Good Engineering Practice

Based on the ISPE Guide Lines

Good Engineering Practice (GEP) is defined as

those established engineering methods and
standards that are applied throughout the life
cycle to deliver appropriate and cost effective
solutions.

Generally the term is used to describe an

engineering management system that is being
applied in the engineering profession for
delivering, operating and maintaining capital
assets.

While GEP is expected in a pharmaceutical

enterprise, it is not mandated by GMP
regulations.

Risk Management

Cost Management

Organisation and Control

Risk management is at the core of the

application of Good Engineering Practice.
GEP should facilitate a balanced
evaluation of risks against benefits.

Risk Assessment methodologies should be performed

throughout the life cycle of the project. Where risks
are identified, practicable engineering efforts should
be made to design out or minimise identified risks to
an acceptable level.
At the early planning stage of the project, risk
assessment will provide options to mitigate risks to
the patient as related to the product and process
requirements, as well as risks related to operability,
and other regulatory requirements.
Subsequent risk assessments will provide
opportunities to identify and mitigate risks associated
with constructability, installation, and verification
deliverables.
Decisions related to product and process design
should be made based on science-based data, and the
results of the risk assessment and evaluation.

Cost management is a key aspect of good

engineering practice ensuring the cost
impact of any activity is understood,
assessed, and managed in order to return
good value. Value is measured as a
balance between cost, quality, and scope
of project delivery.

Initial Estimate:
A company should have a system for
clearly articulating specific business
requirements and obtaining an initial cost
estimate for a given scope of work in
order to evaluate its viability.
Throughout the course of the activity the
estimate should be updated and
expenditure tracked to predict final cost
and ensuring continuing viability.

Return on Investment (ROI):

The relationship between the costs of an activity

and the return on the investment should be
understood in order to make rational decisions to
proceed or otherwise at any stage.

The engineering function should work with the

financial and contract departments to develop
models determining contract strategy, factoring
in net present value, cost of money, and return
on investment.

The full life cycle cost of ownership including

initial capital cost, operating cost and ultimate
decommissioning and disposal cost should be
factored into any investment decision.

Return on Investment:

The relationship between the costs of an activity

and the return on the investment should be
understood in order to make rational decisions to
proceed or otherwise at any stage.

The engineering function should work with the

financial and contract departments to develop
models determining contract strategy, factoring
in net present value, cost of money, and return on
investment (ROI).

The full life cycle cost of ownership including

initial capital cost, operating cost and ultimate
decommissioning and disposal cost should be
factored into any investment decision.

Front End Loading:

A key driver of GEP is to identify and commit a

sufficient level of resources, into the planning
and conceptual design stage of a project, in
order to minimise the risk of cost and schedule
overruns in later phases. This is achieved by
ensuring clear project definition, scope of work
and a realistic project schedule are outlined
that are aligned with business objectives.

Scope Definition, initial risk assessments and

early cost evaluations activities should be the
prime focus at the conceptual design stage.

Clear Organisational Structure:

Reporting relationships and responsibilities

within an organisation should be clearly
understood and preferably documented.

The use of matrix management for particular

activity may redefine or amend the customary
relationships, so should only be used when clear
reporting lines are defined.
Monitor and Control:

There should be mechanisms set up within an

organisation to develop matrices for measuring,
communicating, and addressing any deviation
relating to quality, performance and progress of
assigned activities.

Defined Procedures:

The project team should have defined procedures

to cover the anticipated range of projects, which
include all appropriate governance procedures
either on a general or individual project.

The scope of procedures should encompass the

project organisation and reporting structure,
documentation strategy including retention and
storage, planning, progress and cost reporting,
change control appropriate to various stages and
activities, design reviews and quality control.

The scope of procedures should at a minimum

encompass:

Project organisation

Reporting structure

Documentation strategy including retention and

storage

Planning/ Scheduling, progress and cost reporting

Change Management / Control appropriate to various

stages and activities

Design reviews

Fabrication and Construction quality control

Vendor and third party/ contractor selection and

management

Testing and verification strategies

Engineering / Project Change Management

Standards and Procedures
Asset Life Cycle Management
Vendor / Supplier Management
Maintenance and Spare Parts
Calibration
Internal Audit
Waste Management
Decommissioning / Relocation

The project team should have systems for the

generation, review, approval, retrieval and
archiving of engineering documents, procedures
and records, whether paper-based or electronic.
The system should have methods to ensure the
security and integrity of documents, depending
on the assessed importance of these from a
regulatory, operational or professional
perspective.
Engineering documents should be generated
and maintained in a manner to ensure that
information contained therein is accurate clear
and unambiguous and current.

Engineering change management is defined as a process

by which qualified representatives review proposed
changes of their impact, on quality, cost and schedule
before approval or denying the requests, and then
manages, tracks, and records their implementation.
Defined processes should exist to manage both project
changes and operational changes.
A company should have a system in place to monitor
changes for example by type or location, in order to
identify trends and identify potential underlying issues
(e.g. a poorly defined design) which may benefit from an
alternative approach to the root cause for the changes.
Appropriate Subject Matter Experts should be involved in
reviewing and approving the changes.

Regulatory Assessment:

In an environment where both regulated and nonregulated assets are in use the assessment process
should define if a change has potential GMP impact
or not.

Changes with GxP impact should go through a formal

(documented) process to communicate, and evaluate
the potential impact, the intended purpose, and the
work required to implement the change.

Appropriate Subject Matter Experts should be

involved in reviewing and approving the changes.

The Quality Department should be involved in

reviewing and approving these changes.

Operational Impact:

The system for changes to existing assets

should be reviewed for potential impact on
operation and on maintenance. Where the
scope or scale of the change is significant
due consideration should be given to
managing the works through the project
engineering process rather than just as an
operational change. Where the work involves
changes to existing assets, the change
management system should also facilitate
review for potential impact on operations
and maintenance.

The organisation should have written standards and

procedures for all key aspects of GEP across the project
lifecycle. These key procedures may be collated in the form
of a Project Procedures Manual. This should include a
process for verifying, approving, issuing and retrieving
standards and procedures. More importantly, there should
be a process for ensuring that all key stakeholders involved
in delivering the project or facility are familiar with the
content and practices described. For this reason, some of
the more critical procedures may be included in the tender
packages for both vendors and trade contractors to ensure
that all parties fully understand their responsibilities in
regard to acceptable quality levels and the expected
deliverables.
There should also be a process for checking and approving,
issuing and retrieving and auditing the implementation of
these GEP standards and procedures throughout the project
lifecycle.

Review and Approval:

Standards and procedures should be maintained

current and effective, they should be reviewed and
approved by appropriate personnel.

There should be a system for issue of new and

retrieval of superseded standards and procedures.
Structure:

A structure should be in place to define the

difference between guidance and work
instructions. Work instructions should be adequate
to define practices and methods ensuring uniform
understanding and execution.

Asset management includes the

requirement for documenting, managing
and tracking the lifecycle of assets. The
project team should ensure that the
asset management requirements are
clearly defined at the outset of the
project.

Asset Register: Asset registers may exist for a number of

purposes:
Regulatory requirements
Financial accounting (auditing depreciation, general

ledger entries), and reporting.

Security and ownership verification
Maintenance and spare parts
Calibration
Equipment numbering and tagging
Turnover documentation

Equipment and tag numbering systems may exist for other

purposes, identifying process elements for calibration,
maintenance etc.
The numbers should indicate function as well as location.
The numbering scheme needs to be well understood by
stakeholders to be effective.

Strategy and Planning:

Strategic planning should include a
maintenance strategy to ensure that
equipment systems consistently
maintain their fit for intended use
status.
Production planners should summarise
the system capacities and process limits
into an equipment asset document.

Support:

All systems and equipment should

have defined, documented support
procedures whether support is done
in-house or via vendor or third party
support.

Computer Systems:

Prior to a computer system or software

package being used, it should be
assessed and recorded on an asset
register or systems register to record
its usage and status.
Where a system is used for GxP as well
as GEP then this should also be
recorded on the register.

A documented process of supplier and

vendor management should be in place to
ensure that vendor and supplier facilities
practices and standards, present an
acceptable risk to ones own company and
products.
These procedures should be consistent with
the projects quality system requirements.

Supplier Management:
A company should have a system for
continuing research and accreditation of
suppliers of services and materials
ensuring adequate quality standards are
maintained, with core suppliers and a
back-up strategy.

Audits:
A plan should be in place to cover the
routine audit of all internal engineering
functions (including projects) and key
external suppliers. Use should be
made of audit checklists to ensure
consistency of activity. These may also
be used for trend data.

Inspection:
A company should have a system to inspect
goods received against agreed
specifications.
Identification:
It is recommended that companies maintain a
spare parts inventory. Spare parts inventory
systems should identify and label spares,
materials, tools, and test equipment.
Prioritisation of spare parts should also be
managed. This may be part of an overall
asset management system to ensure that
parts are fit for their intended use.

Maintenance and Spare Parts requirements

should be understood and incorporated early
in the design.
Upon delivery and installation, equipment will
also require either Demand Breakdown (DM)
or Preventative / Predictive maintenance
whether it is in use, or out of service.

Preventative / Predictive Maintenance

Preventative maintenance (PM) provides

procedural activities such as adjusting, cleaning,
calibration, and lubricating of equipment to assure
continued performance, in accordance with
specifications.
Predictive maintenance (PdM) utilises equipment
readings to provide for routine replacement of
parts and equipment overhauls.
Operations and maintenance should be designed
to, minimise the consequences of functional failure
to product and business activities, support quality
assurance, and maximise business benefits.

Preventative / Predictive Maintenance

The project organisation should have trained

individuals available to attend to demand
maintenance (DM) promptly, record any outcomes or
change parts required and return equipment back to
use in a timely manner.
Furthermore, once the equipment is in use even
during the verification phase- routine monitoring
(rounds and readings) activities will need to be
planned for and resourced. This presents an
opportunity to get end user maintenance staff
involved early, prior to system handover and form
part of some of the formal handover training required.
Contingency plans should be in place for critical
equipment.

Preventative / Predictive Maintenance

In consideration of spare parts, plans should be

in place to deal with spare parts utilised or
required during the installation and verification
phases and also ongoing operations
requirements post handover.
Specifications for parts should be documented
to facilitate accurate reordering and to
encourage use of standardised components.
Where the end user has already established
standard components or suppliers it should be
communicated to the design team early.

Emergency Parts and Services:

The organisation should have a readily
available list of outside resources that
quickly supply spare parts, can provide
specialised repair service, or equipment
replacement.

PM/PdM Assessment:

Risk assessments help to determine the GMP

criticality of equipment. Equipment systems
determined to be critical can be further assessed
for their potential failure modes in order to
determine the affect on product quality and
productivity.

In the case of new equipment, the design review

documents may be used as the basis for the
assessment. These assessments can be used to
assist in establishing preventative and predictive
maintenance requirements, and should be
periodically reviewed against results obtained
and manufacturers recommendations.

Prioritisation- PM and PdM:

Activities should be prioritised according to
Product / Patient impact, regulatory
compliance, and productivity requirements.
Resources should be matched to these
requirements. PM/PdMs should be utilised in
concert with production needs and
calibration activity.

Maintenance Schedule and Records:

An accurate record should be maintained of all

process, utility and facility equipment entered
into the maintenance program recording the
activity and any work performed. Equipment
usage records are needed for use-based
PM/PdMs.
Procedures:

PM/PdM should be performed against

approved procedures and recorded adequately
by noting what maintenance was performed.

Demand Breakdown Maintenance:

Demand Maintenance (DM) should address breakdowns of
equipment and systems in a timely and cost effective manner.
Organisation:

A company should have trained individuals available to attend to

DM promptly and return equipment back to operational use.

Operations staffs are required to be trained in maintenance

request procedures, faultfinding and methods to address
maintenance issues.

Engineering maintenance staff will be trained for other issues

involving engineering skills or for specialised equipment needs.
Contingency plans should be in place for critical equipment.

DM Procedures:
A company should have DM procedures for expected types of
repairs.

Computer Systems:

A company should have in place trained staff

available to attend failures of computer hardware
and software.

These individuals should also perform

preventative maintenance, housekeeping,
monitoring, routine testing and housekeeping
activities.

Planning should be in place to mitigate the effects

of major system failure. This could involve off-site
storage of back-up data; redundant and high
integrity systems where appropriate.

Computer system performance monitoring is

commensurate with GEP.

Spares and Spare Parts:

A maintenance plan should consider spare parts and
spare part inventories, utilising risk assessments in
order to determine the criticality of equipment, and
requirements for PM/PdMs.

Specifications for parts should be documented to

facilitate accurate reordering and to facilitate the
use of components fit for their intended use.
Emergency Parts and Services:

A company should have a readily available list of

outside resources that quickly supply spare
parts/units, or can provide specialised repair service.
Utility Failures:

Each facility should have procedures to manage

utility failures.

The organisation should have a process in

place to ensure that all calibrated and installed
instruments will be managed by the end users
upon turnover.
The end users should have a Calibration
Quality Management System in order to
ensure that the instruments are maintained in
a state of calibration appropriate for its
function and the related risk to product quality.

Instrument Selection and Assessment:

Instrument selection and assessment activities should be
aligned with the overall Risk Assessment Process in order
to ensure that the criticality classification is determined by
a given instruments impact to the Critical Quality
Attributes or Critical Process Parameters. In some cases
instruments will be introduced into the design as a risk
control mechanism and criticality will be assigned
accordingly.
In addition to the instrument criticality assessments,
other data will be determined which will affect:

the type of instrument used for the application

the initial frequency of calibration and periodical reviewed

against performance

the instrument category e.g., Product, Process, EHS or

non-critical

the calibration range and accuracy required

In addition to the instrument criticality

assessments, other data will be
determined which will affect:
the

type of instrument used for the

application
the initial frequency of calibration and
periodical review against performance
the instrument category e.g., Product,
Process, EHS or non-critical
the calibration range and accuracy required

Other critical aspects to be accounted for

within the project procedures, in relation to
Calibration include:
Use

of third party calibrations to support

verification activities.
Format and import of, the relevant instrument
and calibration data onto the end users.
Calibration Management System.
The scheduling and resources for this activity
should also be clearly defined.
Maintaining the calibrated state throughout
the project lifecycle and the scheduling of
these activities within the project schedule.

Instrument Schedule and Records:

An accurate record is maintained of all instruments

entered into the calibration program recording the
process requirements for the instrument, calibration
activity and any adjustment. Calibration should be
scheduled in concert with production needs and
scheduled maintenance activity.
Calibration Record Review:

Records are securely stored, retained for a defined

period and evaluated periodically to ensure that the
appropriate instrumentation is in use.
Performance Review:

Data from calibration activity should be reviewed to

assess trends and drift. This should be used to
determine the frequency of calibration needed to
maintain the desired accuracy at an acceptable risk
level.

A documented process should be in place to

ensure that Good Engineering Practice is in
place as a base level in all areas and by all
parties involved in the project.
Auditing:
A plan should be in place to cover the routine
audit of all internal engineering projects, their
functions and key external suppliers, vendors
and contractors.
Use should be made of audit checklists to
ensure consistency of activity. Audits may also
be helpful for trend data.

The organisation should have an effective

system for disposal of waste products and
materials in a manner that does not
compromise business operations and meets
applicable standards for environmental
protection.
Waste Collection: The organisation should
have appropriate systems for collection / sorting
/ intermediate storage and handling of waste.
Design: Waste streams solid liquid and gas
and their appropriate disposal should be a
consideration in the design of any facility. The
need for and cost associated with waste
streams should be considered in facility design.

Environmental safety should be addressed in all

cases of hazardous or potentially hazardous
waste, e.g. containment of fire sprinklers
discharge, cytotoxic waste systems.
Treatment and Disposal: The company should
determine appropriate means of treatment and
disposal based upon risk and statutory
requirements and cost benefit. The potential
affect on Public Relations for any particular
solution should be considered.

Where a project includes the renovation or

decommissioning of facilities and equipment systems, the
organisation should have a method for decommissioning
and disposing of facilities and equipment. Before
decommissioning a system there should be an evaluation
as to whether critical, existing measuring devices need to
be re-calibrated in order to maintain the controlled state.
Facility

and Equipment Evaluation: The company

should have appropriate systems for evaluating
performance and return on investment of existing assets
against current best technologies. This should be used to
determine the need to replace / supplement / modify /
refurbish existing assets on a cost / quality / efficiency
basis.

Disposal: The organisation should have a

method of determining any environmental /
commercial / social risks associated with the
various means of disposal in order to select
the optimum.
Environmental Risks: Any potential
environmental contamination is identified and
addressed appropriately and in accordance
with prevailing regulatory requirements.

Facility and Equipment Inheritance and

Recycling: The organisation should have
systems for due diligence assessment and
management of potential acquisitions to ensure
that they are cost effective.

Recycling: The organisation should evaluate

the continuing requirement for any piece of
equipment and if its utilisation is low, consider
alternatives for its use, or disposal.
The efficiency should also be reviewed with current
technologies, and a determination made as to
the benefit of replacing/modifying/refurbishing
equipment, or recycling it to another site serving
a different market.

The company should organise their project engineering

activities according to defined procedures and processes.
The revised lifecycle approach to specification, design,
verification and acceptance, post ASTM E2500-07. The
following section outlines the typical GEP Project
Management processes and procedures recommended
for use during this project lifecycle.
Phases and Sequence
Justification Phase
Initiation Phase
Planning Phase
Project Execution Phase Verification
Turnover and Project Closure

Phases & Sequence:

Typically, phases of a project follow a logical
sequence; however in practice, some phases
may overlap and there may be some iteration
between phases. On a case by case basis,
project specific activities and deliverables will be
associated with each defined project phase.

A clear definition of these phased activities,

their purpose and the required content of the
deliverables, together with the roles and
responsibilities of each stakeholder group will
foster effective communication and help ensure
project success.

Phases & Sequence:

The user and designer should determine

suitable iterative design stages, with
increasing project definition, at which
reviews will be held. This process will enable
increasingly accurate cost and schedule
estimates and maintain quality.

The stages to review the project design will

vary according to type, scale and risk and
each stage typically requires a further
contractual commitment.

Justification Phase:

An organisation should have defined methods of

rational decision-making regarding the selection and
approval of projects based upon specific business
requirements.

This should be documented, communicated and kept

under review throughout the project lifecycle to
ensure that, as new parties are engaged, the
potential for scope creep is monitored.

Typically an initiator prepares a proposal for

management approval, based on an identified
business opportunity, with preliminary scope
statements, business benefits and timing for the
project identified.

When the project is accepted, management should

identify a suitable project sponsor to champion the
project and appoint a project manager to develop the
scope, cost estimate, and detailed business case.

Initiation Phase:
The project initiation phase typically involves the sponsor
and project manager working together to develop the
project organisation, which includes the following
activities:

Define scope of the project, outline key project

objectives and define any known milestones

Creation of the project charter

Appointment of a steering committee as needed for

major projects

Project team member selection

Development of the Project Quality Plan

Development of the Project Communication Plan

Initiate project team member selection / appointment

Official project team launch The sponsor will kick off

the first team members with an official communication
of the project charter and management expectation.

Project Approach:

The organisation should ensure that

appropriate methods, such as risk
assessments are employed to establish the
optimum project approach. The solution
should consider the full lifecycle and
associated risk of each possibility. (e.g. The
lowest initial cost option may not be optimal
due to higher operational costs or significant
risk factors.)

These decisions should be periodically reevaluated during the course of a long project.

Project Implementation:

The organisation should have a method to

determine the most appropriate
implementation model for the delivery of the
project scope, within the context of
approved / nominated budget and schedule.
Project Management Resources:

The organisation should have access to

appropriate project management resources,
experienced in implementing projects of
similar scope and scale. This will determine,
among other things, the management
structures and strategies for contracts.

Project Requirements :

The organisation should have a formal and

documented means of developing and
reviewing the user requirements. This will
serve not only to capture the fundamental and
critical aspects of the systems and facilities but
will also serve to facilitate the management of
scope and associated changes.
Good practice would involve the User as much
as possible in this process. Where resources
other than the user group produce these
documents the minimum requirement would be
a review and sign off from the user group.

Project Requirements :

All requirements should be objectively

stated such that they can be verified.
Alignment with objectives of any master
plan needs to be confirmed.
A clear delineation between the GMP
requirements and non-GMP requirement
should be documented, so that proper
interface and support of the GMP
compliance is robust and eliminate any
duplication of testing between GMP
requirements and non-GMP requirements.
GMP requirements should be communicated
with the Quality Department.

Planning Phase:

The organisation should have long-term

business strategy, which may include
formal site / company plans.
There should be a formal method of
developing a project plan to achieve the
defined objectives, reviewing them against
the company strategies / plans with a
means of monitoring project progress
against the project plan.

Planning Phase:
Long Term Strategy:

The organisation should have a long-term

business strategy, which may include formal site
master plans. These should be reviewed and
revised as required to ensure that they reflect the
commercial and political environment.
Project Planning:

The organisation should have a system for

developing an integrated project plan, defining
time lines, activities, methodologies;
interdependencies, and resource requirements.
The level of details available in these plans
should be developed as the project progresses
and methods of reporting progress against plan
should be utilised as a project monitoring tool.

Planning Phase:

Quality Planning:
The organisation should ensure quality plans are
obtained and are appropriate for the proposed
project and managed according to the agreed project
schedule. This should define acceptable standards
and how they will be achieved and assessed. For
example, this will include review stages and approval
and quality management of suppliers.

Communication Plan:

The organisation should establish regular

communications between stakeholders including the
Project Team, Vendors, and Quality Unit, project
sponsor.

Each form of communication should establish a level

of detail, regularity, confidentiality and distribution
appropriate for the task.

Planning Phase:
Procurement Plan:

The organisation should ensure that appropriate

methods are in place to assess and select vendors
based on defined project acceptance criteria, which
includes quality, costs, experience, technical support,
scope and schedule.

Within the new lifecycle model proposed, it is

recommended that the testing and verification
strategies intended to be employed for the equipment
and facilities are outlined and agreed upon early in
the design process. This will facilitate their inclusion
in the procurement and tender process.

Where possible, a representative of the SMEs, with

responsibility for the testing and verification
activities, should be included in the vendor capability
and bid assessments.

Planning Phase:
Monitoring and Control:

The organisation should have an overall

system for identifying the most
appropriate means of monitoring
progress against the plan (monies spent,
work progress, activities completed) and
predicting final cost and completion
date.

This information should be

communicated to the requisite parties.

Project Execution Phase:

Specification and Design
The conceptual design stage is used,
where necessary, to generate various
alternatives for evaluation in response to
the demands of the User Requirements
Specifications for individual systems.
The project team selects the concepts
to be taken forward into the functional
and detailed design phases.

Project Execution Phase - Design Process:

User Requirements:

While the initial set of user requirements

should be available from the initiation phase,
suitable time and resources should be
committed in this next stage of the project to
the development, documentation and
communication of those user requirements.
This will ensure greater understanding of the
project goals and definition.
These requirements should be written in
measurable terms and should be used as the
basis for developing other detailed technical
specifications and drawings.

Project Execution Phase - Design Process :

Design Phases:
The organisation and their designer should
determine suitable iterative design phases, with
increasing project definition for milestones and
reviews. This process will also enable increasingly
accurate cost and schedule estimates and maintain
quality. The design phases will vary according to
type, scale and risk and each stage typically requires
a further contractual commitment.

Design Deliverables:

The structure and level of detail in the design

deliverables will be determined by the chosen
contract strategy, acceptable degree of risk, risk
remediation options, and the size and make-up of the
project support team.

Project Execution Phase - Design Process :

Design Deliverables
Specific stage deliverables will vary according to project
but may include:

Concept drawings:
Sections; Layouts Material flow, personnel flow and
process flow.
Intermediate stage:
Development of P & IDs; preliminary equipment specs;
outline architectural drawings
Final stage:
Detail drawings, requirements specifications, and system
specifications Specific local documentation deliverables
for compliance with regulations (Such as Health & Safety,
pressure regulations etc.) and obtaining approvals.

Project Execution Phase - Design Reviews:

The project team should have a formal

system for reviewing the design at different
stages, against objectives to ensure that
adequate quality is delivered at optimum
cost.
A formalised peer review system with
appropriate experts that are outside the
project team is recommended to provide an
objective review of the designs robustness,
to ensure that the design will actually work.

Project Execution Phase - Design Reviews:

Design Quality Control:
The user should formalise with their designer a system for
quality control of drawings, specifications, and calculations
typically defined in a quality plan. This should cover:

Change management process and implementation

The application of the risk management strategy (how to
manage risks and when to perform assessments)
Document checking, review and approval before issuing at
appropriate stages. (e.g. concept, approved for design and
approved for construction)
Document numbering and version control.
Equipment and instrument identification
Design and progress reviews
Verification procedure
Document distribution and control

Project Execution Phase - Design Reviews:

Design Review Mechanism:

The organisation should define a documented method of

reviewing the project design according to type, scale, and
risk, utilising suitably skilled people including the users to
challenge the design and ensure that the declared
requirements are delivered.

The process should identify all relevant codes, regulations,

technical norms and standards that should be complied
with and formally confirm applicability and conformance.

The company should ensure that the review encompasses

all factors likely to be significant at that review stage.
Design Review Outcome:

The company should have an appropriate method of

recording and disseminating the results of the design
reviews, and managing any consequent changes. The
results should confirm the continuing suitability of the
design.

Project Execution Phase - Design Reviews:

Construction
The company should have an appropriate means of
selecting and managing the method of
construction.

Management Systems:
The organisation should have a defined means of
reviewing the options for the construction contract
strategy suitable to its type, scale, and risk.

Construction Quality Standards:

The organisation should ensure defining,

reviewing, and achieving quality standards, for all
activities undertaken during the construction
phase of the project.

Project Execution Phase - Design Reviews:

Project Site Logistics

Well-planned project logistics are crucial to

the success of every project. One of the
first deliverables from the construction
leader should be a project logistics plan.
Where the project is within an existing
manufacturing facility/ site, methods of
maintenance and monitoring cGMP
conditions of existing operations and support
areas during demolition and construction
should be established.

Project Execution Phase - Design Reviews:

Project Quality Control

The importance of Project Quality Control (QC) is

second only to safety. Quality control starts with the
pre-qualification of the appropriate suppliers,
contractors and, where applicable, the construction
management firms and their proposed project teams.
Each companys QC program should be reviewed and
evaluated, and previous project references
contacted.
The construction leader should develop a project
specific QC plan that incorporates the facility owners
requirements and procedures with those of
construction leader, e.g. the Approval to Build
procedure for construction drawings, specifications,
and P&IDs or the Mechanical Completion, walkdown
and snagging procedure.

Project Execution Phase - Design Reviews:

Non GMP Regulation Compliance

Project procedures should ensure responsibility
is assigned for formal identification and
enforcement of relevant non-GMP statutory
and regulatory codes and regulations (or
obtaining variances and waivers). This may
apply to site based construction practices,
construction tests and records as well as the
specification of equipment. (e.g. Pressure
regulations, electrical codes, CE marking,
Environmental Regulations).

Project Execution Phase - Design Reviews:

Estimating

If the majority of the project cost is for construction,

then it is recommended to have the project
manager (if contracted) participate in the budget
estimate. Otherwise, the design firm should
perform the budget estimate.

Project Execution Phase - Design Reviews:

Procurement

Throughout the Project Execution Phase, procurement

plan status reporting should be undertaken.
The reports should identify all bid packages and
proposed pre-qualified bidders.
The reports should list the scope of each bid package
along with the contract terms (e.g., lump sum, or
time and materials, which are not to be exceeded).
The projected dates for issuing bid packages, pre-bid
meetings and the bid award should be listed.
Upon award of contracts, the procurement status
reporting should include details of stage payments
completed, outstanding payments to be issued and
details of the prerequisites, deliverables or approvals
required to release each subsequent stage payment.

Project Execution Phase - Design Reviews:

Safety

The project team should develop a safety plan, which is

specific to the project, during construction planning.
This plan should incorporate the requirements of both the
construction firm and owner.
Construction safety hazard analysis reviews are needed to
identify activities that have higher than normal risk to
employees and property. Specific plans, procedures, and
training should be implemented to address the hazards
identified.
The construction firm should provide safety and job site
orientation for all employees as a pre-requisite to being
able to work on-site.
An orientation specific to the project should be developed.
The orientation of the employees should be documented.

Project Execution Phase - Design Reviews:

Meeting and Reporting

Before construction begins, the required periodic

meetings and reports should be established.
Planned reports should have agreed frequency and
distribution lists.

Project Execution Phase Project Controls

The project manager is responsible for the management

of the owners costs and should ensure that a cost
report is developed and maintained.
Budgets are
established from the initial approved estimate and are
maintained as the project is further developed.
Schedule Development and Controls

A single, integrated master schedule should be

developed with input from the entire project team. This
schedule shows the dependencies of activities and
should be updated and issued regularly.
Each month the schedule controller should verify the
percentage completion of each activity, based on
installed quantities. Verified progress versus planned
progress curves should be generated for the schedule
on a monthly basis. For larger projects, earned progress
by discipline, area and system may need to be
generated.

Project Execution Phase Project Controls

Document Planning and Control

The project manager should ensure that a

document plan and appropriate document
control procedures are established to satisfy
engineering, testing, verification, operations,
and maintenance requirements.
Procedures should provide rigorous version
control and notations, such as dating or reason
for issue (e.g., for review, for construction).
With the increased use of electronic mail for
document distribution, procedures also should
stipulate that the document controller
receives copies of project e-mails for filing.

Project Execution Phase Verification

Verification is a lifecycle activity and many of

the tasks defined in the Verification Plan will be
executed across several of the project phases.

The project manager should therefore ensure

the development and execution of the
Verification Plan as an integral part of the
overall project lifecycle.

The project manager should also establish the

framework necessary to ensure that there is no
duplication of effort in the achievement of full
compliance to GMP requirements.

Project Execution Phase Verification

Equipment / Process Verification

The primary function of the verification plan is to

ensure that those aspects of equipment or system
functionality; that have a direct impact on the safety of
patients, the product or are required by the GMP
regulations are appropriately tested, verified,
documented, and approved.
The extent of testing required will depend on the level
of the associated risks.
The risk assessments undertaken will define the
process for establishing evidence of compliance and if
any additional testing will be required to demonstrate
that the identified risks are properly addressed.
The results of certain tests performed to demonstrate
compliance of non-GMP requirements may also be used
to support GMP requirements, without duplication.

Project Execution Phase Verification

Factory Acceptance Testing

A Factory Acceptance Test (FAT) comes under the

umbrella of verification testing and is a systematic
inspection of a system or equipment item, including
all necessary documentation, before it leaves the
manufacturers works.
The FAT should provide confidence that the delivered
system meets the business and user requirements of
the final system owner.
The FAT may not be a single phase of tests executed
prior to shipment of the unit to the end users site. It
may in addition, comprise of the results of a series of
Pre - Delivery Inspections (PDIs) executed, witnessed
or reviewed throughout the fabrication period.

Project Execution Phase Verification

Site Acceptance Testing

Site Acceptance Testing (SAT) comes
under the umbrella of verification
testing and is performed upon delivery
and installation of the system or
equipment item and confirms that the
system operates as designed and
specified in its final location.

Project Execution Phase Verification

Construction Quality Inspections

Where a system is being fabricated onsite as part of

the Construction Phase works (i.e. stick built
system), there should be formal reviews by the
Verification SMEs of the application of the approved
construction quality plans and relevant GEP project
procedures, to ensure that the systems under
construction comply with the approved
specifications and requirements.
Where appropriate, the results of these inspections
or test activities will support or fulfil the
requirements of the verification plan. e.g. witnessed
slope verifications, weld inspections, NDT testing
etc.

Project Execution Phase Verification

Equipment / Process Verification

Critical aspects of manufacturing systems that

will have direct impact on product and patient
safety require additional verification testing in
order to assure that the GMPs are properly
addressed.
The extent of testing will depend on the level of
risks. The results of certain tests performed
under non-GMP requirements may be used to
support GMP requirements, without duplication.

Project Execution Phase Turnover and Project

Closure

Turnover and Project Closure

Project closeout procedures, deliverables, and

responsibilities should be clearly defined well
before construction commences.
The method of project turnover, whether
phased or a single project completion turnover
package, should be defined.
There are three key steps to the project
closure.
Technical Closure
Financial Closure
Lessons Learnt

Project Execution Phase Turnover and Project Closure

Technical Closure
Transfers the responsibility from the project team to
the owners and has them accept the
documentation.
Some items in the technical closure are:
Final project report
Certificate of occupancy
Finalised punch-list
Signed project acceptance
Subcontractor evaluation report
The owner should receive a complete set of all
original project files.

Technical Closure
Technical closure items (Cont):
The

construction firm or manager should be required to

maintain a copy of all project files for an established period,
and to notify the owner prior to properly disposing of files.
Contracts that have confidentiality agreements should
require certification of the destruction of the documents.
The owner should confirm that they have received the
agreed system turnover documentation (e.g., system
manuals). Typical documents include specifications,
purchase orders, supplier contacts list, certified supplier
drawings, approved submittals, approved punch-list, O&M
manuals, PLC and programming information, spare parts list,
warranties, calibration, and verification testing documents.

Technical Closure
Technical closure items (Cont):
As

Built drawings and specifications

Training documentation
Spare Parts
Operating and Maintenance Procedures
Maintenance Plan

Financial Closure

Closed invoices and other financial obligations

are completed and the capital account is closed.
Financial responsibility is transferred from the
project team to the owner.
Lessons Learned

A formal process for evaluating the project for

different stages and agree on what went well
and what did not go well. This typically requires
an objective facilitator and the participation of
the team members, sponsor, and
vendors/contractors. The report from lessons
learned would be available for future reference
and continuous improvement purposes.