PROTOCOL OR REPORT FLOW IN DOCHUB

 Firstly in pharma to manufacture a product we need some sop .so for making of sop
for batch record. we require some doccument making website or application called as
dochub.

 The doccuments like :- confirmatory batch record or placebo batch record or

trail batch record.

 So for this we require a pis(product information sheet),by using this they prepare that
batch record.

 Batch records are in two formats report and protocol.

 Confirmatory and exhibit →manufacturing

 Prevalidation ,.validation &commercial →validation

 By opening the dochub application click on the login.

 It asks for login id and password for a trainee person they allocate some temperary
login like:-
Login :FTOPU1_Author
Password:FTOPU1_Author

Step-1:-

 We have to create a new protocol by selecting the “create” option or” new”option appears in the
dochub website like:-
Welcome

New import content current version

Step-2:-
“Fill creation profile”

 After opening there we see some three words where we have to fill data as below

Creation profile : manufacturing

Group : protocol & report
Subgroup :protocol & report-product

Step-3:-
 After submitting above details then it moves to “edit properities”. If there is any changes you can
edit. Otherwise leave it as it is. and click on next.

Step-4:-

 Now “choose template”.means how you want a doccument format.

 It is a backend operartion in which it automatically selects it template according to data available.

Step-5:-

 Now verify that “linked doccument”.and click on next.

Step-6:-

 Now “edit content” like doc name or above mentioned data which you provided.

Step-7:-

 After completing above procedure now we have to “check in”.

Step-8:-

 Finally doccument is created. And doccument no is “PR-FS01_000039”.but documment is

empty.

Step-9 :-

 After that a window will open with some options like:-

Classification traceability documment info drug product process info

1)Classification
Firstly by opening the classification option we see as below

Title:- confirmatory protocol of glimipride.

Unit:-formulations sez pu1.

Applicable sites:-formulations sez pu1

Applicable areas:- maufacturing sciense and technology

Department:-msat

Group:-as mentioned above

Subgroup:-as mentioned above

Artifact name:-General
Hold time
Sampling
Stability
Tech transfer

Quality element:-change control

Audit & regularity
Doccumentation & data management
Facilities, utilities & equipement
Labeling & packaging systems
Process & method validation

Nature of doccument:- protocol

Report

Language:- english

Project:- nothing mentioned

Batch size:- nothing mentioned

Market:- nothing mentioned

2) Traceability

In this we see data like:-

New/revise reason: new

Quality record number:

Legacy doccument no:

Source doccument:

Source doccument no:

Notification list: cd_formulations sez pu1_coordinators

3) Doccument info:-

Version label:

Owner name:
 Format:

Full content size:

Creator name:

Modified by:

Checked out by:

Created:

Modified:

Checked out date:

4) drug product

Product code:20002110

Drug product:blend revaroxaban tablet10mg

Trade name:

Generic name:

Dosage strength:10mg

Dosage form:tablet,extended release

After completion of data click on next.

5)Process info:

Under this as we discussed about template .here we are going to select the template which we
want in for a batch process.

Choose template:

1. Bto-protocol template

2. Bto-report template

3. Common protocol validation-template

Check in:

1) Generel:
2) Name: PR-FS01-000039

3) Version label:0.1,current

Your doccument is created like sop manner .

Review flow for the created doccument

 Login as author .

 Now move the curser to docs.and then right click on the doc which we created.
Then a popup window will appear then click on “edit:”

 Then delete the garbage data on that word doccument .copy &paste the content you
want in that doc .

 After editing is completed save the doc and exit from it.

 And again go to the dochub and go to the “workflow tasklist” and refresh it and
right click on it and go for check in .

 Again right click on that doc select submit for “collaborative editing” .

 Then planning or sending of work flow window will appear .under this we have to
select the reviewers like
FTOPU1_reviewer1
FTOPU1_reviewer2

 click on send option.

 It will sent to reviewer1 according to the workflow.

 Right click on the workflow task list appears on leftside of the window &click on
the refresh option such that your doccument will appear.

 Then go to the task attachement. Which is below the workflow task list then right
click on doc and click on review & edit the consolidated copy.

 The doccument will open in wps. then you have to comment on it if there any
mistake .

 And Then click on save option to save your comments addressed.

 click on the check in option by right click on the doc appears on relations.

 check in window appears under this write description as what is commented on doc
 & click on ok.

 Then Edits complete option will appear by right clicking on the doccument appears
on the workflow tasklist.

 Then a comment window will appear then comment as reviewed and commented
and click on ok .

 Then it will disspappear from the reviwer1 workflow tasklist and it will be again
sent to author to correct the comments addressed.

 After correcting them and delete the commented addressed and click on check in. and
author will again sent to the reviewer1 by clicking on send option as above
discussed.

 if there is no mistake in the doccument .then the reviewer1 will accept the task right
clicking on the doc in the workflow task list.

 Then it will disappear from reviewer1 and it will sent automatically to reviewer2.

 if he also do the same like reviewer 1. Then again go to the author and he will correct
it and send it.

 But Again it will go from starting i.e author to (reviewer1 & reviewer2).there is a
chance to reviewer1 and reviwer2, i.e any one can address the comments first.

 after all this process it will reach to end of work flow i.e reviewe2.

 if reviewer2 is reviewed and commented that doccument .then the doc will sent to
author for further process like sop for batch record to make a medicine.

Approval flow for the created doccument