Weekly action plan QA Inspector

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

1 VMP

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

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

HOLIDAY
2 HVAC

Modify the protocols on the basis of information provided by K. Tamaskar. 80% complete

Make separate protocol for AHUs. To be done next week

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

If information available, make protocol for the major components of the HVAC system. Depends on the information
provided by K. Tamaskar

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

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

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

 2 HVAC

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

Make separate protocol for AHUs. 80% complete

Make general validation protocol for HVAC system. 50% complete

If information available, make protocol for the major components of the HVAC system. Depends on the information
provided by K. Tamaskar

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

Revise VMP on the basis of PIC/S and ISPE guideline 90% complete

Planning and Schedule table (indicative only) 50% complete

HOLIDAY
2 HVAC

Make separate protocol for AHUs. 90%complete

Make general validation protocol for HVAC system. 90% complete

If information available, make protocol for the major components of the HVAC system. Depends on the information
provided by K. Tamaskar

SEPTEMBER
24 25 26 27 28 29
No. Action Details
No. Action Details
Mon Tue Wed Thu Fri Sat
1 VMP
Computer system validation, SAT

Revise VMP on the basis of PIC/S and ISPE guideline and information regarding utilities
not done.

Equipment list completed for the

new factory on the basis of

information provided by K.
Tamaskar
Planning and Schedule table (indicative only)
2 HVAC

Make separate protocol for AHUs. IQ protocol for AHU done but OQ
pending

Make general validation protocol for HVAC system. Done on the basis of information
available. Information for major
components not available.

If information available, make protocol for the major components of the HVAC system. Depends on the information
provided by K. Tamaskar

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

Not complete. Studying GAMP5

Complete the VMP for the pending topics for computer system validation.

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

HOLIDAY
2 HVAC

Make OQ for AHUs Collecting information and

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

If information available, make protocol for the major components of the HVAC system. Depends on the information
provided by K. Tamaskar

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

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

Planning and Schedule table (indicative only)

2 HVAC

Make OQ for AHUs Under progress

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

If information available, make protocol for the major components of the HVAC system. Depends on the information
provided by K. Tamaskar

October
15 16 17 18 19 20
No. Action Details
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 Under Progress

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

If information available, make protocol for the major components of the HVAC system. Depends on the information
provided by K. Tamaskar

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

Revise VMP as per K.Wara comments and make attachment list for VMP
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 system. Depends on the information
provided by K. Tamaskar

October/November
 29 30 31 1 2 3
No. Action Details
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. Depends on the information
provided by K. Tamaskar

November
5 6 7 8 9 10
No. Action Details
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. Depends on the information
provided by K. Tamaskar
 November
12 13 14 15 16 17
No. Action Details
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 system. Depends on the information
provided by K. Tamaskar

November
19 20 21 22 23 24
No. Action Details
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. Depends on the information
provided by K. Tamaskar

December
10 11 12 13 14 15
No. Action Details
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. Depends on the information
provided by K. Tamaskar

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

Master Validation Plan for HVAC

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

SOP for Enviromental Monitoring

 Year 2013

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

Master Validation Plan for HVAC

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

Master Validation Plan for HVAC

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

Master Validation Plan for HVAC

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
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