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Operations Manual – Pharmaceutical Company

Drug Regulatory Authority of Pakistan

(DRAP)

Pakistan

Integrated

Regulatory

Information

Management

System

(PIRIMS)

Pakistan Integrated Regulatory Information Management System (PIRIMS)

Copyright Drug Regulatory Authority of Pakistan (DRAP) - All rights reserved i Unauthorized copy or use of this document is strictly prohibited

DOCUMENT INFORMATION

Category Information

Customer Drug Regulatory Authority of Pakistan (DRAP)

Project Pakistan Integrated Regulatory Information Management System

(PIRIMS)

Document PIRIMS – Operations Manual

Document Version 1.1

Classification level Submission

Identifier DRAP-PIRIMS-Operations Manual-02

Author(s) Muhammad Asghar, USP /DRAP Software Consultant

Approver(s) Drug Regulatory Authority of Pakistan (DRAP) /USP

Issue Date 26-Nov-2020

Distribution

1. Drug Regulatory Authority of Pakistan (DRAP)

2. United States Pharmacopeial Convection (USP)

3. All Pharmaceutical Companies of Pakistan

DOCUMENT REVIEW INFORMATION

Review Date Reviewer Name Version Reference / Evidence

DOCUMENT REVISION HISTORY

Author Date Version Description (Change made, Sec Ref, CR#)

M. Asghar 30-Oct-2020 1.1 Modification based on DRAP and

Pharmaceutical Industry Training

feedback.


Copyright Drug Regulatory Authority of Pakistan (DRAP) - All rights reserved ii Unauthorized copy or use of this document is strictly prohibited

DEFINITION OF TERMS, ACRONYMS AND ABBREVIATIONS

Term Description

ATC Anatomical Therapeutic Chemical

CAPA Corrective And Preventive Action

CDL Central Drug Lab

cGMP Current Good Manufacturing Practices

CLB Central Licensing Board

CoPP Certificate of Pharma Products

CTD Common Technical Documentation

DML Drug Manufacturing License

DRB Drug Registration Board

DSL Drug Sale License

DTL Drug Testing Lab

eCTD Electronic Common Technical Documentation

FDA Food & Drug Administration

FID Federal Inspector of Drugs

FSC Free Sale Certificate

GDP Generic Drug Product

GMP Good Manufacturing Practices

INN International Nonproprietary Name

LASA Looks-Alike, Sounds-Alike

LT Lab Testing

MoM Minutes of Meeting

NDP New Drug Product

PIRIMS Pakistan Integrated Regulatory Information Management System

PV Pharmacovigilance

QA Quality Assurance

QC Quality Control

SmPC Summary of Product Characteristics

USP United State Pharmacopeia

WHO World Health Organization


Copyright Drug Regulatory Authority of Pakistan (DRAP) - All rights reserved iii Unauthorized copy or use of this document is strictly prohibited

Figure # Figure Name Page #


Copyright Drug Regulatory Authority of Pakistan (DRAP) - All rights reserved iv Unauthorized copy or use of this document is strictly prohibited

LIST OF TABLES

Table # Table Name Page #


Copyright Drug Regulatory Authority of Pakistan (DRAP) - All rights reserved v Unauthorized copy or use of this document is strictly prohibited

LIST OF APPENDICES

Appendix # Appendix Name Page #


Copyright Drug Regulatory Authority of Pakistan (DRAP) - All rights reserved vi Unauthorized copy or use of this document is strictly prohibited

Table of Contents

OPERATIONS MANUAL – PHARMACEUTICAL COMPANY ....................................................... 1

DRUG REGULATORY AUTHORITY OF PAKISTAN (DRAP) ..................................................... 1

DOCUMENT INFORMATION ....................................................................................... I

DOCUMENT REVIEW INFORMATION ............................................................................. I

DOCUMENT REVISION HISTORY ................................................................................ I

DEFINITION OF TERMS, ACRONYMS AND ABBREVIATIONS .....................................................II

LIST OF TABLES .................................................................................................. IV

LIST OF APPENDICES ............................................................................................. V

1. Introduction ............................................................................................... 1

2. Project Overview ......................................................................................... 1 2.1.1. Client, Customer and other Stake holders ..................................... 1 2.1.2. Users /Roles.............................................................................. 1

3. PIRIMS, a kick-start .................................................................................... 2 3.1. Pre-requisites ...................................................................................... 2 3.2. Login Interface .................................................................................... 2 3.3. Licensing Module ............................................................................... 10

3.3.1. New License (Company User) .................................................... 10 3.3.2. License Renewal (Company User) .............................................. 18 3.3.3. Post License Changes (Company User) ....................................... 19

3.4. Registration Module ........................................................................... 21 3.4.1. New Registration (Company User) ............................................. 21 3.4.2. Registration Renewal (Company User) ........................................ 26 3.4.3. Post Registration Changes (Company User) ................................ 27

3.5. Inspection Module .............................................................................. 28

4. Credentials for PIRIMS ............................................................................... 30

5. Support ................................................................................................... 31


Copyright Drug Regulatory Authority of Pakistan (DRAP) - All rights reserved 1 Unauthorized copy or use of this document is strictly prohibited

1. Introduction This Operations Manual will demonstrate all types of users with complete flow of

their specific modules /areas using the graphical user interfaces (GUIs). This will be

a kick-start for a novice user to start working on PIRIMS without having much

Information Technology knowledge and education.

2. Project Overview The basic purpose of this project is to automate various functions and processes

of DRAP into a harmonized and integrated way (PIRIMS) with WHO guidelines and

FDA best practices to let the concerned stakeholder know and monitor their

routine work while giving transparency at all levels to Pharma industry and DRAP

management to evaluate the staff efficiency and quality.

2.1.1. Client, Customer and other Stake holders

Following will be the Software stakeholders:

1. Pharmaceutical Industry of Pakistan

2. Drug Regulatory Authority of Pakistan

3. Drug Testing Labs (DTL)

4. World Health Organization (WHO)

5. United State Pharmacopeia (USP)

2.1.2. Users /Roles

Following will be the core users of this PIRIMS system.

1. Pharma Industry Authorized User

2. Super Admin of PIRIMS

3. Divisional Admin

4. Director of each Concerned Division

5. Additional Director of Each Concerned Division

6. Deputy Director of Each Concerned Division

7. Additional Director of Field office

8. FID of Field Office

9. Assistant Director of Field office

10. Assistant Director of Division

11. CDL authorized user

12. DTL authorized user

13. CEO of DRAP



3. PIRIMS, a kick-start

Following are the core modules of Pakistan Integrated Regulatory

Management Information System (PIRIMS):

1. Licensing

2. Registration

3. Inspection

After successful login in PIRMIS, respective user will go to their respective dashboard

as shown below:

• Company User

Company user will go to the following dashboard after successful login:

3.1. Pre-requisites

Since it’s an online web based software system, following needs to be done before

starting working on PIRIMS:

1. Computerized electronic device (PC, Workstation, Laptop, Tablet or Smart-

phone) connected to a reasonable speed of internet.

2. Devices with Windows 10, iOS, Android will be ready to connect this

application.

3. Google Chrome is the preferred browser to get optimum results

3.2. Login Interface

User will open the browser and will type the URL to access the login page of the

application:



This will take the user to the login page of PIRIMS software as shown below in the

figure 1.0.

Figure 1.0

On login interface, user will have the following options:

• User has an option (I forgot my password) to reset the password if user has

forgotten his /her password as shown in figure 1.1

Figure 1.1



User will input the registered email and will also put the security /validation code in

the text box and will press the submit button.

An email with confirmation link will be sent to the provided email account and once

user will click on the link a new email with new password will be sent to the user’s

provided registered email. User then would be able to login by using the new

password and if required, user will also be able to change his /her password from the

PIRIMS software that will be discussed later on.

If user wants to go back to previous login page, he /she can click on the Login link

to go back to the main login page.

• If Pharmaceutical company user is not yet registered in the system, he /she can

use this option to do so as shown below in figure 1.2



Figure 1.2

Basically, this new company registration process is for a pharmaceutical company

who has not yet registered with PIRIMS of Drug Regulatory Authority of Pakistan

(DRAP). Company authorized person will use this option to get his /her company

registered with PIRIMS. Once this registration form is filled along with validation code

and submitted by company user, same application will be available with DRAP Super

Admin user who will then activate the company and at the same point and time a

new company user will be created and login credentials will be sent to the company

user who will then have access to company interface of PIRIMS software system.



• After furnishing the registered email and password, user can log into the PIRIMS

If user has furnished the accurate and registered user email and password, he /she

will be directed to the dashboard /landing page as shown below in figure 2.0

Figure 2.0

Once user is successfully logged into the PIRIMS system, following are the activities

he /she can perform:

• By clicking on the name of the user (right-top of the screen), user can perform the

following two functions as shown below in Figure 2.1 and Figure 2.2:

o Sign out from the PIRIMS

o Profile link to edit basic information of the user

▪ Change Password can also be done from Profile link.



Figure 2.1

Figure 2.2

• User can access the following quick links as shown below in Figure 2.3:

o Lock application screen

o Messages

o Notifications

o Tasks

Figure 2.3

• User can access the PIRIMS functions where he /she has been given rights

/privileges by the admin of the software. These functions can be access by

clicking on the Left Navigation Menu as shown below in Figure 2.4:



Figure 2.4

In the search area, user can find the required function from the navigation menu.

This is ideal feature when a user has access for too many functions and user

wants to access that function quickly. User will type and combination of

characters and system will show the matching option in parallel as user types in.

• Depending on the data, user can expand and collapse the screen by clicking on the

button next to the PIRIMS name on the left top side of the application as shown

below in Figure 2.5 and once Left Navigation is in collapsed mode, it will look

like as shown below in Figure 2.6.



Figure 2.5

Figure 2.6



Figure 2.7

3.3. Licensing Module

Following are all possible license application processing stages:

Draft

Submitted

Screening

Under R and I

Received By DRAP

Under Review Stage 1

Under Inspection

Under Board Stage 2

Referred Back To Company (Editable)

Referred Back To Company (Locked)

Recommended By Board Stage 3

Deferred and Closed

Approved

Mainly there are two parties involved in this flow, 1. The Company and 2. DRAP. Now

we will see the Step-By-Step flow of New License Application using the Graphical

User Interfaces (GUIs) by mentioning the interface owner role against each

interface:

3.3.1. New License (Company User)

Company will open the following interface to initiate the request:

1. From Left Navigation Menu, company user will click on the License link and

will see the following interface as shown in Figure 4.0:



Figure 4.0

Next company user will click on +License to initiate the new License request and

then user will see the following image as shown in Figure 4.1:

Figure 4.1

By default, company user will be on License Category tab, the first page to initiate

the License. In this tab, user will input the License types out of the given type. Fee of

each license is also provided against each type with option to Generate Bank

Voucher that will be paid by the company and signed and stamped copy will be

uploaded as well.

Now Company user will click on the Company Management tab where they will

provide the management details as shown in the following Figure 4.2.



Figure 4.2

User can add new row by clicking on Plus sign and can remove row by clicking on Del

button as shown below:

After Management Tab, Company user will click on Inspection tab to allow user to

input required Site verification schedule.

Figure 4.3

Upon completion of above tab where DRAP has approved the Site Verification

phase, company user will now click on Layout Plan tab of the Licensing interface

and will attach the required Layout plan in PDF format in this section as shown below



in Figure 4.4. User can see the Current Phase of the License application just above

the Save button.

Figure 4.4

Now company user will click on Sections & Machines tab and will input the related

Section Wise Machine Names and other required information in this section and will

move to the next tab as shown below:

Figure 4.5

Next tab would be Drugs & Classes where company user will click and will input the

required details which will be required in Renewal case:

Please see below Figure 4.6 to add above information:



Figure 4.6

Next tab will be for the Qualified Staff as shown in the following figure:

Figure 4.7

PLEASE NOTE:

Last thing on the Inspection form is to input the Fee Invoice No. Please note that at

the time of Site Verification phase, only one fee invoice will be visible and once

verified by online banking system, status of invoice will be shown as Paid. On all

other phases, user will input respective Invoice No. and will save and then submit

the application that will validate the fee from bank and will set the status as Paid

accordingly. This process will be for all phases of the application. Please see same in

the last tab as shown below:



Figure 4.8

Company user may also input remarks in the Applicant’s Remarks section which is

commonly available under all tabs of the form.

Along-with this, there is a list available where applicant can set the Priority of the

application. Same priority will be validated from DRAP as well.

Now finally, can either Save the application as Draft and can edit same again or

user can finally Submit the application to DRAP for next processes and same

application will become Read-Only for the applicant.

Now company user has applied for the Drug Manufacturing License. Now user will

find a newly created record in the Licensing List view interface as shown below:

Figure 4.9



Company user can now monitor the submitted application by checking the Status of

the application. Whatever proceeding is happening to the submitted application,

company user can see from this interface under Status column.



Following License could be generated once application is approved by Director after

CLB recommendations which will be available to Pharmaceutical company:

Figure 4.10



3.3.2. License Renewal (Company User)

For license renewals, company user will see the Renewable Licenses in the

License Renewal as shown below in Figure 4.11.

Figure 4.11

If Renewal application has already been submitted with DRAP then it becomes the

read-only record for the applicant as shown in below image where user tried to edit

the application again but system shows error in red.

Figure 4.12



This listing will be shown automatically based on the pre-set reminders’ frequency.

For example, a company should get a reminder for the Renewal date of the License

before 6 months of the expiry of the License. A record will be shown to the company

user in the License Renewal Listing page as shown above.

Similar flow (Except Phases) will be executed as we saw in New License section of

this Operations Manual.

3.3.3. Post License Changes (Company User)

For Post License Changes of an existing License, company user will click on the Post

License Changes from the Left Navigation Menu. A list view of existing Post

License Changes Listing page will be popped-up. On the top-right side of the

interface, click on +Post License Changes button as shown below in Figure 4.13.

Figure 4.13

Following interface will be opened when you will click on the +Post License

Changes link:



Figure 4.14

Similar flow of Post License Changes will be executed as we saw in New License

section of this Operations Manual except the phases of the licenses (Site Verification,

Layout Plan approval and Grant of DML) as applicant will send the change request of

an existing granted DML.



3.4. Registration Module

Following are all possible stages of registration application:

Draft

Submitted

Screening

Under R and I

Received By DRAP



Review Complete

Under Inspection

Under Board Stage 3

Referred Back To Company (Editable)

Referred Back To Company (Locked)

Recommended By Board Stage 4

Pricing Complete

Deferred and Closed

Approved

In Registration module, flow is initiated by a Pharmaceutical Company and then

DRAP will look into this request and will process the request as per defined SOPs.

Mainly there are two parties involved in this flow, 1. The Company and 2. DRAP. Now

we will see the Step-By-Step flow of Registration Application using the Graphical

User Interfaces (GUIs) by mentioning the interface owner role against each

interface:

3.4.1. New Registration (Company User)

Company will open the following interface to initiate the request:

From Left Navigation Menu, company user will click on the Registration link and

will see the following interface as shown in Figure 5.0:



Figure 5.0

Company user will click on the + Registration button on the top-right corner of the

Registration Listing Page.

Following interface will be shown to the company user as per the following Figure 5.1

Figure 5.1

Company user will input Registration Category tab details where user will select

the required license name and then will select the Registration Type. In Registration

type, there are three types as follows:

1. New Drug Product (NDP)

2. Generic Drug Product (GDP)

3. Drug for Import

If the intended product is based on new molecule in the country then, user will select

the New Drug Product (NDP) and if Innovator product is already in the market

then user will select Generic Drug Product (GDP). If drug is to be import by the

importer, user will select the same category.



Then user will move to Drug Info tab and will input the required information over

there as shown below in Figure 5.2

Figure 5.2

User will input data against all mandatory fields in Drug Info tab to save the record.

If there are multiple INN against a requested drug for registration, separate S-Part

will be entered in the system from the link given against each INN.

Now user will fill the CTD format based data along-with attachment, (if required) in

Document Submission (CTD) tab as shown in below figures:

Figure 5.3



Figure 5.4

To record S-Part, user will use following interface that’s available against INN name

in the Drug Info. Tab:

Figure 5.5

Company user will input the CTD structural data in the CTD data structure and

finally, company user will pay the fee and will input Invoice Number in the last tab

of the Registration application form which will be validated from the bank online

system and based on the confirmation paid fee will be acknowledged by the

system. User will then input remarks and will then Submit the record with Apply

status. Once application is submitted, it will become read-only for the company and

they will not be able to modify the submitted application.

Company user can now monitor the submitted application by checking the Status of

the application. Whatever proceeding is happening to the submitted application,

company user can see from this interface under Status column.

For all types of observations and queries, user can see in the Company

Query section of left navigation menu of PIRIMS.



Upon completion of Pricing, application will go to Director Registration who will

finally approve the registration application and thus registration work is concluded

and now company user can view the registration letter from his /her own

dashboard.

Figure 5.6



3.4.2. Registration Renewal (Company User)

For registration renewals, company user will see the Renewable Registrations in

the Registration Renewal as shown below in Figure 5.7.

Figure 5.7

This listing will be shown automatically based on the pre-set reminders’ frequency.

For example, a company should get a reminder for the Renewal date of the

Registration before 6 months of the expiry of the Registration. A row will be shown to

the company user in the Registration Renewal Listing page as shown above.

Similar flow for company and DRAP will be executed as we saw in New

Registration section of this Operations Manual.



3.4.3. Post Registration Changes (Company User)

For Post Registration Changes of an existing Registration, company user will click on

the Post Registration Changes from the Left Navigation Menu. A list view of

existing Post Registration Changes will be popped-up. On the top-right side of the

interface, click on +Post License Changes button as shown below in Figure 5.8.

Figure 5.8

Figure 5.9

Similar flow for company and DRAP will be executed as we saw in New

Registration section of this Operations Manual.



3.5. Inspection Module

Following are all possible stages for the workflow of inspection:

Draft

Inspection Scheduled

Inspection Pending

Initiated

Inspection Completed

Panel Meeting Scheduled

Panel Meeting Pending


CAPA Awaited From Company

CAPA Received From Company


Review Complete

Further Information Required

Follow-Up Inspection

Re-Inspection

Deferred and Closed

Approved

1. Once inspection is scheduled, company will be notified from PIRIMS about the

inspection schedule and they will upload Site Master File on the PIRIMS software

ahead of time for the auditors to review the attached document before inspection.

Now based on the panel decision, company will be granted GMP certificate or if there

are any Critical, Major or minor issues that were observed during inspection session,

company will be given Corrective And Preventive Action (CAPA) form that they will

have to complete in a stipulated time-frame. In this scenario, CAPA form will be filled

automatically with regard to the observation and will be sent to company by software

itself that company will complete and will send back to DRAP for their verification

process.

Following image will depict the CAPA for the company user that will be based on

Inspection report.



Figure 6.0

Later on, during next assessment /inspection of the company, same CAPA will be

verified by the inspection panel members.

Pharmaceutical company user will be able to get the GMP certificate from the list

view interface of inspections module.



4. Credentials for PIRIMS

User can access PIRIMS from the following URL:

Please ask DRAP for the user credentials to access PIRIMS.

http://www.bootntow.com/pirims



5. Support

For any technical support related to PIRIMS, user can contact the under-signed:

Muhammad Asghar

USP /DRAP Software Consultant

Cell: +92 322 5948778

Email: [email protected]

mailto:[email protected]

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