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
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
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
If information available, make protocol for the major compone
Depends on the information provided by K. Tamaskar
Depends on the information provided by K. Tamaskar
SEPTEMBER
No. Action24 25 26 27 28 29
DetailsMon Tue Wed Thu Fri Sat
1 VMP
Revise VMP on the basis of PIC/S and ISPE guideüüü
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
DetailsMon Tue Wed Thu Fri Sat
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.
Depends on the information provided by K. Tamaskar
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
If information available, make protocol for the major compone
October
No. Action8 9 10 11 12 13
DetailsMon Tue Wed Thu Fri Sat
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
Depends on the information provided by K. Tamaskar
Collect information regarding the major components of the HVAC system and about there qualification.
If information available, make protocol for the major components
October
No. Action15 16 17 18 19 20
DetailsMon Tue Wed Thu Fri Sat
1 VMP
Revise VMP on the basis of PIC/S and ISPE guideüüü
HO
LID
AY
2 HVAC
Make OQ for AHUs üüü Under Progress
üü Under Progress
If information available, make protocol for the major compone
October
No. Action22 23 24 25 26 27
DetailsMon Tue Wed Thu Fri Sat
1 VMP
Revise VMP as per K.Wara comments and make aüüü
HO
LID
AY
2 HVAC
Depends on the information provided by K. Tamaskar
Collect information regarding the major components of the HVAC system and about there qualification.
Depends on the information provided by K. Tamaskar
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
DetailsMon Tue Wed Thu Fri Sat
1 VMP
Prepare attachments for VMP üüü2 HVAC
Make OQ for AHUs üüüüüü
If information available, make protocol for the major components
November
No. Action5 6 7 8 9 10
DetailsMon Tue Wed Thu Fri Sat
1 VMP
Collect information regarding the major components of the HVAC system and about there qualification.
Depends on the information provided by K. Tamaskar
Collect information regarding the major components of the HVAC system and about there qualification.
Depends on the information provided by K. Tamaskar
Prepare attachments for VMP üüü2 HVAC
Make OQ for AHUs üüüüüü
If information available, make protocol for the major components
November
No. Action12 13 14 15 16 17
DetailsMon Tue Wed Thu Fri Sat
1 VMP
Prepare attachments for VMP üüü
HO
LID
AY
2 HVAC
Make PQ for AHUs üüüüü
If information available, make protocol for the major compone
Collect information regarding the major components of the HVAC system and about there qualification.
Depends on the information provided by K. Tamaskar
Collect information regarding the major components of the HVAC system and about there qualification.
Depends on the information provided by K. Tamaskar
November
No. Action19 20 21 22 23 24
DetailsMon Tue Wed Thu Fri Sat
1 VMP
Prepare attachments for VMP üüü2 HVAC
Make PQ for AHUs üüüüüü
If information available, make protocol for the major components
December
No. Action10 11 12 13 14 15
DetailsMon Tue Wed Thu Fri Sat
1 VMP
Prepare attachments for VMP üüü2 HVAC
Make PQ for AHUs üüüüüü
Collect information regarding the major components of the HVAC system and about there qualification.
Depends on the information provided by K. Tamaskar
Collect information regarding the major components of the HVAC system and about there qualification.
If information available, make protocol for the major components
December
No. Action24 25 26 27 28 29
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
1 HVAC
Master Validation Plan for HVAC üüüModification of AHU qualification as suggested during m üüüSOP for Enviromental Monitoring üü
Depends on the information provided by K. Tamaskar
January
No. Action14 15 16 17 18 19
DetailsMon Tue Wed Thu Fri Sat
1 HVAC
Master Validation Plan for HVAC üüü
HO
LID
AY
Modification of AHU qualification as suggested during m üüSOP for Enviromental Monitoring üü
January
No. Action21 22 23 24 25 26
DetailsMon Tue Wed Thu Fri Sat
1 HVAC
Master Validation Plan for HVAC üüüüüü
January/February
No. Action28 29 30 31 1 2
DetailsMon Tue Wed Thu Fri Sat
1 HVAC
Master Validation Plan for HVAC üüü
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
DetailsMon Tue Wed Thu Fri Sat
1 HVAC
Master Validation Plan for HVAC üüü
HO
LID
AY
üüCoding of diffusers and return air outlets of the HVAC system
üüü
February
No. Action18 19 20 21 22 23
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
1 HVAC
Revising the Protocols for AHU according to c üüüüü
Revising Validation Master Plan üüü
March
No. Action11 12 13 14 15 16
DetailsMon Tue Wed Thu Fri Sat
1 HVAC
üüü HO
LIDAYRevising Validation Master Plan üü
March
No. Action18 19 20 21 22 23
DetailsMon Tue Wed Thu Fri Sat
1 HVAC
üüüRevising Validation Master Plan üüü
Collect data for the major components of HVAC from internet
Collect data for the major components of HVAC from internet
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
DetailsMon Tue Wed Thu Fri Sat
1 HVAC HO
LIDAY
üüüRevising Validation Master Plan üü
April
No. Action1 2 3 4 5 6
DetailsMon Tue Wed Thu Fri Sat
1 Validation project
ü üüRevising Validation Master Plan ü üü
2 ü3 ü4 ü
April
No. Action8 9 10 11 12 13
DetailsMon Tue Wed Thu Fri Sat
1 Validation project HO
LIDAY
üüRevising Validation Master Plan üü
Collect data for the major components of HVAC from internet
Collect data for the major components of HVAC from internet
Inspection of Sterile Manufacturing area (3rd floor)Inspection of Non Sterile Manufacturing area (2nd floor)Inspection of Non Sterile Manufacturing area (1st floor)
Collect data for the major components of HVAC from internet
2 ü
HO
LIDAY
3 ü
April
No. Action22 23 24 25 26 27
DetailsMon Tue Wed Thu Fri Sat
1 HO
LIDAY
üü2 üü3 üNot complete yet
May
No. Action6 7 8 9 10 11
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
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
Studying validation documents of equipments for new factory
Studying validation documents of equipments for new factory
June
No. Action10 11 12 13 14 15
DetailsMon Tue Wed Thu Fri Sat
1 üüü2 üüü
June
No. Action17 18 19 20 21 22
DetailsMon Tue Wed Thu Fri Sat
1 üüü Holiday2 üü
No. Action24 25 26 27 28 29
DetailsMon Tue Wed Thu Fri Sat
1 üüü2 üüü
No. Action24 25 26 27 28 29
DetailsMon Tue Wed Thu Fri Sat
1 üüü2 üüü
JULY
Making validation protocols for GANSON machinesMaking validation protocols for CEMACH machines
Making validation protocols for GANSON machinesMaking validation protocols for CEMACH machines
Making validation protocols for GANSON machinesMaking validation protocols for CEMACH machines
Making validation protocols for GANSON machinesMaking validation protocols for CEMACH machines
No. Action1 2 3 4 5 6
DetailsMon Tue Wed Thu Fri Sat
1 Checking batch records üü Holiday2 üüü
JULY
No. Action8 9 10 11 12 13
DetailsMon Tue Wed Thu Fri Sat
1 üü2 üüüü
No. Action15 16 17 18 19 20
DetailsMon Tue Wed Thu Fri Sat
1 üüü2 üüü
No. Action22 23 24 25 26 27
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
1 üüü Holiday
2 üü IQ GAC 800 completed
No. Action5 6 7 8 9 10
DetailsMon Tue Wed Thu Fri Sat
1 üüü GAC 800, HSMG 100L completed
2 üüü OQ not completed yet
No. Action12 13 14 15 16 17
DetailsMon Tue Wed Thu Fri Sat
1 Holiday
üü Holiday
HSMG 600L, U20
2 üü
No. Action19 20 21 22 23 24
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
1 üüüüüH
oliday
September
No. Action2 3 4 5 6 7
DetailsMon Tue Wed Thu Fri Sat
1 Inspection of manufacturing records üü2 üüüü
No. Action9 10 11 12 13 14
DetailsMon Tue Wed Thu Fri Sat
1 üüüüü
Holiday
No. Action16 17 18 19 20 21
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
1 üüüüüü
Sept. October
No. Action30 1 2 3 4 5
DetailsMon Tue Wed Thu Fri Sat
1 üüüüüü
No. Action7 8 9 10 11 12
DetailsMon Tue Wed Thu Fri Sat
1 üüüüü
Holiday
No. Action14 15 16 17 18 19
DetailsMon Tue Wed Thu Fri Sat
1 üüüüüü
Revision of Validation Protocols according to the revised format.
Revision of Validation Protocols according to the revised format.
Ganscoater GAC800 OQ, Ganscomminutor IQ/OQ completed
Revision of Validation Protocols according to the revised format.
IQ/OQ Ganson Multimill, IQ/OQ Gansons VTS completed
Revision of Validation Protocols according to the revised format.
IQ/OQ Ganson HSMG 100L, IQ/OQ Gansons HSMG 600L completed
Revision of Validation Protocols according to the revised format.
IQ/OQ - Roll Compactor, SFT-500, Comil U20 completed
No. Action21 22 23 24 25 26
DetailsMon Tue Wed Thu Fri Sat
1 üü
Holiday üü
Holiday
October Nov.
No. Action28 29 30 31 1 2
DetailsMon Tue Wed Thu Fri Sat
1 Room and Equipment Coding for new facility üüüüüü
November
No. Action4 5 6 7 8 9
DetailsMon Tue Wed Thu Fri Sat
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
DetailsMon Tue Wed Thu Fri Sat
1 Room and Equipment Coding for new facility. üü Holiday
Revision of Validation Protocols according to the revised format.
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
DetailsMon Tue Wed Thu Fri Sat
1 Perfomance Qualification of the Protocols üüüüüü Not getting suitable reference
December
No. Action2 3 4 5 6 7
DetailsMon Tue Wed Thu Fri Sat
1 Perfomance Qualification of the Protocols üüüH
oliday ü
Holiday
December
No. Action9 10 11 12 13 14
DetailsMon Tue Wed Thu Fri Sat
1 Perfomance Qualification of the Protocols üüüüüü
No. Action16 17 18 19 20 21
DetailsMon Tue Wed Thu Fri Sat
Not complete yet. Have to use other reference.
1 Perfomance Qualification of the Protocols üüüüüü
No. Action23 24 25 26 27 28
DetailsMon Tue Wed Thu Fri Sat
1 Perfomance Qualification of the Protocols üüüüüü
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
Remarks
Remarks
Year 2013
Remarks
Remarks
Remarks
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
Remarks
Remarks
Remarks
Remarks
Remarks
Remarks
Remarks
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
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
No. Action30 1 2 3 4
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
Summarize and prepare attachments for QVMP
Summarize and prepare attachments for QVMP
Summarize and prepare attachments for QVMP
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
No. Action6 7 8 9 10
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
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
QA inpection for the preparation of GMP audit in November
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
No. Action9 10 11 12
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
Verify GA drawing of the equipments
Compile Utility requirement for all the equipments
Verify GA drawing of 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 GA drawing of the equipmentsVerify the opening for the Supply air and Return as per drawing.
Verify GA drawing of the equipmentsVerify the opening for the Supply air and Return as per drawing.
Verify the opening for the Supply air and Return as per drawing.
Verify the switches and conduits against the 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.
Verify the switches and conduits against the 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
Doing impact assessment for the machines
Doing impact assessment for the machines
Doing impact assessment for the machines
Doing impact assessment for the machines
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
No. Action28 29 30 1
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
No. Action9 10 11 12
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
Details RemarksFri Sat
Holid
ayü
January23 24
Details RemarksFri Sat
ü ü
January30 31
Details RemarksFri Sat
ü ü
Feb6 7
Details Remarks
Fri SatDetails Remarks
ü üSome points not clear from drawing
Feb13 14
Details RemarksFri Sat
ü
Holid
ay
March6 7
Details RemarksFri Sat
Holid
ay
ü
March13 14
Details RemarksFri Sat
ü ü
March20 21
Details RemarksFri Sat
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
Details RemarksFri Sat
Holid
ayü
March28 29
Details RemarksFri Sat
ü ü
March/ April3 4
Details RemarksFri Sat
üH
oliday
April10 11
Details RemarksFri Sat
ü ü
April24 25
Details RemarksFri Sat
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
Details RemarksFri Sat
Holid
ayü
May15 16
Details RemarksFri Sat
ü ü
May22 23
Details RemarksFri Sat
ü ü
May29 30
Details RemarksFri Sat
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
Details RemarksFri Sat
ü
Holid
ay
June12 13
Details RemarksFri Sat
ü ü
June19 20
Details RemarksFri Sat
ü Holid
ay
ü
June/ July3 4
Details RemarksFri Sat
ü
Holid
ay
Collecting Information
July10 11
Details RemarksFri Sat
Packing material not sufficient.
Non Sterile Side complete, Sterile Side some rooms remaining.
ü
Holid
ay
July17 18
Details RemarksFri Sat
ü ü
ü ü
July24 25
Details RemarksFri Sat
ü ü Not finished yet
July/August31 1
Details RemarksFri Sat
üH
oliday
August7 8
Details RemarksFri Sat
ü
Holid
ay
Not done as working with Klenzaids Engineer for Ampoule tunnel line for whole week
August14 15
Details RemarksFri Sat
ü ü
August21 22
Details RemarksFri Sat
ü ü
ü
August28 29
Details RemarksFri Sat
üH
oliday
August/ September4 5
Details RemarksFri Sat
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
Details RemarksFri Sat
Holid
ay
ü
September18 19
Details RemarksFri Sat
ü ü
ü ü
September26 27
Details RemarksFri Sat
ü
Holid
ay
September/ October2 3
Details RemarksFri Sat
ü ü
Risk Assessment not done as was busy in transferring equipments in rooms.
October9 10
Details RemarksFri Sat
Holid
ay
ü Technicians not free
ü
October16 17
Details RemarksFri Sat
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
Details RemarksFri Sat
ü
Holid
ay
November6 7
Details RemarksFri Sat
ü ü
November13 14
Details RemarksFri Sat
ü Holid
ay
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