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Process Validation Protocol

The document outlines 10 validation and qualification activities conducted in January 2020, including reports for tunnel sterilizers, autoclaves, an ampoule washing machine, HVAC validation, and requalification of various ovens and AHUs. Each activity lists the initiation and completion dates, responsible owner, and associated Veeva numbers for protocols and reports. Colour coding is used to indicate the weeks that activities were initiated or completed.

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prakash
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86 views27 pages

Process Validation Protocol

The document outlines 10 validation and qualification activities conducted in January 2020, including reports for tunnel sterilizers, autoclaves, an ampoule washing machine, HVAC validation, and requalification of various ovens and AHUs. Each activity lists the initiation and completion dates, responsible owner, and associated Veeva numbers for protocols and reports. Colour coding is used to indicate the weeks that activities were initiated or completed.

Uploaded by

prakash
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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Sr.

No Details of the Activity Initiated Completed


Jan-20
1 Media fill Dec.2019 Dec.2019
Owner Veeva No.

Rohan VV-QUAL-620909

Colour coding
1st week
2nd week
3rd week
4th week
Sr. No Details of the Activity Initiated Completed
Jan-20
1 Report of Tunnel sterlizer 1,2 & 3 1/13/2019 1/13/2019
2 Bowie-dick of doubble door autoclave 1/17/2019 1/17/2019
Bowie-diec of Injectable autoclave autoclave
3 ATL-4,5 & 6 1/15/2019 1/15/2019
4 Injectable Autoclave-4 1/17/2020 1/17/2020
5 Injectable Autoclave-5 1/16/2020 1/16/2020
6 Injectable Autoclave-6 1/15/2020 1/15/2020
7 Injectable Autoclave-7 1/17/2020 1/17/2020
9 Ampoule washing machine 1/21/2020 1/22/2020
8 EISAI 1 mahine report 1/25/2020 1/25/2020

Feb-20
10 HVAC validation in injectable 12/1/2019 2/4/2020
Owner Veeva No.(Report)

Pralhad VV-QUAL-654074
Pralhad VV-QUAL-654084

Pralhad VV-QUAL-655484
Pralhad VV-QUAL-657433
Pralhad VV-QUAL-657435
Pralhad VV-QUAL-657436
Pralhad VV-QUAL-657450
Pralhad VV-QUAL-660857
Pralhad VV-QUAL-659879

Pralhad VV-QUAL-659234 Colour coding


1st week
2nd week
3rd week
4th week
Sr. No Details of the Activity Initiated Completed Owner
Jan-20
Veeva No.(Protocol) Veeva No.(Report)

Colour coding
1st week
2nd week
3rd week
4th week
Sr. No Details of the Activity Initiated Completed
Jan-20
1 Cleaning Validation of Met-Neurobion
Owner Veeva No.(Protocol) Veeva No.(Report)

Rohan Palei VV-QUAL-659209

Colour coding
1st week
2nd week
3rd week
4th week
Colour coding
Sr. No Details of the Activity Initiated Completed Owner
Jan-20
performance qualification report of control panel of
1 purified water generation system 12/10/2019 1/10/2020 Pralhad
REQUALIFICATION OF DEPYROGENATION OVEN EQ.
2 ID-IN01-QC-OV6 1/31/2020 ROHAN
REQUALIFICATION OF DRYING OVEN EQ. ID-IN01-QC-
3 HD03 1/31/2020 ROHAN
REQUALIFICATION OF DRYING OVEN EQ. ID-IN01-QC-
4 OV5 1/31/2020 ROHAN
REQUALIFICATION OF VACUUM OVEN EQ. ID-IN01-
5 QC-VO2 1/31/2020 ROHAN
REQUALIFICATION OF VACUUM OVEN EQ. ID-IN01-
6 QC-VO3 1/31/2020 ROHAN
REQUALIFICATION OF VACUUM OVEN EQ. ID-IN01-
7 QC-VO4 1/31/2020 ROHAN
8 REQUALIFICATION OF QC AHU1 ROHAN
9 REQUALIFICATION OF QC AHU2 ROHAN
10 REQUALIFICATION OF QC AHU3 ROHAN
Veeva No.(Protocol) Veeva No.(Report)

VV-QUAL-612580 VV-QUAL-622329

VV-QUAL-622319

VV-QUAL-622320

VV-QUAL-622321

VV-QUAL-622322

VV-QUAL-622323

VV-QUAL-622324
VV-QUAL-655670
VV-QUAL-655671
VV-QUAL-655672 Colour coding
1st week
2nd week
3rd week
4th week
Colour coding
Sr. No Details of the Activity Veeva No.(Protocol)
Jan-20
PREPARATION, APPROVAL AND ISSUANCE OF MANUALS
1 VV-QUAL-621956
AND SITE MASTER FILE , AT MERCK GOA SITE

2 Protocol for HMI and PLC Validation of pretreatment VV-QUAL-623274


plant
Protocol for removal of heat exchanger in pre treatment
3 plant of Injectable department VV-QUAL-654592

PROTOCOL FOR PERFORMANCE QUALIFICATION OF


SHIMADZU UV-VISIBLE SPECTROPHOTOMETER WITH Eq.
4 ID No.IN01/QC/UVS4 VV-QUAL-655848
5 Transport validation study for Non Reefer Vehicle VV-QUAL-657958
PROTOCOL FOR COMPARATIVE STUDY OF
EFFECTIVENESS OF DECONTAMINATION PROCESS
AT 121 DEG. FOR 45 MIN. AND 121DEG. FOR 60
6 MIN. VV-QUAL-652230
PROTOCOL FOR EVALUATION OF
PRETREATMENT PLANT OF INJECTABLE
7 WATER SYSTEM VV-QUAL-600509
Owner Effective date Veeva No.(Report) Effective date
Jan-20

Prakash Gawas

Prakash Gawas
Colour coding
Prakash Gawas
1st week

Prakash Gawas
2nd week
Rohan Palei 3rd week

Prakash Gawas
VV-QUAL-660067 4th week

Prakash Gawas
5th week
Colour coding

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