Dr/ Ahmed M.

Yousry Ragab
QA officer
Global napi pharmaceutical plant

2. Project initiation:
2.2 Developing the business case:
Qualification is an essential part of a pharmaceutical manufacturers quality assurance system;
it should demonstrate that facilities are suitable for their intended use and should also
guarantee that the medicinal products are of an appropriate quality. Qualification is thus a
basic factor for drug product safety.
Our company, a pharmaceutical manufacturing plant is intending to buy a new tablet
compression machine to increase the capacity of the solid dosage forms manufacturing
department as these dosage forms were found to be the most profitable and desirable within
the bigger market slice.
As GMP (good manufacturing practice) requirements are legislative to our company for our
products to be FDA approved and thus be able to be exported to highly pharmaceutical
products consuming markets, qualification of equipment must be done as stated in chapter
3.34 of the GMP guide line states, manufacturing equipments should be designed, located
and maintained to suit its intended purpose. Annex 15 to the EU GMP guideline specifies
how this requirement must be implemented.
Identifying the business opportunity:
Three of our major tablet products have been FDA approved following the European EMEA
approval.
We have a great chance to export a great number of batches yearly to the USA and the
European pharmaceutical market achieving good sales and reasonable profit, together with
the local market.
The capacity of our solid dosage forms manufacturing department will not be able to satisfy the
new requirement of production so top management have decided to buy a new tablet
compression machine.
Before buying the tablet compression machine the quality assurance department manager
informed the production manager that such step needs to pass through all the stages of
qualification as stated in the GMP manual and in the FDA and EMEA requirements manuals.
Qualification procedure consists of 4 steps:
Design qualification DQ
Installation qualification IQ
Operation qualification OQ
Performance qualification PQ
Production manager informed the QA department manager and the chairman that the new
tablet compression machine is needed to start production within 3 months maximally starting
from the 1st of April 2009 to satisfy the market needs, fulfill the assigned contracts and not to
face penalties
Assessing the available options:
The available options for Qualifying the tablet compression machine is to:
1Outsourcing the Qualifying process to an external company.
2Doing the qualification using companys personnel, body of knowledge, experience,
knowhow and time.

Quantifying the benefits:

The benefits that may be derived from the right and complete qualification of the new tablet
compression machine:
Table 2.1 Business benefits
Benefit Category

Benefit description
New revenue generated

Financial

Reduce losses due to modifications

after installation

Benefit Value
About 70000000 LEs
yearly
N/A

Improved operational efficiency

Enhance Quality of product
FDA approval
Greater market share
EMEA approval
Improved Customer satisfaction
Increased customer retention

About 15000000 LEs

yearly
N/A
N/A
N/A
About 40%
N/A
N/A
N/A

Greater customer loyalty

N/A

Staff

Increased validation and

qualification in-process knowledge

N/A

Exporting image

Effect on the image to the importer

N/A

Increased profit margin

Operational
Market

Customer

By using an outsourced company to do the qualification required we will lose the staff gains as
they will not be able to do the upcoming qualifications as they didnt afford the knowledge and
the knowhow.

 Forecasting the costs:

The costs will actually differs from the toll and the full manufacturing of the effervescent
products.
This will be described as follows.
Table 2.2 Business costs
Expenses
type

Full project Costs

people

salaries

Physical

Project office
Cultural change, lost
work due to the taken
hours from the project
team

Organizational

We will not have any full timers

in this project, all the project
team members will be part
timers with assigned tasks to
perform, the overall hours cost
of all the team, manager,
review group will be of about
10000 LEs
Overall cost of 5000 LEs

CAPEX

N/A

OPEX

OPEX

By using an outsourced company there will be no different types of costs, there will be only one
fixed cost stated in the contract and is due payable only one time after the last stage of the
qualification and after providing all the needed documents and certificates, by using an
outsourced company, sources can be more controllable and within limits (stated in the
contract) and no failures responsibilities or costs will be held by our company.

The top management ordered that the full implementation of qualification by the companies own
personnel is more feasible than the outsourcing as the deliverables can be more controlled.
Assessing feasibility:
A feasibility studies may need to be undertaken to identify the likelihood of each solution
satisfying the business problem or the opportunity.
Table 2.3 Solution feasibility
Solution
Feasibility
method of feasibility
component
rating
By reviewing all models with all the new technologies on
New
the internet, asking companies to provide us with
9
technology
complete description of the features provided in the
compression machines.
No new people were recruited or depended upon as we
new
9
use already recruited staff having the knowledge that we
people
need.
Few new processes will occur due to the little differences
New
8
that will occur between this qualification process and the
process
last qualification done to the old compression machine.
New
Normal and within budget limits as no new assets needed
8
assets
out of the project office needs.
Identifying the risks:
Summarizing the most apparent risks associated with the adoption of each solution.
Table 2.4 Business risks
Risk description
Inability to recruit
skilled resources
Failure to choose
reasonable machine
Failure to provide
complete design
qualifications

Risk
likelihood

Risk
impact

Low

High

low

High

high

low

Action required to mitigate the risks

Complete the required staff members
and training
Thorough market analysis/collection of
user requirements
Analysis of the old compression
machine and adding the features you
need to be present and the
imperfections needed to be absent

Solution ranking:
Table 2.4 Solution Ranking
Assessment
Solution1 (full
criteria
manufacturing)

Solution 2
(Toll manufacturing)

Costs
people
Physical
Organizational

6
5
9

7
5
6

9
9

5
6

6
6
5

8
6
8

Benefits
increased
revenue
Reduced
expenditure
Improved efficacy
Enhanced Quality
RISKS
Resources
technology
organizational

Total score
71
69
The table shows that the recommended solution will be the implementation of the qualification
by the companies own efforts.
Documenting the issues:
Table 2.5 Business issues
Issue description
Required capital expenditure
funds have not been budgeted
Qualification procedures in the
GMP manual are not enough
Not enough experience within
our midline personnel
More time is needed to perform
complete-steps qualification

issue
priority

Action required to resolve the issue

high

Request for approval

low
medium
low

Request for more detailed procedures

from the FDA and the EMEA
Ask the advice of the higher
management line personnel
More time is asked from the project
sponsor

List of assumption:
1. There will be no change in the GMP requirements.
2. There will be no change in the FDA requirements.
3. There will be no change in the EMEA requirements.
4. There will be stability in the purchasing, quality assurance and engineering
department.
5. Additional resources will be available from the business as required.

2.3 Under taking the feasibility studies:

Through undertaking a detailed assessment of a current business problem or opportunity:
Table 2.7 Business requirements
Business opportunity
Project requirement
Design, install, operate,
Complete and fully document design qualification
measure the performance of a
Complete and fully document installation
new compression machine in
qualification
conformance with the GMP
Complete and fully document operational
manual, the FDA requirements,
qualification
the EMEA requirements
Complete and fully document performance
qualification
Identifying the solution risks:
Listing the apparent risks associated with the implementation of each solution.
Table 2.8 Solution risks
Risk description
Features and options
are many and we
cannot clearly define
what exactly we do
need
The FDA requirements
define certain qualities
and options that we
cannot afford
Upon completing
operational
qualification, the work
produced isnt meeting
the goals
Upon completing the
performance
qualification it is
discovered that the
premises in the
manufacturing room
are not enough or
stable
Documents provided
from the manufacturing
site were not
enough/complete/right

Risk
likelihood

Risk
impact

Action required to mitigate the risks

Low

low

Define precisely the main and

primary features needed

Medium

high

low

High

high

medium

Define precisely the budget offered

to buy the compression machine on
basis of the future revenues
expected
Review the goals u need with the
manufacturing and the RandD
department, perform factory
acceptance test at the
manufacturers premises.

high

Review the premises needed by the

machine from the start of the
purchasing stage and these
premises must be completed by the
time the machine parts reach the
factory.

low

The manufacturing company is

asked to send a soft copy of the
documents via the mail before the
hard copy to review them by the
quality department and the
engineering department before
accepting them or asking for
modifications

Prioritizing the solution risks:

Risk description
Upon completing the
performance qualification
it is discovered that the
premises in the
manufacturing room are
not enough or stable
The FDA requirements
define certain qualities
and options that we
cannot afford
Upon completing
operational qualification,
the work produced isnt
meeting the goals

Risk
likelihood

Risk
impact

Action required to mitigate the risks

high

high

Review the premises needed by the

machine from the start of the purchasing
stage and these premises must be
completed by the time the machine parts
reach the factory.

Medium

high

Define precisely the budget offered to

buy the compression machine on basis
of the future revenues expected

low

High

Documents provided from

the manufacturing site
were not
enough/complete/right

medium

low

Features and options are

many and we cannot
clearly define what
exactly we do need

Low

low

Review the goals u need with the

manufacturing and the RandD
department, perform factory acceptance
test at the manufacturers premises.
The manufacturing company is asked to
send a soft copy of the documents via
the mail before the hard copy to review
them by the quality department and the
engineering department before
accepting them or asking for
modifications
Define precisely the main and primary
features needed

Solution feasibility:
Table 2.10 Solution feasibility
Full
manufacturin
Criteria
g
score 1
Quality of
9
deliverables
Change
control
Work within
budget
Achieving
requirement
s
Achieving
process
understandi
ng
Retrieving
knowledge
expertise
Total Score

Weigh
total

Weight
total X
Score

Toll
manufacturin
g score2

Weigh
total

Weight
total X
Score

30

270

30

240

15

135

15

105

15

90

15

135

30

270

30

240

20

180

20

120

20

180

20

120

20
1265

140

20
1140

180

2.4 Establishing the terms of references:

After the identification of the business case and the feasibility studies for the preferred
solution the definition of the scope can be established
Identifying the project vision:
To complete and document an overall qualification of a new tablet compression machine
The project objectives:
To deliver a stepwise complete and documented qualification of a new tablet compression
machine according to the GMP/FDA/EMEA requirements in a period starting from the 1 st of
April 2009 till the end of June 2009.

Scope:
The project is to start at April 2009 and ends at June 2009.
Table 2.11 project deliverables
Deliverables
Components
Purpose of the equipment/facility
Legal requirements:
laws/regulations/standards
Design requirements: technical
data/construction and
workmanship/accessories and spare
parts(balance, code readers,
components)/materials of product contact
part
Requirements of the installation: dimensions,
environmental conditions (rooms, energy,
utilities, HVAC, safety, environment)
Performance data: list of
products(specification, in particular
dimensions, special features)/description of
the sequence of operation (flowchart,
variability of the process conditions)/ pulse
frequencies, quantity produced/setting-up
Design
times
Qualification
Facilities for control, regulation and
measurement
Requirements for maintenance, cleaning,
and care
Evidence for functionality of equipment
Requirements for the accompanying
documentation: technical document, CE
certificates of conformity, calibration and
gauging certificates, operating instructions,
certificates of materials, spare parts list,
quality certificates for software, documents
for training and instruction of staff
Customer service
Necessary supplementations and
modifications following award of contract
Installation schedule at premises of contract
giver
Documents that verify the installation of
equipments, pipes, supply facilities and
instruments following check against current
engineering drawings and specifications
Documents that verify compilation and
Installation
comparison of operating procedures as well
Qualification
as maintenance requirements of the supplier
Documents that record the requirements for
calibration
Documents of verification of construction
materials
Operation
QUALIFICATION PROTOCOL:

Description

To conform and document

the conformance of the
design with the
gmp/FDA/EMEA
requirements

To conform and document

the correct implementation of
the aforementioned
requirements when
assembling and setting up of
the facility

To conform and document

Function of the equipment/facility with

cross reference to necessary
operating instructions or company
internal operating procedures

Cross reference to risk analysis

Requirements for calibration

Parameters and associated

acceptance criteria to be checked

Directions for carrying out and

evaluating the test including the
necessary procedures

Qualification

QUALIFICATION REPORT:

Performance
Qualification

Calibration status

Results of the qualification tests

carried out

Comprehensive interpretation and

evaluation of all tests

Evaluation of deviations

Release of equipment following

successful completion of qualification

Results of the first pilot batch of the product

A against the batch record
Results of the first pilot batch of the product
B against the batch record
Results of the first pilot batch of the product
C against the batch record

That the facility is functioning

on the basis of established
parameters and within
defined limits

To demonstrate and
document that facilities and
equipments as connected
together can perform
effectively and reproducibly
based on the approved
process method and product
specification

Description of the project organization:

Listing the customers who are intended to use the deliverables produced by the project.
Table 2.12 project organization
Customer

Customer representative

Production department (internal)

Production staff members who will use the tablet

compression machine

FDA registration office (external)

FDA registration officer who will audit the Qualification

documents

EMEA registration office

(external)

EMEA registration officer who will audit the qualification

document

Quality Assurance department

(internal)

Quality assurance personnel who will document control

these documents

Project stakeholders:
Listing the persons or entity outside the project that have a key interest or stake in the
project.
Table 2.13 Project Stakeholders
Stakeholders interest
Stakeholders
CEO

Alignment with company vision

Financial controller

Alignment with company budget

EMEA

Alignment with EMEA requirements

Government body

Compliance with the ministry of health legalization and standards and

requirements

FDA

Alignment with FDA requirements

Roles:
Identifying the roles required to undertake the project
Table 2.14 project roles
Resource
Role
Organization
name
Giving technical
Engineering
information about
Engineering
supervisor
engineering issues
Giving technical
information about
Production
pharmaceutical
Production
supervisor
manufacturing
issues
Assessing
information given
and ask for
Quality
Quality
information needed
assurance
assurance
and state the
supervisor
requirements
needed to be fulfilled
Collect needs and
requirements,
perform market
Purchasing
purchase
search, do feasibility section head
studies, contact
manufacturers
Project Charter organization:

Assignment
status

Assignment date

assigned

1-APR-2009

Assigned

1-APR-2009

Assigned

1-APR-2009

Assigned

1-APR-2009

Project plan Milestones:

Table 2.16 Project milestones
Milestone title
Date
Ordering the
End of April 2009
compression
machine
Installation of the
End of May 2009
compression
machine
Operating the
Mid of June 2009
compression
machine
Production of the
End of June 2009
first three pilot
batches
Project dependencies:
Table 2.17 dependencies
Project activity
Impact on
Ordering the
Receiving the
compression
equipments
machine
Installation of the
Completing the
equipments
IQ
Producing the 1st
Completing the
pilot batch
OQ

Resources Plan:
Table 2.18 Project resources
Role
Start date
Installation engineer
1-APR-2009
Production pharmacist
1-APR-2009
Purchasing section
1-APR-2009
head
QA supervisor
1-APR-2009

Description
The creation of the purchase order/ordering
the premise from the manufacturer
The assembly of the equipment in the
production room
Testing the variables of the machine and its
ability to achieve required results
Analyzing the produced product against
limits

Is impacted by

Criticality

Date

Completing design
qualifications

High

May 2009

Receiving the
equipments

High

June 2009

Completing the IQ

High

June 2009

End date
Jun-2009
Jun-2009
May-2009

%effort
Part time
Part time
Part time

Jun-2009

Part time

Financial Plan:
Table 2.19 Project finance
Expenses
type

Full project Costs

people

salaries

Physical

Project office
Cultural change, lost
work due to the taken
hours from the project
team

Organizational

We will not have any full timers

in this project, all the project
team members will be part
timers with assigned tasks to
perform, the overall hours cost
of all the team, manager,
review group will be of about
10000 LEs
Overall cost of 5000 LEs

CAPEX

About 3000 LEs

OPEX

OPEX

Quality plan:
Table 2.20 Project processes
Process
Time management

Description
A check list of the project steps is monthly revised

Cost management

A financial consultant review the monthly project expenses

Quality management

Quality assurance revise the steps of project by the view of

Quality

Change management

The Changes that Would occur in other departments as the

production department and the warehousing

Risk management
Issue management
Procurement
management
Acceptance
management

A risk plan is made for the project steps

the project team monthly issue the project steps
The project team monthly issue the requirements of the
procession in that project
The team define certain acceptance limits for each step in the
project

Communications
management

A Certain method for the communication of the team members

and other departments is developed

List of all project considerations:

Project Risks:
Table 2.21 Project risks
Risk description
Upon completing the
performance qualification
it is discovered that the
premises in the
manufacturing room are
not enough or stable
The FDA requirements
define certain qualities
and options that we
cannot afford
Upon completing
operational qualification,
the work produced isnt
meeting the goals

Risk
likelihood

high

Medium

Risk
impact

Action required to mitigate the risks

high

Review the premises needed by the

machine from the start of the purchasing
stage and these premises must be
completed by the time the machine parts
reach the factory.

high

Define precisely the budget offered to

buy the compression machine on basis
of the future revenues expected

low

High

Documents provided from

the manufacturing site
were not
enough/complete/right

medium

low

Features and options are

many and we cannot
clearly define what
exactly we do need

Low

low

Review the goals u need with the

manufacturing and the RandD
department, perform factory acceptance
test at the manufacturers premises.
The manufacturing company is asked to
send a soft copy of the documents via
the mail before the hard copy to review
them by the quality department and the
engineering department before
accepting them or asking for
modifications
Define precisely the main and primary
features needed

Project issue:
Table 2.22 Project issues
Issue description
Required capital expenditure
funds have not been budgeted
Qualification procedures in the
GMP manual are not enough
Not enough experience within
our midline personnel
More time is needed to perform
complete-steps qualification

issue
priority

Action required to resolve the issue

high

Request for approval

low
medium
low

Request for more detailed procedures

from the FDA and the EMEA
Ask the advice of the higher
management line personnel
More time is asked from the project
sponsor

2.5Appointing the project team:

A team is appointed for this project that is formed of:
1. Project team leader (QA department manager).
2. Production supervisor pharmacist.
3. Engineering department supervisor.
4. Quality assurance supervisor.
5. Purchasing department section head.
Setting up the project office:
The project team have to meet once weekly for the discussion of the last update in the project
status.
Office equipment:
1- Desktop computer.
2- Phone.
3Printer and photocopier.
4Internal phone line.
5Internet access point.
6Intranet access point.
Communication Equipment:
Video conference tools must be present for the dealing with the machines and the equipments
and material suppliers, also is required for the dealing with the mother companies for more
and easy information transfer.
3. Planning phase:
3.2Creation of the project plan:
The project milestones:
Table 3.2 Project milestones
Milestone
Completion of user
requirements specifications
(URS)
Choosing the best offer from
the best supplier

Description
Milestone date
Compiling up of all the
20 April 2009
pharmaceutical and
technical requirements for
the equipment
After performing a thorough
30 April 2009
market analysis, market
surveys. Offers are received,
reviewed. Then feasibility
study is done to choose from
different suppliers, the

Completion of the Factory

Acceptance Tests (FAT)
Delivery of the equipments
to the manufacturing plant

Completion of Site
Acceptance Tests (SAT)
Completion of the
installation Qualification
Completion of operation
qualification

Completion of performance
qualification

supplier chosen is asked to

send the machine
specifications, then a design
review is done to compare
between specifications and
requirements. If the result of
the design review is
acceptable, a contract is
signed
Tests to confirm acceptance
at the suppliers premises
The release of the machines
from the receiving marine
and the approval of entrance
to the manufacturing plant
through the governmental
side
Tests done to confirm
acceptance after delivery to
the pharmaceutical
manufacturing plant
Tests done to confirm the
right and complete
assembling and setting up of
the facility
Tests done to ensure that
the facility is functioning on
the basis of established
parameters and within
defined limits
Tests done to ensure that
the facilities, systems and
equipments as connected
together can perform
effectively and reproducibly
based on the approved
process method and product
specification.

15 May 2009
5 Jun 2009

10 Jun 2009

12 Jun 2009

24 Jun 2009

29 Jun 2009

The project activity:

Table 3.3 Project Activities
Phase
Activity
Project planning
Complete URS

commissioning

Complete DQ

Description
Complete a
document which
defines all the users
pharmaceutical and
technical
requirements for the
equipment.
The job is put out to
tender, quotations
are compared,
decisions are made,
the order is place and
final acceptance is
carried out
Completion and
documentation of all
the design
qualification
requirements

Perform FAT

Tests to confirm
acceptance at the
suppliers premises

Perform SAT

Tests done to confirm

acceptance after
delivery to the
pharmaceutical
manufacturing plant
To conform and
document the correct
implementation of the
aforementioned
requirements when
assembling and
setting up of the
facility
To conform and
document That the
facility is functioning
on the basis of
established
parameters and
within defined limits
To demonstrate and
document that
facilities and
equipments as
connected together
can perform

Perform IQ

Perform OQ

Perform PQ

Sequence
After the procurement
decision have been
taken by the top
management

After completion of
the URS and its
approval by all the
users

After commissioning
step has been
completed and
original documents
have been delivered
by the manufacturer
After commissioning
step has been
completed and after
the approval of the
manufacturer
After the delivery of
the whole facility and
its installation
During the installation
of the facility

After performing and

completion of the IQ

After performing and

completion of the OQ

effectively and
reproducibly based
on the approved
process method and
product specification

Project tasks:
Table 3.4 Project tasks
Phase
Activity
Project planning
Complete DQ

Task

Involving
different areas of the
company to produce
informal requirement
profile of the new
facility

Describe
requirements ,
process, product
capacity

Describe the
agreement with the
contract acceptor
regarding
implementation and
handling

Describe the
requirements of the
contract giver for the
scope of supply and
service

Transfer
requirement profile
into user requirements

Sequence
1st

2nd

3rd

4th

5th

Qualify and test

user requirements

6th

Thorough market
analysis is done to
know what offers are
available

7th

Performing
supplier qualification

8th

User requirements
are dispatched to
suitable supplier
Supplier compile
technical specification
on the basis of the
used requirements
and forward this to the
prospective customer
Then these Technical

9th

10th

specifications are
compared with the user
requirements and the
GMP requirements. If
the technical
specification
corresponds with the
user requirements;
factory acceptance test
11th
is done to make sure
that the user
requirements are
compiled with at the
manufacturers
premises

Perform SAT

Perform IQ

review the
documentation of the
design phase

12th

Purchase contract is
concluded

13th

Completion and
documentation of all
the Tests done to
confirm acceptance
after delivery to the
pharmaceutical
manufacturing plant
Implementation of
the design
qualification
requirements when
assembling the facility
is documented in IQ

Visual examination
is done to the
delivered components
to ensure fault free
workmanship, correct
assembly, correct

1st

1st

2nd

setup, correct
implementation of all
utility connections and
connection with
upstream and
downstream
machines
All deviations during
installation is
documented to be
assessed for the need
of a defect list with
responsibilities and
deadlines, the results
are then listed in a
final report and
comprehensively
checked once again

3rd

Method of testing
and acceptance
criteria must be
defined prior to start

1st

Perform OQ

Perform PQ

Practical tests
are done to
check each
function in detail

Implementation
of disinfectants
and maintenance
work should be
checked at this
stage

Results of the first

pilot batch of the
product A against the
batch record
Results of the first
pilot batch of the
product B against the
batch record
Results of the first
pilot batch of the
product C against the
batch record

2nd

3rd

1st

2nd

3rd

Project efforts:
Table 3.5 Project effort
Task

Involving different areas of the

company to produce informal
requirement profile of the new facility

Describe requirements , process,

product capacity

Describe the agreement with the

contract acceptor regarding
implementation and handling

Describe the requirements of the

contract giver for the scope of supply
and service

Transfer requirement profile into

user requirements

Qualify and test user requirements

Thorough market analysis is done

to know what offers are available

3 hours

2 hours

3 hours

3 hours

5 days

4 hours

Performing supplier qualification

User requirements are dispatched

to suitable supplier

Supplier compile technical

specification on the basis of the used
requirements and forward this to the
prospective customer
Then these Technical specifications are
compared with the user requirements
and the GMP requirements. If the
technical specification corresponds with
the user requirements;

factory acceptance test is done to

make sure that the user requirements
are compiled with at the manufacturers
premises

review the documentation of the

design phase

Efforts
5 hours

1 day

3 days

2 days

1 day

7 days

2 days

Purchase contract is concluded

 Completion and documentation of all

the Tests done to confirm acceptance
after delivery to the pharmaceutical
manufacturing plant
Implementation of the design
qualification requirements when
assembling the facility is documented in
IQ
Visual examination is done to the
delivered components to ensure fault
free workmanship, correct assembly,
correct setup, correct implementation of
all utility connections and connection
with upstream and downstream
machines
All deviations during installation is
documented to be assessed for the need
of a defect list with responsibilities and
deadlines, the results are then listed in a
final report and comprehensively
checked once again

Method of testing and acceptance

criteria must be defined prior to start

3 days

3 days

4 hours

3 days

1 day

Practical tests are done to check

each function in detail

3 days

Implementation of disinfectants and

maintenance work should be checked at
this stage

1 day

Results of the first pilot batch of the

product A against the batch record

1 day

Results of the first pilot batch of the

product B against the batch record

1 day

Results of the first pilot batch of the

product C against the batch record

1 day

Project resources.
Table 3.6 Project resources
Task

Involving different areas of the

company to produce informal

Resources position
QA manager and QA supervisor

requirement profile of the new facility

Describe requirements , process,

product capacity

Describe the agreement with the

contract acceptor regarding
implementation and handling

Describe the requirements of the

contract giver for the scope of supply and
service

QA supervisor
Production supervisor, engineering
supervisor, purchasing section head

Purchasing section head

QA supervisor

Transfer requirement profile into user

requirements

Qualify and test user requirements

Thorough market analysis is done to

know what offers are available

Performing supplier qualification

QA supervisor, engineering supervisor,

production supervisor

Purchasing section head

Purchasing section head

Purchasing section head

User requirements are dispatched to

suitable supplier

Supplier compile technical

specification on the basis of the used
requirements and forward this to the
prospective customer
Then these Technical specifications are
compared with the user requirements and
the GMP requirements. If the technical
specification corresponds with the user
requirements;

factory acceptance test is done to

make sure that the user requirements are
compiled with at the manufacturers
premises

review the documentation of the

design phase

Supplier to purchasing to QA supervisor,

production supervisor, engineering supervisor

Production supervisor, engineering

supervisor, QA supervisor

QA supervisor, QA manager

Purchasing section head

Purchase contract is concluded

Completion and documentation of all the

Tests done to confirm acceptance after
delivery to the pharmaceutical
manufacturing plant
Implementation of the design
qualification requirements when
assembling the facility is documented in
IQ

QA supervisor
Production supervisor
Engineering supervisor
Engineering supervisor, production
supervisor, QA supervisor

Visual examination is done to the

delivered components to ensure fault free
workmanship, correct assembly, correct
setup, correct implementation of all utility
connections and connection with
upstream and downstream machines

QA supervisor, engineering supervisor

All deviations during installation is

documented to be assessed for the need
of a defect list with responsibilities and
deadlines, the results are then listed in a
final report and comprehensively checked
once again

QA supervisor

Method of testing and acceptance

criteria must be defined prior to start

Production supervisor, QA supervisor

Practical tests are done to check each

function in detail

Production supervisor, QA supervisor,

engineering supervisor

Implementation of disinfectants and

maintenance work should be checked at
this stage

Production supervisor, QA supervisor

Results of the first pilot batch of the

product A against the batch record

Production supervisor, QA supervisor

Results of the first pilot batch of the

product B against the batch record

Production supervisor, QA supervisor

Results of the first pilot batch of the

product C against the batch record

Production supervisor, QA supervisor

Project dependencies:
Table 3.7 Project dependencies
Activity
Depend on
Completion of user
Requisition of user
requirements specifications
requirements
(URS)
Choosing the best offer from Completion of user
the best supplier
requirements
Completion of the Factory
Performing feasibility study,
Acceptance Tests (FAT)
supplier qualification,
comparing between technical
specifications and user
requirements
Delivery of the equipments to Completion of FAT and
the manufacturing plant
signing contract
Completion of Site
Delivery of the equipments
Acceptance Tests (SAT)
Completion of the installation Delivery of the equipments
Qualification
Completion of operation
Completion of the installation
qualification
Qualification
Completion of performance
Completion of operation
qualification
qualification
Assumptions:
The project will not change in the scope.
The resources identified will be available upon request
Approved funding will be available upon request
Creation of the resources Plan:
The list of resources:
Human resources
Engineering department:
Engineering supervisor
Purchasing department:
Purchasing section head
Production Department:
Production supervisor
Quality assurance Department:
Quality assurance supervisor
Quality assurance manager
Equipments
printer
laptop
desktop
Internet access point
Microsoft windows
Microsoft office
Materials
paper
ink
electricity

Dependency type
End to start
End to start
End to start

End to start
End to start
End to start
End to start
End to start

Labor Listing:
Table 3.8 labor listing
Role

No

Project
manger

Engineering
supervisor

Purchasing
section head

QA
supervisor

Production
supervisor

Summarized
Responsibilities
Delivering the
approved solutions
to meet the full
requirements of
the customers
Provide technical
support
Purchasing,
supplier
qualification,
commissioning,
feasibility studies
Fulfilling
qualification
requirements
Provide technical
support,
pharmaceutical
production
knowledge

Summarized Skills

Start date

End date

Time management,
Cost management
Quality management
People management

1st of April
2009

30th of Jun
2009

Installation
experience
Technical problem
solving
Commissioning
experience, feasibility
study experience

1st of April
2009

30th of Jun
2009

1st of April
2009

15th of May
2009

Experience in
qualification, solid
dosage form
pharmaceutical
production
Experience in
challenging tests,
broad knowledge of
the compression
machines variables

1st of April
2009

30th of Jun
2009

1st of April
2009

30th of Jun
2009

Equipment Listing:
Table 3.9 equipment listing
Item
No Purpose
Printer and
1 To print and
photocopier
photocopy needed
documents

laptop

desktop

Internet access
point

Intranet access
point

Microsoft
windows suite
Microsoft office
package

2
2

For the project

manager to follow up
and manage the
project from inside
and outside the office
For the QA
supervisor to manage
the data acquired and
to produce the
required documents.
For the purchasing
supervisor to perform
complete market
analysis and to get in
touch with different
suppliers
For emailing work
colleagues asking for
information to be
provided or work to
be done
For the desktop and
the laptop
For the desktop and
the laptop

Specification
high speed black
and white laser
printer integrated
with high speed
economical
photocopier
Light weight, high
speed processor

Start date
1st of April
2009

End date
30th of
Jun 2009

1st of April
2009

30th of
Jun 2009

High speed, with

LCD screen

1st of April
2009

30th of
Jun 2009

512 kbps,
secured

1st of April
2009

30th of
Jun 2009

100 Mbps,
secured

1st of April
2009

30th of
Jun 2009

Vista

1st of April
2009
1st of April
2009

30th of
Jun 2009
30th of
Jun 2009

Start date
1st of April
2009
1st of April
2009
1st of April
2009

End date
30th of Jun
2009
30th of Jun
2009
30th of Jun
2009

2007

Material listing:
Table 3.10 Material Listing
Item
Component
Amount
paper
Pack of 500 sheets 2
Laser printer filling
cartridge
Ink cartridge

Cartridge enough
for 1000 papers
Cartridge enough
for 1000 papers

1
1

Resources schedule: Table3.11 Resources schedule

Attached in a separate paper

3.4 Creation of the financial plan:

Forecast of the costs:
Listing the labor within the project and specifying their unit cost:
Table 3.12 labor costs
Role
Unit cost
Project manger
300L.E Per day/ 37.5 per hour
Engineering supervisor
80L.E Per day/ 10 per hour
Purchasing section head
160L.E Per day/ 20 per hour
QA supervisor
80L.E per day/ 10 per hour
Production supervisor
80L.E per day/ 10 per hour
Listing the Equipment required for the project:
Table 3.13 Equipment costs
Equipment item
Printer and photocopier
laptop
desktop
Internet access point
Microsoft windows package
Microsoft office package

Unit cost
1500 L.E
4500 L.E
2000 L.E
48 L.E per month
350 L.E
300 L.E

Listing any administration costs that are Associate with the costs of the project:
Table 3.15 Administrative costs
Material Items
Unit cost
Paper package of 500 sheets each
19 L.E each
Laser printer filling cartridge
150 L.E each
Ink cartridge
150 L.E each
The expenses Schedule is prepared the months from Feb. till sep. 2008:

Table 3.17 Expenses schedule:

Attached in a separate paper.

Month
Jun.

Jul.

Aug.

Sep.

Week
Expenses type
Labor
Project manger
Engineering supervisor
Assistant technician
(mechanical)
Assistant technician For
utilities
Researcher for the new
product formulae
Production supervisor
Registration specialist
Equipment
Compression machine with
the associated tools power
consumption
Preparation machine with the
associated tools power
consumption
Single Punch machine for
the researches with the
associated tools power
consumption
Separate PC for the
effervescent production room
Special HAVAC System for
the Production rooms power
consumption
Administration Fees

Total
m

1200
640

1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200
640 640 640 640 640 640 640 640 640 640 640 640 640 640 640

3
1

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

264

264

264

264

264

264

264

264

264

264

264

264

264

264

264

264

640

640

640

640

640

640

640

640

640

640

640

640

640

640

640

640

1
6

120

120

120

120

120

120

120

120

120

120

120

120

120

120

120

120

120

120

120

120

120

120

120

120

80

80

80

80

120

120

120

120

Registration of the single

product regulatory fees
The taxes and fees for the
entrance of the machines in
the production plant
Shipment fees
Hosting of the foreign
consultants fees
Total

20000

5
2000

2000 2000 2000

24984 4984 4904 4904 3264 3264 3184 3184 3424 3424 3424 3424 3424 3424 3424 3424

3.5Creation of the quality plan:

First of all the identification of the deliverables and the quality criteria for the project and the
identification of the quality targets;
Table 3.19 Quality targets
Quality targets
Project requirements
Project deliverables
Quality criteria
Quality standards
Complete and right
1. Design
Review the
FDA requirements
compression machine
qualification
deliverables to
GMP requirements
qualification
2. Installation
check that all the
EMEA
qualification
requirement are
requirements
3. Operation
present and all
qualification
protocols are
4. Performance
completed:
qualification
DQ tested
and reviewed
IQ tested and
reviewed
OQ tested
and reviewed
PQ tested
and reviewed
Quality assurance plan is under taken to provide the customer with assurance for the quality
targets specified above will be met.
Table 3.20 Quality Assurance Plan
Q.A Plan
Technique
Description
Frequency
Under taking the quality
We will review the quality
Monthly
review
deliverables by:
Monthly review the project
deliverables.
Appointing the project manager
who is responsible for the
quality of the deliverables
produced by the project.
Under taking the change
Will undertake and review the
Throughout the project
control
changes that may occurs in the
manufacturing plant for the
installation and the performance
of the machines in there
specified rooms
Under taking the review for Review of the validation of
Throughout the project.
the quality validation.
installation and performance
and operation also the
validation of cleaning in the
methods of cleaning of the of
the machines after each
product.

Page
37

 Quality control plan.

Q.C is defined as the curative steps taken to eliminate the any variance in the quality of the
deliverables produced from the quality target sets.
Table 3.21 Quality control Plan
Q.C Plan
Technique
Description
Frequency
Phase review
At the end of each project
At the end of each project
phase the formal phase review
mile stone
will be undertaken
Documentation review
Review all the project
Throughout the project.
documentation at the end of
each phase
3.6 Creation of the risk plan:
The plan is created through the identification of the risks and the categories of the risks.
Referring to the table number:
3.22 Risk List
3.23 Risk likelihood
3.24 Risk Impact
The table 3.25 of the risk priority could be obtained

Page
38

 Creation of the risk schedule:

Table no: 3.26 Risk Priorities:
Risk ID

Likelihood

Impact

Priority

Rating

1.1

20

80

50

medium

1.2

20

100

60

medium

1.3

40

60

50

medium

2.1

60

80

70

high

2.2

40

60

50

medium

2.3

80

80

80

high

3.1

60

40

50

medium

3.2

40

40

40

low

3.3

40

40

40

low

4.1

60

60

60

medium

4.2

60

60

60

medium

4.3

40

100

70

high

5.1

20

80

50

medium

5.2

20

80

50

medium

5.3

60

80

70

high

6.1

20

80

50

medium

6.2

20

60

40

low

6.3

20

80

50

medium

7.1

60

60

60

medium

7.2

60

60

60

medium

7.3

60

60

60

medium

8.1

20

40

30

low

8.2

40

40

40

low

8.3

80

80

80

high

9.1

20

60

40

low

9.2

40

100

70

high

9.3

20

80

50

medium

10.1

60

80

70

high

10.2

20

100

60

high

11.1

60

80

70

high

11.2

60

80

70

high

11.3

40

60

50

medium

Page
39

By sorting the upper tables the High rating of the risk priority are:
Risk ID
Likelihood
Impact
Priority
2.1
60
80
70
2.3
80
80
80
4.3
40
100
70
5.3
60
80
70
8.3
80
80
80
9.2
40
100
70
10.1
60
80
70
10.2
20
100
60
11.1
60
80
70
11.2
60
80
70

Page
40

Rating
high
high
high
high
high
high
high
high
high
high

A Risk Schedule as follows:

In the table 3.27:
Risk
Preventive
Rating
ID
action

high

high

high

high

high

high

Action
resource

Action
date

2.1

Clearly
identify the
business
benefits

Project
sponsor

20-Mar2009

2.3

Clearly
identify the
business
benefits

Project
sponsor

20-Mar09

4.3

Specify
certain
accountant
for the
recording of
the project
spent

Project
manger

20-Mar09

5.3

Review after
each step
the output
obtained
and
comparing
with the
customer
requirement

Project
manger

After
each
step

8.3

9.2

Tracing the
delivery of
the
procurement
and there
arrivals
Review after
each step
the output
obtained
and
comparing
with the
customer
requirement
with the
addition of
the obvious
and clear
market
survey of
the product

Project
manger

Project
manger

Action
resources

Action
date

Project
manger

20-Mar2009

Project
manger

20-Mar09

Project
manger

15-Mar09

Quality
assurance
officer

During
each
step

20-May
-09

weekly
inquiry from
the supplier
by the status
of the orders

Project
manger

Starting
from 1apr-2009

After
each
step

In process
control for
the project
steps to
insure that
the project
output will
reach the
customer
requirements

Quality
assurance
officer

During
each
step

Page
41

Contingent
Actions
Measure the
actual
business
benefits
achieved by
the project
Measure the
actual
business
benefits
achieved by
the project
Outsourcing
of a finance
company for
the
monitoring of
the project
budget
In process
control for
the project
steps to
insure that
the project
output will
reach the
customer
requirements

Ratin
g

high

high

Ris
k ID

Preventive
action

10.
1

Through the
weekly
meetings

10.
2

Weekly
report to the
stakeholders

high

11.
1

high

11.
2

Action
resourc
e

Action
date

Contingent
Actions

Action
resources

The
establishment
Starting of the intranet
Project from the for the ease of
Project
manger first of
communicatio
manger
march
n through the
team
members
The
attendance of
Starting
stakeholders
Stakeholders
Project from the
representative representative
manger first of
s in the
s
march
weekly
meetings

Testing the
staff at the
beginning of
Out sourcing
Starting
the project for
or hiring partProject from the
the
timers for the
manger first of
assurance of
project time
march
the
only
Qualification
in the project
Ensuring the
overcoming
presence of
the shortage
Starting
all the
of the
Project from the
equipments
equipments
manger first of
at the
through the
march
beginning of
outsourcing or
the project
hiring

Page
42

Action
date

At the
beginnin
g of April

Starting
from the
first of
march

Project
manger

At the
beginnin
g of April

Project
manger

At the
beginnin
g of April

3.7Creation of acceptance plan:

The first step is to identify the acceptance criteria through defining first the milestones and
the deliverables then the identification of the standers to meet the customer acceptance.
Table no. 3.28 Acceptance Milestones
Milestones
Deliverables
Milestone title
Description
Name
Description
Ordering the
The approval of the
Complete design
The design
compression machine purchasing manger
qualification
qualification is a
and the CEO on the
document that
purchasing of the
verify the
compression machine
conformance of
the design with the
gmp, FDA, EMEA
requirements
Installation of the
Starting of the
Complete installation
Installation
compression machine installation phase of
qualification
qualification is a
the compression
document which
machine after all the
verify a complete,
constituents are
stepwise, right
delivered
installation of the
compression
machine
Operating the
Start operating the
Complete operational Operational
compression machine compression machine qualification
qualification is a
after being installed
document that
and empowered
verify that the
facility is operating
on the basis of
established
parameters and
within defined
limits
Production of the first
Producing three
Complete
Performance
three pilot batches
complete batches of
performance
qualification is a
three different
qualification
document that
products and
verify that facilities
comparing the results
equipments and
with the standards
systems as
connected
together can
perform effectively
and reproducibly

Page
43

Table 3.29 Acceptance criteria

Deliverable
Complete design qualification

Complete installation
qualification

Complete operational
qualification

Complete performance

Criteria
Purpose of the equipment,
facility
Legal requirements
Design requirements
Requirements for the
installation
Performance data
Facilities of control,
regulation and
measurement
Requirements of
maintenance, cleaning, care
Evidence of functionality of
the equipment
Requirements of the
accompanying
documentation
Customer service
Necessary supplementation
and modifications following
award of contract
Installation schedule at
premises of contract giver
Installation of equipment,
pipes, supply facilities and
instruments following check
against current engineering
drawings and specifications
Compilation and
comparison of operating
procedures as well as
maintenance requirements
of the supplier
Requirements of the
supplier
Verification of construction
materials
Calibration status
Results of the qualification
tests carried out
Comprehensive
interpretation and evaluation
of all tests
Evaluation of deviations
Release of
equipment/facility following
successful completion of
qualification
Results of the first pilot
Page
44

Standards
FDA requirements
EMEA requirements
GPA requirements

FDA requirements
EMEA requirements
GPA requirements

FDA requirements
EMEA requirements
GPA requirements

FDA requirements

qualification

batch of product a
Results of the first pilot
batch of the product b
Results of the first pilot
batch of the product c

EMEA requirements
GPA requirements

After the determination of the milestones and there standards and the criteria of acceptance
the acceptance schedule can be established.

Page
45

Table 3.29 Acceptance Schedule

Completion
Deliverables
milestone
Ordering the
Complete design
compression
qualification
machine

Date
30 Apr
2009

Acceptance
review
Review the
orders and the
specification
mentioned in it

Installation of
the
compression
machine

Complete
installation
qualification

12 Jun
2009

Review
installation
against
instructions

Operating the
compression
machine

Complete
operational
qualification

24 Jun
2009

Testing the
operation against
requirements

Production of
the first three
pilot batches

Complete
performance
qualification

29 Jun
2009

Comparing the
manufactured
product against
batch record

Reviewers

Date

Project
manager Q.A
officer
Production
supervisor
Engineering
Supervisor
Project
manager Q.A
officer
engineering
supervisor
Engineering
Supervisor,
Production
supervisor,
QA
supervisor
Engineering
Supervisor,
Production
supervisor,
QA
supervisor

1 May
2009

12 Jun
2009

24 Jun
2009

29 Jun
2009

Assumptions and Risks;

1-There will be no change in the project requirements during the project.
2-Acceptacne criteria will not change during the project.
3-The reviewers will be available to conduct the review.
4-The resources allocated to undertake the acceptance review may not be appropriately
skilled to complete each review that is required.

Page
46

3.8Creation of the communication plan:

Identification of the communication requirements:
First a list for the stakeholders:
1-Project sponsor (CEO)
2-Project manger
3-Project members
a. Production supervisor
b. Engineering supervisor
c. Quality assurance supervisor
d. Purchasing section head
Then listing the requirements of the communication for each member in the project:
Table 3.31 Communication requirements
Stakeholder
Information Requirements
Project
Project Status (budget, Scope)
Sponsor
Project
Project Status (budget, Scope)
manager
Detailed knowledge of the risks and list of assumptions
Information regarding the proposed changes
Project
Project Status activities that a required from each member
members
Quality
Progress of deliverables against the quality standards.
manger

Page
47

Building a communication Schedule:

Table3.32 Communication schedule
I.D Event
Description
Purpose
1
Project team Meeting
To keep the
meetings
involving all
team informed
team
for the status
members
and the issues
and risks
2
Quality
Meeting
To insure that
reviews
discussing
the progress is
meetings
the progress achieving the
in the project quality goals
against the
Quality
standards
3
Customer
Held with the To provide the
acceptance
customer to
controlled
meetings
obtain the
acceptance of
final
the deliverables
acceptance
and ensure that
the customer
requirements
are met
4
Status report Report the
To keep all the
status of the stakeholders of
project and
the project
the schedule informed for the
status.
5
Supplier
Regular
To provide with
performance meeting with the supplier
meetings
each
performance
supplier to
and resolve the
discuss the
supplier issues
performance

Page
48

Method
Verbal

Frequency
Weekly

Date
During the
months from
march 2008
till June 2008

Verbal

Monthly

Beginning of
each month
from the
march till
June

Verbal

Following
the
deliverables
completion

After the
deliverables
completion At
the end of
June 2008

Status
report
send be
electronic
mail
Verbal

Weekly

During the
months from
march till
June.

Monthly

During the
months from
march 2008
till June 2008