Weekly action plan QA Inspector

SEPTEMBER
3 4 5 6 7 8
No. Action Mon Tue Wed Thu Fri Sat

1 VMP

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

Planning and Schedule table (indicative only)

HOLIDAY
2 HVAC

Modify the protocols on the basis of information provided by K.

Make separate protocol for AHUs.
Make general validation protocol for HVAC system.
If information available, make protocol for the major components of the HVAC syste

SEPTEMBER
10 11 12 13 14 15
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

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

Planning and Schedule table (indicative only)
 2 HVAC

Modify the protocols on the basis of information provided by K.

Make separate protocol for AHUs.
Make general validation protocol for HVAC system.
If information available, make protocol for the major components of the HVAC system.

SEPTEMBER
17 18 19 20 21 22
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

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

Planning and Schedule table (indicative only)

HOLIDAY
2 HVAC

Make separate protocol for AHUs.

Make general validation protocol for HVAC system.
If information available, make protocol for the major components of the HVAC syste
 SEPTEMBER
24 25 26 27 28 29
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

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

Planning and Schedule table (indicative only)

2 HVAC

Make separate protocol for AHUs.

Make general validation protocol for HVAC system.

If information available, make protocol for the major components of the HVAC system.

October
1 2 3 4 5 6
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

Complete the VMP for the pending topics

LIDAY
 Planning and Schedule table (indicative only)

HOLIDAY
2 HVAC

Make OQ for AHUs

Collect information regarding the major components of the
HVAC system and about there qualification.
If information available, make protocol for the major components of the HVAC syste

October
8 9 10 11 12 13
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

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

Planning and Schedule table (indicative only)
2 HVAC

Make OQ for AHUs

Collect information regarding the major components of the
HVAC system and about there qualification.
 If information available, make protocol for the major components of the HVAC system.

October
15 16 17 18 19 20
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

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

2 HVAC

HOLIDAY
Make OQ for AHUs
Collect information regarding the major components of the
HVAC system and about there qualification.
If information available, make protocol for the major components of the HVAC syste

October
22 23 24 25 26 27
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

Revise VMP as per K.Wara comments and make attachment lis

2 HVAC

HOLIDAY
 HOLIDAY
Make OQ for AHUs
Collect information regarding the major components of the
HVAC system and about there qualification.
If information available, make protocol for the major components of the HVAC syste

October/November
29 30 31 1 2 3
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

Prepare attachments for VMP

2 HVAC

Make OQ for AHUs

Collect information regarding the major components of the
HVAC system and about there qualification.
If information available, make protocol for the major components of the HVAC system.

November
5 6 7 8 9 10
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP
 Prepare attachments for VMP
2 HVAC

Make OQ for AHUs

Collect information regarding the major components of the
HVAC system and about there qualification.
If information available, make protocol for the major components of the HVAC system.

November
12 13 14 15 16 17
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

Prepare attachments for VMP

2 HVAC

HOLIDAY
Make PQ for AHUs
Collect information regarding the major components of the
HVAC system and about there qualification.
If information available, make protocol for the major components of the HVAC syste
 November
19 20 21 22 23 24
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

Prepare attachments for VMP

2 HVAC

Make PQ for AHUs

Collect information regarding the major components of the
HVAC system and about there qualification.
If information available, make protocol for the major components of the HVAC system.

December
10 11 12 13 14 15
No. Action
Mon Tue Wed Thu Fri Sat

1 VMP

Prepare attachments for VMP

2 HVAC

Make PQ for AHUs

Collect information regarding the major components of the
HVAC system and about there qualification.
 If information available, make protocol for the major components of the HVAC system.

December
24 25 26 27 28 29
No. Action
Mon Tue Wed Thu Fri Sat

1 HVAC

Master Validation Plan for HVAC

HOLIDAY
Modification of AHU qualification as suggested during meeting
SOP for Enviromental Monitoring
Year 2013

January
7 8 9 10 11 12
No. Action
Mon Tue Wed Thu Fri Sat

1 HVAC

Master Validation Plan for HVAC

Modification of AHU qualification as suggested during meeting with K.Tamas
SOP for Enviromental Monitoring
 January
14 15 16 17 18 19
No. Action
Mon Tue Wed Thu Fri Sat

1 HVAC

Master Validation Plan for HVAC

HOLIDAY
Modification of AHU qualification as suggested during meeting with K.Tamas
SOP for Enviromental Monitoring
January
21 22 23 24 25 26
No. Action
Mon Tue Wed Thu Fri Sat

1 HVAC

Master Validation Plan for HVAC

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

January/February
28 29 30 31 1 2
No. Action
Mon Tue Wed Thu Fri Sat

1 HVAC

Master Validation Plan for HVAC

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

Coding of diffusers and return air outlets of the HVAC system
February
11 12 13 14 15 16
No. Action
Mon Tue Wed Thu Fri Sat

1 HVAC

Master Validation Plan for HVAC

HOLIDAY
Revise the qualification test method in PQ of AHU
Coding of diffusers and return air outlets of the HVAC system
February
18 19 20 21 22 23
No. Action
Mon Tue Wed Thu Fri Sat

1 HVAC

Master Validation Plan for HVAC

Collect data for the major components of HVAC from internet
Coding of diffusers and return air outlets of the HVAC system
 March
4 5 6 7 8 9
No. Action
Mon Tue Wed Thu Fri Sat

1 HVAC

Revising the Protocols for AHU according to comments from K.

Collect data for the major components of HVAC from internet
Revising Validation Master Plan
March
11 12 13 14 15 16
No. Action
Mon Tue Wed Thu Fri Sat

1 HVAC

Collect data for the major components of HVAC from internet

HOLIDAY
Revising Validation Master Plan
March
18 19 20 21 22 23
No. Action
Mon Tue Wed Thu Fri Sat
1 HVAC
Collect data for the major components of HVAC from internet
Revising Validation Master Plan
2 Inspection of R&D laboratory
March
25 26 27 28 29 30
No. Action
Mon Tue Wed Thu Fri Sat
1 HVAC

HOLIDAY
Collect data for the major components of HVAC from internet
Revising Validation Master Plan
April
1 2 3 4 5 6
No. Action
Mon Tue Wed Thu Fri Sat

1 Validation project
Collect data for the major components of HVAC from internet
Revising Validation Master Plan
2 Inspection of Sterile Manufacturing area (3rd floor)
3 Inspection of Non Sterile Manufacturing area (2nd floor)
4 Inspection of Non Sterile Manufacturing area (1st floor)
April
8 9 10 11 12 13
No. Action
Mon Tue Wed Thu Fri Sat

1 Validation project
Collect data for the major components of HVAC from internet

HOLIDAY
Revising Validation Master Plan
 HOLIDAY
2 Inspection of Non Sterile Manufacturing area (2nd floor)
3 Inspection of Non Sterile Manufacturing area (1st floor)
April
22 23 24 25 26 27
No. Action
Coding of the return air and supply air outlets for the new Mon Tue Wed Thu Fri Sat

1
Checking
factory. of the online documents in both sterile and non

HOLIDAY
2
sterile area.of the facility from maintenance point of view.

3 Inspection
May
6 7 8 9 10 11
No. Action
Mon Tue Wed Thu Fri Sat

1 Revision of the HVAC validation protocol.

2 Inspection of the facility from maintenance point of view.
3 Studying BMS documents for the new factory.
May
13 14 15 16 17 18
No. Action
Mon Tue Wed Thu Fri Sat

Revision of the HVAC validation protocol.

Holiday
1

2 Studying BMS documents for the new factory.

 May
20 21 22 23 24 25
No. Action
Mon Tue Wed Thu Fri Sat

1 Revision of the HVAC validation protocol.

Studying BMS documents for the new factory.

Holiday
2

3 Studying validation documents of equipments for new factory

May Jun
27 28 29 30 31 1
No. Action
Mon Tue Wed Thu Fri Sat

1 Revision of the HVAC validation protocol.

2 Studying BMS documents for the new factory.
3 Studying validation documents of equipments for new factory
June
3 4 5 6 7 8
No. Action
Mon Tue Wed Thu Fri Sat

1 Revision of the HVAC validation protocol.

Studying BMS documents for the new factory.

Holiday
2

3 Studying validation documents of equipments for new factory

 June
10 11 12 13 14 15
No. Action
Mon Tue Wed Thu Fri Sat

1 Making validation protocols for GANSON machines

2 Making validation protocols for CEMACH machines
June
17 18 19 20 21 22
No. Action
Mon Tue Wed Thu Fri Sat

Making validation protocols for GANSON machines

Holiday
1

2 Making validation protocols for CEMACH machines

24 25 26 27 28 29
No. Action
Mon Tue Wed Thu Fri Sat

1 Making validation protocols for GANSON machines

2 Making validation protocols for CEMACH machines
24 25 26 27 28 29
No. Action
Mon Tue Wed Thu Fri Sat

1 Making validation protocols for GANSON machines

2 Making validation protocols for CEMACH machines
JULY
 1 2 3 4 5 6
No. Action
Mon Tue Wed Thu Fri Sat

Checking batch records

Holiday
1

2 Making validation protocols for CEMACH machines

JULY
8 9 10 11 12 13
No. Action
Mon Tue Wed Thu Fri Sat

1 Making validation protocols for CEMACH machines

2 Making validation protocols for other GANSON machines
15 16 17 18 19 20
No. Action
Mon Tue Wed Thu Fri Sat

1 Revision of safety features of finished protocols

2 Making validation protocols for other GANSON machines
22 23 24 25 26 27
No. Action
Mon Tue Wed Thu Fri Sat

1 Revision of safety features of finished protocols

Holiday
2 Making validation protocols for other GANSON machines
 July August
29 30 31 1 2 3
No. Action
Mon Tue Wed Thu Fri Sat

1 Revision of protocols according to format in VMP

Holiday
2 Making validation protocols for other GANSON machines
5 6 7 8 9 10
No. Action
Mon Tue Wed Thu Fri Sat

1 Making validation protocols for other GANSON machines

2 Revision of protocols according to format in VMP
12 13 14 15 16 17
No. Action
Mon Tue Wed Thu Fri Sat

1 Making validation protocols for other GANSON machines

Holiday

Holiday
2 Revision of protocols according to format in VMP

19 20 21 22 23 24
No. Action
Mon Tue Wed Thu Fri Sat
 Revision of protocols according to format as discussed in
1
Validation team meeting.

26 27 28 29 30 31
No. Action
Mon Tue Wed Thu Fri Sat

Revision of protocols according to format as discussed in

Holiday
1
Validation team meeting.

September
2 3 4 5 6 7
No. Action
Mon Tue Wed Thu Fri Sat

1 Inspection of manufacturing records

Revision of Validation Records according to the discussion in
2
Validation team meeting with K. Tamaskarn

9 10 11 12 13 14
No. Action
Mon Tue Wed Thu Fri Sat
Revision of Validation Protocols according to the discussion in

Holiday
1
Validation team meeting with K. Tamaskarn

16 17 18 19 20 21
No. Action
Mon Tue Wed Thu Fri Sat
 Revision of Validation Protocols according to the revised

Holiday
1
format.

23 24 25 26 27 28
No. Action
Mon Tue Wed Thu Fri Sat
Revision of Validation Protocols according to the revised
1
format.

Sept. October
30 1 2 3 4 5
No. Action
Mon Tue Wed Thu Fri Sat
Revision of Validation Protocols according to the revised
1
format.

7 8 9 10 11 12
No. Action
Mon Tue Wed Thu Fri Sat
Revision of Validation Protocols according to the revised

Holiday
1
format.

14 15 16 17 18 19
No. Action
Mon Tue Wed Thu Fri Sat
Revision of Validation Protocols according to the revised
1
format.

 21 22 23 24 25 26
No. Action
Mon Tue Wed Thu Fri Sat
Revision of Validation Protocols according to the revised

Holiday

Holiday
1
format.

October Nov.
28 29 30 31 1 2
No. Action
Mon Tue Wed Thu Fri Sat

1 Room and Equipment Coding for new facility

November
4 5 6 7 8 9
No. Action
Mon Tue Wed Thu Fri Sat

1 Room and Equipment Coding for new facility.

2 Perfomance Qualification of the Protocols
November
11 12 13 14 15 16
No. Action
Mon Tue Wed Thu Fri Sat

1 Room and Equipment Coding for new facility.

Holiday
 Holiday
2 Perfomance Qualification of the Protocols
November
25 26 27 28 29 30
No. Action
Mon Tue Wed Thu Fri Sat

1 Perfomance Qualification of the Protocols

December
2 3 4 5 6 7
No. Action
Mon Tue Wed Thu Fri Sat

Holiday

Holiday
1 Perfomance Qualification of the Protocols
December
9 10 11 12 13 14
No. Action
Mon Tue Wed Thu Fri Sat

1 Perfomance Qualification of the Protocols

16 17 18 19 20 21
No. Action
Mon Tue Wed Thu Fri Sat
1 Perfomance Qualification of the Protocols

23 24 25 26 27 28
No. Action
Mon Tue Wed Thu Fri Sat

1 Perfomance Qualification of the Protocols

 Details Remarks

50% complete

To be done next week

80% complete

To be done next week

To be done next week

Depends on the information

provided by K. Tamaskar

Details Remarks

70% complete

To be done next week

80% complete

50% complete

Depends on the information

provided by K. Tamaskar

Details Remarks

90% complete

50% complete

90%complete

90% complete

Depends on the information

provided by K. Tamaskar
 Details Remarks

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

Details Remarks

Not complete. Studying GAMP5

for computer system
validation.
To be done next week

Collecting information and

reference

Collecting information and

reference

Depends on the information

provided by K. Tamaskar

Details Remarks

Under progress

Under progress

Under progress
Depends on the information
provided by K. Tamaskar

Details Remarks

Under Progress

Under Progress

Depends on the information

provided by K. Tamaskar

Details Remarks
Depends on the information
provided by K. Tamaskar

Details Remarks

Depends on the information

provided by K. Tamaskar

Details Remarks
Depends on the information
provided by K. Tamaskar

Details Remarks

Depends on the information

provided by K. Tamaskar
 Details Remarks

Depends on the information

provided by K. Tamaskar

Details Remarks
Depends on the information
provided by K. Tamaskar

Details Remarks

Details Remarks
Details Remarks

Details Remarks

Details Remarks
PQ not complete yet

Have to revise again

Details Remarks

Details Remarks
Details Remarks

Details Remarks

Details Remarks
Details Remarks

Details Remarks

Details Remarks
 Details Remarks

Not complete yet

Details Remarks

Details Remarks

Not finish yet

Not finish yet

Details Remarks

Details Remarks

Details Remarks
Details Remarks

IQ Sifter SFT-500 completed

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

Details Remarks

Details Remarks
 Details Remarks

Details Remarks

Revision of safety features

pending

Details Remarks

Details Remarks

Revising the protocols according to

Protocols for other Ganson machine not the revised protocol content according
done yet to VMP. Still requires 3 more working
days
 Details Remarks

IQ of protocols completed, OQ still

remaining

Time consumed in checking the batch

IQ GAC 800 completed
records before final release

Details Remarks

GAC 800, HSMG 100L completed

OQ not completed yet

Details Remarks

HSMG 600L, U20

Details Remarks
 Details Remarks

Details Remarks

Details Remarks

Not completed as revised standard format

was not available

Details Remarks
Ganscoater GAC 800 IQ completed

Details Remarks

Ganscoater GAC800 OQ, Ganscomminutor

IQ/OQ completed

Details Remarks

IQ/OQ Ganson Multimill, IQ/OQ Gansons

VTS completed

Details Remarks

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

HSMG 600L completed

Details Remarks

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

U20 completed
 Details Remarks

Details Remarks

Details Remarks

Room coding done on the basis of

information available. Equipment
coding pending

Not done yet

Details Remarks
 Details Remarks

Not getting suitable reference

Details Remarks

Details Remarks

Not complete yet. Have to use other

reference.

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

Details Remarks
 JANUAR
13
No. Action
Mon

1 Review of Manufacturing records

2 Perfomance Qualification of the Protocols

JANUAR
20
No. Action
Mon

1 Perfomance Qualification of the Protocols

JANUARY/FE
27
No. Action
Perfomance Qualification of the HSMG
Mon

1
machine

2 Equipment and Room Coding for new factory

FEBRUA
3
No. Action
Mon

1 Revising attachments for VMP

2 Study about Freeze Drier

FEBRUA
17
No. Action
Mon

1 IQ/OQ FBD600
2 IQ/OQ V-Blender600

FEBRUARY/
24
No. Action
No. Action
Mon

1 Manufacturing records checking

2 IQ/OQ V-Blender600

3 Room Coding

March
3
No. Action
Mon

1 Room Coding
2 Equipment list and Coding

March
10
No. Action
Mon

1 Manufacturing records checking

2 Room Coding

March
17
No. Action
Mon

1 Manufacturing records checking

2 Revise PQ of equipments

March
24
No. Action
Mon

1 Manufacturing records checking

2 Revise PQ of equipments

March/ A
 31
No. Action
Mon

Manufacturing records checking

HOLIDAY
1

2 Revise PQ of equipments

April
7
No. Action
Mon

1 Revise PQ of equipments
May
5
No. Action
Mon
Revise PQ of equipments as revised by K.
1
Tamaskar

May
12
No. Action
Mon

1 Review manufacturing records

Revise PQ of equipments as revised by K.
2
Tamaskar

May
19
No. Action
Mon

1 Revise PQ of GAC 800

Summarize and prepare attachments for
2
QVMP

May
26
No. Action
Mon
Summarize and prepare attachments for
1
QVMP

 June
9
No. Action
Mon
Summarize and prepare attachments for
1
QVMP

June
16
No. Action
Summarize and prepare attachments for Mon

1
QVMP

2 Prepare pending PQ protocols

June
23
No. Action
Mon

1 Check manufacturing records

Summarize and prepare attachments for
2
QVMP
3 Prepare pending PQ protocols

June/Ju
30
No. Action
Mon

1 Prepare pending PQ protocols

Augus
18
No. Action
Mon

1 Prepare URS for all the protocols

Sept
8
No. Action
Mon
1 Check Manufacturing documents
2 Prepare URS for all the protocols

Sept
15
No. Action
Mon

1 Check Manufacturing documents

2 Prepare URS for all the protocols

Sept
22
No. Action
Mon

1 Prepare URS for all the protocols

Sept/O
29
No. Action
Mon

1 Prepare URS for all the protocols

Oct
6
No. Action
Mon
QA inpection for the preparation of GMP
1
audit in November

2 Revise URS for all the protocols
Oct
13
No. Action
Mon
QA inpection for the preparation of GMP
1
audit in November

2 Revise URS for all the protocols
Oct
20
No. Action
Mon
QA inpection for the preparation of GMP
1
audit in November

Holiday
2 Risk Assessment for Manfucaturing processes

Oct/No
27
No. Action
Mon
QA inpection for the preparation of GMP
1
audit in November
2 Checking Manufacturing documents
3 Risk Assessment for Manufacturing processes
Nov
3
No. Action
Mon
QA inpection for the preparation of GMP
1
audit in November
2 Risk Assessment for Manufacturing processes
Nov
10
No. Action
Mon
QA inpection for the preparation of GMP
1
audit in November
2 Risk Assessment for Manufacturing processes
 Nov
24
No. Action
Mon
QA inpection for the preparation of GMP
1
audit in November
2 Checking Manufacturing records
3 Risk Assessment for Manufacturing processes

Decemb
1
No. Action
Mon

1 Checking Manufacturing records

3 Risk Assessment for Manufacturing processes

3 Follow up for the preparation of GMP audit

 JANUARY
14 15 16 17 18
Details Remarks
Tue Wed Thu Fri Sat

Holiday

JANUARY
21 22 23 24 25
Details Remarks
Tue Wed Thu Fri Sat

Only HSMG M/C remaining

JANUARY/FEBRUARY
28 29 30 31 1
Details Remarks
Tue Wed Thu Fri Sat

FEBRUARY
4 5 6 7 8
Details Remarks
Tue Wed Thu Fri Sat

HOLIDAY

FEBRUARY
18 19 20 21 22
Details Remarks
Tue Wed Thu Fri Sat

FEBRUARY/MARCH
25 26 27 28 1
Details Remarks
 Details Remarks
Tue Wed Thu Fri Sat

HOLIDAY


March
4 5 6 7 8
Details Remarks
Tue Wed Thu Fri Sat

March
11 12 13 14 15
Details Remarks
Tue Wed Thu Fri Sat

HOLIDAY

March
18 19 20 21 22
Details Remarks
Tue Wed Thu Fri Sat

March
25 26 27 28 29
Details Remarks
Tue Wed Thu Fri Sat

HOLIDAY

March/ April
1 2 3 4 5
Details Remarks
Tue Wed Thu Fri Sat

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

April
8 9 10 11 12
Details Remarks
Tue Wed Thu Fri Sat
Holiday

May
6 7 8 9 10
Details Remarks
Tue Wed Thu Fri Sat
Holiday

May
13 14 15 16 17
Details Remarks
Tue Wed Thu Fri Sat

Holiday

Ganscoater 800 remaining

May
20 21 22 23 24
Details Remarks
Tue Wed Thu Fri Sat

Holiday

May
27 28 29 30 31
Details Remarks
Tue Wed Thu Fri Sat
Holiday

 June
10 11 12 13 14
Details Remarks
Tue Wed Thu Fri Sat

Holiday

June
17 18 19 20 21
Details Remarks
Tue Wed Thu Fri Sat

Holiday

Not completed as had to

check Manufacturing records

June
24 25 26 27 28
Details Remarks
Tue Wed Thu Fri Sat
Holiday

June/July
1 2 3 4 5
Details Remarks
Tue Wed Thu Fri Sat
Holiday

August
19 20 21 22 23
Details Remarks
Tue Wed Thu Fri Sat
Holiday

Sept
9 10 11 12 13
Details Remarks
Tue Wed Thu Fri Sat


Holiday

Sept
16 17 18 19 20
Details Remarks
Tue Wed Thu Fri Sat

Holiday

VTS, Comil U20, Multimill,

Ganscomminutor done

Sept
23 24 25 26 27
Details Remarks
Tue Wed Thu Fri Sat
Holiday

Sept/Oct
30 1 2 3 4
Details Remarks
Tue Wed Thu Fri Sat
Holiday

Revsion Pending

Oct
7 8 9 10 11
Details Remarks
Tue Wed Thu Fri Sat

Holiday

Oct
14 15 16 17 18
Details Remarks
Tue Wed Thu Fri Sat

Holiday
 Holiday

Oct
21 22 23 24 25
Details Remarks
Tue Wed Thu Fri Sat

Holiday

Holiday

Oct/Nov
28 29 30 31 1
Details Remarks
Tue Wed Thu Fri Sat

Holiday

Nov
4 5 6 7 8
Details Remarks
Tue Wed Thu Fri Sat

Holiday

Nov
11 12 13 14 15
Details Remarks
Tue Wed Thu Fri Sat

Holiday

 Nov
25 26 27 28 29
Details Remarks
Tue Wed Thu Fri Sat

Holiday

December
2 3 4 5 6
Details Remarks
Tue Wed Thu Fri Sat
Holiday

ill cover most of the equipments.
 Jan
5 6
No. Action
Mon Tue
Verifying Certificates and Documents of
1
Neela Water System

Jan
12 13
No. Action
Mon Tue
Verify Certificates and Documents of
1
Neela Water System

2 Verify GA drawing of the equipments

Jan
19 20
No. Action
Mon Tue

1 Verify GA drawing of the equipments

2 Verify drains of each room

Prepare Room label with both new and
3
old coding

Jan
26 27
No. Action
Mon Tue

1 Verify GA drawing of the equipments

User Point Verification of Sterile Side for
2
PW, WFI and PSG
3 Verify the rooms from METECNO drawing.
F
2 3
No. Action
No. Action
Mon Tue

1 Verify GA drawing of the equipments

User Point Verification of Sterile Side for
2
PW, WFI and PSG

F
9 10
No. Action
Mon Tue

1 Verify GA drawing of the equipments

Ma
2 3
No. Action
Mon Tue

Compile Utility requirement for all the

1
equipments

2 Verify GA drawing of the equipments

Ma
9 10
No. Action
Mon Tue

Verify GA drawing of the equipments

Dismantle all the rejected valves(Neela
1

2 Water System) and supervise there proper

packing.

Ma
16 17
No. Action
Mon Tue

1 Verify GA drawing of the equipments

Verify the opening for the Supply air and
2
Return as per drawing.
 Ma
16 17
No. Action
Mon Tue

1 Verify GA drawing of the equipments

Verify the opening for the Supply air and
2
Return as per drawing.

Ma
24 25
No. Action
Mon Tue

1 Verify GA drawing of the equipments

Verify the opening for the Supply air and
2
Return as per drawing.

Marc
30 31
No. Action
Mon Tue
Verify the opening for the Supply air and
1
Return as per drawing.

A
6 7
No. Action
Mon Tue
Verify the switches and conduits against
1
the drawing

A
20 21
No. Action
Mon Tue
Verify the switches and conduits against
1
the drawing

 M
4 5
No. Action
Mon Tue

Measure the position of the drains in each room and

1
put it on drawing.
Verify the switches and conduits against
2
the drawing

M
11 12
No. Action
Mon Tue

Measure the position of the drains in each room and

1
put it on drawing.
Verify the switches, conduits and lighting
2
marks against the drawing

M
18 19
No. Action
Mon Tue
Measure the position of the drains in
1
each room and put it on drawing.

Verify all the received machines against
2 the packing list and assign room number
to them for shifting

M
25 26
No.
Verify compressed Action
air points for process Mon Tue

1 areas against the plan provided by Khun

Tamaskar.
 Follow up and verify the modified marking
2
for accomodating the lighting panels.

Ju
1 2
No. Action
Mon Tue
Remove rejected NEELA valves and
1
there packing

Ju
8 9
No. Action
Mon Tue
Remove rejected NEELA valves and
1
there packing

Ju
15 16
No. Action
Mon Tue

Check and Verify the Machine Transfer in

1
the processing areas

Remove rejected NEELA valves and
2
there packing

June
29 30
No. Action
Doing impact assessment for the
Mon Tue

1
machines

Ju
6 7
No. Action
Mon Tue
 Doing impact assessment for the
1
machines

Ju
13 14
No. Action
Mon Tue

1 Working with K Tamaskar

Doing impact assessment for the
2
machines

Ju
20 21
No. Action
Doing impact assessment for the
Mon Tue

1
machines

July/A
27 28
No. Action
Doing impact assessment for the
Mon Tue

1
machines

Au
3 4
No. Action
Mon Tue

Incorporating risk assessment in the

1
Validation Protocol where ever possible

Revising room numbering of the plant on
2
the basis of as built status.
 Au
10 11
No. Action
Mon Tue

1 Working with Khun Tamaskar

Au
17 18
No. Action
Mon Tue

Revising room numbering of the plant on

1
the basis of as built status.
Make separate autocad drawing for
2
normal and steam condensate drain.

Make line diagram for PW, WFI and PSG
3
and add new User Points.

Au
24 25
No. Action
Mon Tue

Incorporating risk assessment in the

1
Validation Protocol where ever possible

August/ S
31 1
No. Action
Mon Tue

Incorporating risk assessment in the

1
Validation Protocol where ever possible

Holiday

Working with Mr. Tamaskar and taking

2
follow up of the remaining jobs
 Sept
7 8
No. Action
Marking position for the installation of
Mon Tue

1
Passbox

Incorporating risk assessment in the
2
Validation Protocol where ever possible

Working with Mr. Tamaskar and taking

3
follow up of the remaining jobs

Sept
14 15
No. Action
Mon Tue

Follow up of the work in progress in

1
plant.

Incorporating risk assessment in the
2
Validation Protocol where ever possible

Sept
22 23
No. Action
Verification of the installation of Return
Mon Tue

1 double wall, switch, plug, smoke detector

and light fittings in Non Sterile area

Septembe
28 29
No. Action
Mon Tue

1 Working with K. Tamaskar and follow up

2 Installation of Passbox

3 Verification of the removable panel

Oct
5 6
No. Action
Mon Tue

Discuss QC utility Requirements with Khu

1
Punnada

2 Shift Autoclaves according to final drawing
Verify position of the new process drains
3
with technicians
Discuss drawing for installation of new
4
process drains with Khun Thep

Oct
12 13
No. Action
Make LBS utility requirement as per room
Mon Tue

1
detail

2 Shift Autoclaves according to final drawing
Verify position of the new process drains
3
with technicians
Follow up of the installation of return
4 panel for HVAC and installation of
Passbox

Oct
19 20
No. Action
No. Action
Follow up of the work by Metechno
Mon Tue

1
contractor

2 Shift Autoclaves according to final drawing

Oct
26 27
No. Action
Follow up of the work by Metechno
Mon Tue

1
contractor

Nove
2 3
No. Action
Mon Tue

Follow up of the work by Metechno

1
contractor and working with Mr. Tamaskar.

Nove
9 10
No. Action
Follow up of the work by Metechno
Mon Tue

1
contractor.

2 Passbox Installation

Nove
16 17
No. Action
Follow up of the work by Metechno
Mon Tue

1
contractor.

2 IQ Protocol document verification

Novembe
 30 1
No. Action
Make the inventory of the equipments Mon Tue

1 and spare parts received against the

packing list.

Dece
7 8
No. Action
Mon Tue

1 Installation of LAF in RM sampling room

Make the inventory of the equipments
2 and spare parts received against the
packing list.

Dece
14 15
No. Action
Make the inventory of the equipments Mon Tue

1 and spare parts received against the

packing list.

Dece
21 22
No. Action
Make the inventory of the equipments Mon Tue

1 and spare parts received against the

packing list.

Decembe
28 29
No. Action
Make the inventory of the equipments Mon Tue

1 and spare parts received against the

packing list.

Jan
 4 29
No. Action
Make the inventory of the equipments Mon Tue

1 and spare parts received against the

packing list.
 January
7 8 9 10
Details
Wed Thu Fri Sat

Holiday

January
14 15 16 17
Details
Wed Thu Fri Sat

Holiday

January
21 22 23 24
Details
Wed Thu Fri Sat

January
28 29 30 31
Details
Wed Thu Fri Sat

Feb
4 5 6 7
Details
 Details
Wed Thu Fri Sat

Some points not clear from drawing

Feb
11 12 13 14
Details
Wed Thu Fri Sat

Holiday

March
4 5 6 7
Details
Wed Thu Fri Sat
Holiday

Holiday

March
11 12 13 14
Details
Wed Thu Fri Sat

Cannot continue as Metecno person

were cutting panels in the room

Made the list already but cannot

dimantle. Waiting for confirmation
from Khun Lheela

March
18 19 20 21
Details
Wed Thu Fri Sat

Holiday

 March
18 19 20 21
Details
Wed Thu Fri Sat

FBD and Ganscoater complete

Holiday

March
26 27 28 29
Details
Wed Thu Fri Sat

Non Sterile side complete, Sterile side

waiting for revised drawing from
Airflow for return and supply.

March/ April
1 2 3 4
Details
Wed Thu Fri Sat
Holiday

April
8 9 10 11
Details
Wed Thu Fri Sat

Flooring work under progress so

unable to assess all the corridors

April
22 23 24 25
Details
Wed Thu Fri Sat

 May
6 7 8 9
Details
Wed Thu Fri Sat

Work not complete as

Holiday
flooring work under
progress

May
13 14 15 16
Details
Wed Thu Fri Sat

Incomplete as flooring
work in sterile area under
progress

May
20 21 22 23
Details
Wed Thu Fri Sat

Changed Saturday
Holiday

May
27 28 29 30
Details
Wed Thu Fri Sat

Holiday
 Holiday

June
3 4 5 6
Details
Wed Thu Fri Sat

Holiday
Packing material not
sufficient.

June
10 11 12 13
Details
Wed Thu Fri Sat

June
17 18 19 20
Details
Wed Thu Fri Sat

Holiday

Non Sterile Side complete,

Sterile Side some rooms
remaining.

June/ July
1 2 3 4
Details
Wed Thu Fri Sat
Holida

Collecting Information
y

July
8 9 10 11
Details
Wed Thu Fri Sat
 Holida

y
July
15 16 17 18
Details
Wed Thu Fri Sat

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

July
22 23 24 25
Details
Wed Thu Fri Sat

Not finished yet

July/August
29 30 31 1
Details
Wed Thu Fri Sat
Holida

Holida

August
5 6 7 8
Details
Wed Thu Fri Sat

Holiday

 August
12 13 14 15
Details
Wed Thu Fri Sat
Holida

August
19 20 21 22
Details
Wed Thu Fri Sat

Holiday

August
26 27 28 29
Details
Wed Thu Fri Sat

Working on Freeze
Holiday

Drier

August/ September
2 3 4 5
Details
Wed Thu Fri Sat
31 Aug- Went to
immigration for
making yearly VISA

 September
9 10 11 12
Details
Wed Thu Fri Sat

Risk Assessment
not done as was

busy in transferring

Holiday
equipments in
rooms.

September
16 17 18 19
Details
Wed Thu Fri Sat

September
24 25 26 27
Details
Wed Thu Fri Sat
Holiday

September/ October
30 1 2 3
Details
Wed Thu Fri Sat

 Marking on the panels
done to accommodate
Passbox

October
7 8 9 10
Details
Wed Thu Fri Sat

Technicians not free

Holiday

Waiting for Khun Thep to

assign job to Technician

October
14 15 16 17
Details
Wed Thu Fri Sat

Technician not available

Waiting for Khun Thep to

assign job to technician

October
21 22 23 24
Details
 Details
Wed Thu Fri Sat

October
28 29 30 31
Details
Wed Thu Fri Sat

Holida

y

November
4 5 6 7
Details
Wed Thu Fri Sat

November
11 12 13 14
Details
Wed Thu Fri Sat

Holiday

November
18 19 20 21
Details
Wed Thu Fri Sat

Holiday

November/December
 2 3 4 5
Details
Wed Thu Fri Sat

Holiday

December
9 10 11 12
Details
Wed Thu Fri Sat

December
16 17 18 19
Details
Wed Thu Fri Sat

December
23 24 25 26
Details
Wed Thu Fri Sat

Non Sterile Finished

December/ January
30 31 1 2
Details
Wed Thu Fri Sat

HOLIDAY

January
30 31 1 2
Details
Wed Thu Fri Sat

HOLIDAY
Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks
 Remarks

Remarks
Wed- Go to Immigration
for transferring Visa in
new passport

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks
Remarks
 WEEKLY ACTION PLAN - JAI - M/C INS

J
No. Action 11
Mon

1
Installation of Equipments with Ganson
Engineer
J
No. Action 18
Mon

1
Installation of Laminar flow in Dispensing
and Sampling areas
J
No. Action 25
Mon

1
Installation of Laminar flow in Dispensing
and Sampling areas

No. Action 1
Mon

1
Working with Mr. Tamaskar
No. Action 8
Mon

1
Working with Mr. Tamaskar

No. Action 15
Mon

1
Follow up installation of Laminar Flow
2
Making Tap water requirement points in
production area. Fe
No. Action 29
Mon

1
Making Protocols for FBP100L
2
Working with Mr. Tamaskar

No. Action 14
Mon

1
Checking of sealing by Metechno on
partition panels
Ma
No. Action 28
Mon

1
Follow up of installation of Plant steam and
compress air.
2
Working with Mr. Tamaskar and checking of
sealing by Metechno on partition panels

No. Action 4
Mon

1
Marking of drain location in Sterile Area
2
IQ of Freeze Drier (Component Check)

No. Action 11
Mon

1
IQ Autoclave Room no. 166,156
No. Action 18
Mon

1
IQ Autoclave Room no. 156,154,137,132

No. Action 25
Mon

1
Klenzaids washer and sterilizing tunnel
2
IQ WFI and PSG

No. Action 2
Mon

Holiday
1
Klenzaids washer and sterilizing tunnel
2
Ampoule filling machine

No. Action 9
Mon

1
Installation of WFI & Autoclave with
Pharmalab Engineer

No. Action 16
Mon

1
IQ Klenzaids washer and sterilizing tunnel
No. Action 23
Mon

1
Follow up QC partitioning
2
Klenzaids Ampoule filling machine

M
No. Action 30
Mon

1
Working with Khun Tamaskar
No. Action 13
Mon

1
IQ component check FBD 180 Kg line
2
IQ component check FBD 30 Kg line

No. Action 20
Mon

1
IQ component Dry Granulation line
2
IQ component check Ganscoater GAC 800

J
No. Action 27
Mon

1
Working with Khun Tamaskar
No. Action 4
Mon

1
IQ component check Ganscoater GAC 800
2
Verification of Socket in QC

No. Action 25
Mon

1
Working with Khun Tamaskar
No. Action 1
Mon

1
IQ component check Ganscoater GAC 1200
2
New Drain installation verification
No. Action 8
Mon

1
IQ component check VEGA TX30

No. Action 22
Mon

1
Follow up of Plug and Switch installation in
QC
A
No. Action 29
Mon

1
IQ of AHUs
2
Working with Mr. Tamaskar

Se
No. Action 12
Mon
1
Revise IQ of all AHUs according to new
supplier documents.

Se
No. Action 19
Mon

1
IQ of AHU-01
2
IQ of AHU-02

Septem
No. Action 26
Mon

1
IQ of AHU-03
2
IQ of AHU-04

O
No. Action 3
Mon

1
IQ of AHU-05
2
IQ of AHU-06

O
No. Action 10
Mon

1
IQ of AHU-07
2
IQ of AHU-08
 O
No. Action 17
Mon

1
IQ of AHU-09
2
IQ of AHU-10

O
No. Action 24
Mon

1
IQ of AHU-11
2
IQ of AHU-12

3
Working with Khun Tamaskar
Octobe
No. Action 31
Mon

1
IQ of AHU-13
2
IQ of AHU-14

N
No. Action 7
Mon

1
IQ of AHU-15
2
IQ of AHU-16

N
No. Action 14
No. Action
Mon

1
IQ of AHU-17
2
IQ of AHU-18

N
No. Action 21
Mon

1
IQ of AHU-42
2
IQ of AHU-54

Novem
No. Action 28
Mon

1
IQ of AHU-19
2
IQ of AHU-20

D
No. Action 19
Mon

1
IQ of AHU-21
2
Holiday
IQ of AHU-23-1

D
No. Action 26
Mon

1
Working with Khun Tamaskar
1
IQ of AHU-23-2
2
IQ of AHU - 25
ION PLAN - JAI - M/C INSTALLATION, IQ,
Planned In process Done

January
12 13 14 15 16 Details
Tue Wed Thu Fri Sat

Holiday

January
19 20 21 22 23 Details
Tue Wed Thu Fri Sat

Holiday

January
26 27 28 29 30 Details
Tue Wed Thu Fri Sat

Feb
2 3 4 5 6 Details
Tue Wed Thu Fri Sat

Holiday

Feb
9 10 11 12 13 Details
Tue Wed Thu Fri Sat
Checking change in layout as

compared to FDA approved

drawing and other miscellaneous
work.

Feb
16 17 18 19 20 Details
Tue Wed Thu Fri Sat

Holiday

 Holiday

Feb/March
1 2 3 4 5 Details
Tue Wed Thu Fri Sat

Holiday

March
15 16 17 18 19 Details
Tue Wed Thu Fri Sat

March/April
29 30 31 1 2 Details
Tue Wed Thu Fri Sat
Holiday

April
5 6 7 8 9 Details
Tue Wed Thu Fri Sat

Some components not

checked as there are no
Tags on the machine to
identify the same

April
12 13 14 15 16 Details
Tue Wed Thu Fri Sat

HOLIDAY
 April
19 20 21 22 23 Details
Tue Wed Thu Fri Sat

Holiday

April
26 27 28 29 30 Details
Tue Wed Thu Fri Sat

May
3 4 5 6 7 Details
Tue Wed Thu Fri Sat
Holiday

Not Complete

Not Complete

May
10 11 12 13 14 Details
Tue Wed Thu Fri Sat

May
17 18 19 20 21 Details
Tue Wed Thu Fri Sat

Continue
Holiday

May
24 25 26 27 28 Details
Tue Wed Thu Fri Sat

May/ June
31 1 2 3 4 Details
Tue Wed Thu Fri Sat
HOLIDAY

June
14 15 16 17 18 Details
Tue Wed Thu Fri Sat
HOLIDAY

June
21 22 23 24 25 Details
Tue Wed Thu Fri Sat

June/ July
28 29 30 1 2 Details
Tue Wed Thu Fri Sat
HOLIDAY

July
5 6 7 8 9 Details
Tue Wed Thu Fri Sat
HOLIDAY

 HOLIDAY

July
26 27 28 29 30 Details
Tue Wed Thu Fri Sat

Aug
2 3 4 5 6 Details
Tue Wed Thu Fri Sat

HOLIDAY

Aug
9 10 11 12 13 Details
Tue Wed Thu Fri Sat
HOLIDAY

HOLIDAY

HOLIDAY

Waiting for technical documents

from supplier

Aug
23 24 25 26 27 Details
Tue Wed Thu Fri Sat

Aug/ Sept
30 31 1 2 3 Details
Tue Wed Thu Fri Sat
HOLIDAY

AHU-01 under progress

September
13 14 15 16 17 Details
Tue Wed Thu Fri Sat
 HOLIDAY

September
20 21 22 23 24 Details
Tue Wed Thu Fri Sat

Some parameters not

checked, will be checked at
the time of commissioning

September/October
27 28 29 30 1 Details
Tue Wed Thu Fri Sat

Some parameters not

checked, will be checked at
HOLIDAY

the time of commissioning

October
4 5 6 7 8 Details
Tue Wed Thu Fri Sat

October
11 12 13 14 15 Details
Tue Wed Thu Fri Sat

HOLIDAY

 October
18 19 20 21 22 Details
Tue Wed Thu Fri Sat

October
25 26 27 28 29 Details
Tue Wed Thu Fri Sat

October/ November
1 2 3 4 5 Details
Tue Wed Thu Fri Sat

HOLIDAY

November
8 9 10 11 12 Details
Tue Wed Thu Fri Sat

HOLIDAY

November
15 16 17 18 19 Details
 Details
Tue Wed Thu Fri Sat

November
22 23 24 25 26 Details
Tue Wed Thu Fri Sat

HOLIDAY

November/ December
29 30 1 2 3 Details
Tue Wed Thu Fri Sat

HOLIDAY

December
20 21 22 23 24 Details
Tue Wed Thu Fri Sat

Holiday


December
27 28 29 30 31 Details
Tue Wed Thu Fri Sat
HOLIDAY

Unable to complete as was
working with Khun
Tamaskar regarding FDA
comments.
 HOLIDAY
Unable to complete as was
working with Khun
Tamaskar regarding FDA
comments.

Remarks

Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks
Remarks

Remarks

Remarks

Remarks

Remarks
 WEEKLY ACTION PLAN - JAI - M/C INSTALLATION, IQ
Planned In process

January
No. Action 2 3 4 5
Mon Tue Wed Thu

Holiday
1
IQ of
AHU-23-2

January
No. Action 9 10 11 12
Mon Tue Wed Thu

1
IQ of
2
IQ of
AHU-24
AHU-25 January
No. Action 16 17 18 19
Mon Tue Wed Thu

1
IQ of
2
IQ of
AHU-26
AHU-27 January
No. Action 23 24 25 26
Mon Tue Wed Thu

1
IQ of
2
IQ of
AHU-33
AHU-34
January
No. Action 30 31 1 2
Mon Tue Wed Thu

1
IQ of
2
IQ of
AHU-35
AHU-36
/C INSTALLATION, IQ,
Done

6 7 Details Remarks
Fri Sat
Holiday

13 14 Details Remarks
Fri Sat

20 21 Details Remarks
Fri Sat
Holiday

27 28 Details Remarks
Fri Sat

3 4 Details Remarks
Fri Sat
Holiday