up of the remaining jobs

Follow up of the work in progress in plant.Incorporating risk assessment in the Validation Protocol where ever possible

Verification of the installation of Return double wall, switch, plug, smoke detector and light fittings in Non Sterile area

Working with K. Tamaskar and follow up

2 Installation of Passbox ü

3 ü ü ü

October

No. Action5 6 7 8

Mon Tue Wed Thu

1 ü2

3 ü ü

4 ü

October

No. Action12 13 14 15

Mon Tue Wed Thu

1 ü ü2

3 ü

4 ü ü ü

October

No. Action19 20 21 22

Verification of the removable panel

Discuss QC utility Requirements with Khu PunnadaShift Autoclaves according to final drawingVerify position of the new process drains with techniciansDiscuss drawing for installation of new process drains with Khun Thep

Make LBS utility requirement as per room detailShift Autoclaves according to final drawingVerify position of the new process drains with techniciansFollow up of the installation of return panel for HVAC and installation of Passbox

No. ActionMon Tue Wed Thu

1 ü ü ü ü2

October

No. Action26 27 28 29

Mon Tue Wed Thu

1 ü ü ü ü

November

No. Action2 3 4 5

Mon Tue Wed Thu

1 ü ü ü ü

November


Mon Tue Wed Thu

1 ü ü ü ü2 Passbox Installation ü ü

Follow up of the work by Metechno contractorShift Autoclaves according to final drawing

Follow up of the work by Metechno contractor

Follow up of the work by Metechno contractor and working with Mr. Tamaskar.

Follow up of the work by Metechno contractor.

January9 10

Details RemarksFri Sat

ü

Holid

ay

January16 17


Holid

ayü

January23 24


ü ü

January30 31


ü ü

Feb6 7

Details Remarks

Fri SatDetails Remarks

ü üSome points not clear from drawing

Feb13 14


ü

Holid

ay

March6 7


Holid

ay

ü

March13 14


ü ü

March20 21


Holid

ayü

Cannot continue as Metecno person were cutting panels in the room

Made the list already but cannot dimantle. Waiting for confirmation from Khun Lheela

March20 21


Holid

ayü

March28 29


ü ü

March/ April3 4


üH

oliday

April10 11


ü ü

April24 25


ü ü

FBD and Ganscoater complete

Non Sterile side complete, Sterile side waiting for revised drawing from Airflow for return and supply.

Flooring work under progress so unable to assess all the corridors

May8 9


Holid

ayü

May15 16


ü ü

May22 23


ü ü

May29 30


Holid

ay

Work not complete as flooring work under

progress

Incomplete as flooring work in sterile area under progress

Changed Saturday Holiday

ü

Holid

ay

June5 6


ü

Holid

ay

June12 13


ü ü

June19 20


ü Holid

ay

ü

June/ July3 4


ü

Holid

ay

Collecting Information

July10 11


Packing material not sufficient.

Non Sterile Side complete, Sterile Side some rooms remaining.

ü

Holid

ay

July17 18


ü ü

ü ü

July24 25


ü ü Not finished yet

July/August31 1


üH

oliday

August7 8


ü

Holid

ay

Not done as working with Klenzaids Engineer for Ampoule tunnel line for whole week

August14 15


ü ü

August21 22


ü ü

ü

August28 29


üH

oliday

August/ September4 5


ü ü

Wed- Go to Immigration for transferring Visa in new passport

Working on Freeze Drier

31 Aug- Went to immigration for making yearly VISA

September11 12


Holid

ay

ü

September18 19


ü ü

ü ü

September26 27


ü

Holid

ay

September/ October2 3


ü ü

Risk Assessment not done as was busy in transferring equipments in rooms.

October9 10


Holid

ay

ü Technicians not free

ü

October16 17


ü ü Technician not available

ü

October23 24

Details Remarks

Marking on the panels done to accommodate

Passbox

Waiting for Khun Thep to assign job to

Technician

Waiting for Khun Thep to assign job to technician

Fri SatDetails Remarks

ü üü ü

October30 31


ü

Holid

ay

November6 7


ü ü

November13 14


ü Holid

ay