Document name: Campaign Length Report For …… on machines ,

…….

Document Code: CVP-000.00

Issue Date: xx/x/xxx Pages No.: Page 1 of 12

CAMPAIGN LENGTH
REPORT FOR PRODUCT ……
ON MACHINE S ……
 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 2 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

Approval Page:

Concenred Persons signing below verify that the execution of this report, related results & accept
his summery & conclusion.

Title Name Signature Date

Report
QA Supervisor
Prepared by:

Production Manager
Reviewed by:

QC Manager

Approved by: QA Manager

 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 3 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

1 CAMPAIGN LENGTH GENERAL INFORMATION

Run Number : .1.

Product Name

Batch Size

Last Cleaning Date

Used Machine Diosna Capsule filling Blisering

Batch No
First bacth in campaign
Date of start / Time

Batch No

Last Batch in campaign Date of start

Date of End/ Time

NB of continuous manufacturing days

NB of manufactured batches

Production Representative

QA Representative
 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 4 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

Batches under Validation

Date of start of manufacuring process on following machine

Batch # Machine

Diosna Powder Fill Machine

Environmental Monitoring
ROOM Tempreture Humidity Diffrential pressure
Limit (----- - --------) Limit (----- - --------) Limit (----- - --------)
 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 5 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

2 PRODUCT TESTING

Testing Parameters
Run # /
Step Sample No Micro
B. NO Appearance Assay related
enum..

Run 1 /
Mean
Assay ‫االربعه يتعملم بس ال‬
, and related if present‫ال‬
SD
RSD %
CPK

Microbiology data Chemistry Results

Sampled By / date Sampled By / date

Submitted to lab By / date Submitted to lab By / date

Tested by Tested by

Recorded by /date Recorded by /date

Checked by / Date Checked by / Date

 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 6 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

Run Number : .2.

Product Name

Batch Size

Last Cleaning Date

Used Machine Diosna Capsule filling Blisering

Batch No
First bacth in campaign
Date of start / Time

Batch No

Last Batch in campaign Date of start

Date of End/ Time

NB of continuous manufacturing days

NB of manufactured batches

Production Representative

QA Representative
 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 7 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

Batches under Validation

Date of start of manufacuring process on following machine

Batch # Machine

Diosna Powder Fill Machine

Environmental Monitoring
ROOM Tempreture Humidity Diffrential pressure
Limit (----- - --------) Limit (----- - --------) Limit (----- - --------)
 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 8 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

2 PRODUCT TESTING

Testing Parameters
Run # /
Step Sample No Micro
B. NO Appearance Assay related
enum..

Run 1 /
Mean
Assay ‫االربعه يتعملم بس ال‬
, and related if present‫ال‬
SD
RSD %
CPK

Microbiology data Chemistry Results

Sampled By / date Sampled By / date

Submitted to lab By / date Submitted to lab By / date

Tested by Tested by

Recorded by /date Recorded by /date

Checked by / Date Checked by / Date

 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 9 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

Run Number : .3.

Product Name

Batch Size

Last Cleaning Date

Used Machine Diosna Capsule filling Blisering

Batch No
First bacth in campaign
Date of start / Time

Batch No

Last Batch in campaign Date of start

Date of End/ Time

NB of continuous manufacturing days

NB of manufactured batches

Production Representative

QA Representative
 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 10 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

Batches under Validation

Date of start of manufacuring process on following machine

Batch # Machine

Diosna Powder Fill Machine

Environmental Monitoring
ROOM Tempreture Humidity Diffrential pressure
Limit (----- - --------) Limit (----- - --------) Limit (----- - --------)
 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 11 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

2 PRODUCT TESTING

Testing Parameters
Run # /
Step Sample No Micro
B. NO Appearance Assay related
enum..

Run 1 /
Mean
Assay ‫االربعه يتعملم بس ال‬
, and related if present‫ال‬
SD
RSD %
CPK

Microbiology data Chemistry Results

Sampled By / date Sampled By / date

Submitted to lab By / date Submitted to lab By / date

Tested by Tested by

Recorded by /date Recorded by /date

Checked by / Date Checked by / Date

 CAMPAIGN LENGTH REPORT FOR PRODUCT Page 12 of 12
………….. on MACHINES …….
Location Solid Production Area Issue Date:xx/x/xxx
Protocol No CVP-xxx Revision no:
Report No. xxx

3 OBSERVED DEVIATION

4 COMMENTS

5 SUMMERY

6 CONCLUSION