sibp project execution plan

7/28/2019 SIBP Project Execution Plan

1/11

SHANGHAI INSTITUTE OF BIOLOGICAL PRODUCTS(SIBP)

SIBPPROJECT EXECUTION PLAN

page 1 of 11


2/11

chapter 1 management summary ............................................................... .............. 3chapter 2 introduction ............................................................................................... 3chapter 3 project background...................................................................... .............. 3chapter 4 goals .......................................................................................................... 4chapter 5 execution strategy......................................................................................4chapter 6 schedule .................................................................................................... 5chapter 7 project organization.................................................................................... 6project management......................................................................................... ........ 8

chapter 8 engineering design..................................................................................... 8chapter 9 procurement plan....................................................................................... 9

chapter 10 qualification and validation.................................................. .............. ....10chapter 11 appendices......................................................................................... .... 11

page 2 of 11


3/11

chapter 1 management summary

This Project Plan has been established to give a clear understanding to all parties involved inthe project on how this project is going to be executed. The plan addresses all critical areas,which may be decisive upon the success of this project.

This plan is based on Engineering Guidelines and takes into account the special type and sizeof this project as well as the project objectives described in this plan and the available resources(time, money, personnel, etc). The execution strategy, the related activities and theauthorisations described in this document are crucial and require approval by all parties.

chapter 2 introduction

The purpose of this project execution plan is to define the principal objectives for the project withrelative priorities, specific strategies and action plans that will lead to the desired result in termsof implementing the User Requirements with regard to GEP.

The User Requirements define what has to be built (Technical Project Scope), whereas theplan defines how the project GEP is to be executed.

It is a requirement that all the participating parties, i.e. as the Owner, Engineering, Contractors,etc. agree to establish and to live with the objectives, scope of work, opportunities, criticalissues, schedules, organisations, resources, roles and responsibilities. Nevertheless, the plan isa living document that has to be updated and changed throughout the life of the project toreflect major changes in priorities, objectives, critical issues as the project progresses throughthe design and construction phases.

This plan must be approved and represents the agreement and commitment to the plan. Onceapproved, it is the Project Manager's responsibility to achieve understanding and commitment tothe plan by communicating it to the involved parties in a form that is clear, concise and readilyusable.

Preparing and updating the plan as necessary helps the Project Manager and his team to getand maintain a clear picture of the project GEP (refer to SIBP GEP SOP for details) and itsexecution strategy. At the same time, the approved plan and the Project Managers approvalauthority directive set the limits within which the project manager has full authority to make hisown and final decisions.

To the other parties, the plan serves as a tool to make sure that the project has a suitable

execution approach and that Pharma Engineering Guidelines is followed.

chapter 3 project background

The Shanghai facility is located at Fengxian district of Shanghai. Total plan area of theproduction site is 312,778 square meters. Including

the first phase: No. 103 hazardous goods warehouse, No.111 production building of BCGvaccine injection, No.112 transformation rooms, boiler rooms and engineering department

page 3 of 11


4/11

building, No.113 transformation room, boiler room and engineering department building,No.114 administration building, No.115 gate rooms A, B, C(three ones), No.116 QA, mediumbuilding, No.119 Logistics centre building, No.120 measles vaccine and mumps vaccineproduction building, No.121 rubella vaccine, varicella vaccine production building, No.122 outer packaging, dilution preparation building, No.126 gate rooms and pump rooms.

Second phase: No. 101 blood products facility, No.102 blood bank, No.104 ethanol recoveryfacility, No.105 laboratory, No.106 diagnostics production building, No.107 interferon building,No.117 logistics building(inlucdng central control), No.123 influenza vaccine production building,No.124 Rabies vaccine production building. Third phase: No.118 New Drug Pilot Plant R&DCenter and reserved production workshops.

Main products for the first phase: BCG vaccine injection, attenuated live varicella vaccine,measles, mumps and rubella attenuated live vaccines,

Main Products for the second phase: long-acting interferon, rabies vaccine, influenza vaccine,blood products, etc.

chapter 4 goals

PROJECT GOALS

1. Flexibility concerning new products and new technologies.2. Provide sufficient capacity and the right technologies to cope with the forecasted demand of

the defined product list.3. Enable smooth transfer to the new production site.4. Provide facilities that are able to met recognized quality objectives and pass inspections.5. Enable phase out of the existing Shanghai Facilities.

chapter 5 execution strategy

The execution strategy of the project includes:

1. Development of Concept Design will be based on approved User Requirements .2. Concept Design will be established. The project organization will be supported by an

Architectural/Engineering-Contractor (A/E 1) with experience in pharma facilities. Theintegrated team will be lead by SIBP. The result of the Concept Design phase (list of deliverables to be established and attached to this plan) will serve as the scope definition for the next project phase.

3. Basic and Detail Design will be accomplished by an Architectural/Engineering-Contractor (A/E 2) who will be evaluated during Concept Design. This contractor may (but not

page 4 of 11


5/11

necessarily) be identical with the A/E 1-contractor for Concept Design. The design-leadwithin Basic Design will be with SIBP. Based on the list of deliverables established in BasicDesign the contractor will perform Detail Design including the integration of supplierspackages. Detail Design of package units will be performed by the suppliers and integratedinto the design package. The design lead within Detail Design will be with the contractor.SIBP will review Detail Design progress and quality. Final acceptance of Detail Design willbe made by SIBP.

4. Detail Design and Construction of equipment (package units) will be performed bysuppliers.

5. Construction and Qualification of building and infrastructure .

Construction and Commissioning of the building including infrastructure (Sanitary, HVAC,Electrical) will be performed by a General Contractor (GC). Construction Managementservices overseen by SIBP to coordinate the GC and the suppliers of the package units.

6. Construction Management and Qualification Management including coordination of subcontractors will be performed by the SIBP approved co-ordinator.

7. Commissioning and supervision will be performed by SIBP and approved third parties

8. Qualification and supervision will be performed by SIBP and approved third parties

9. Final acceptance of work performed will be made by SIBP

10. The Technical Project Manager will ensure that all contractors employed have a clearlydefined work scope and a complete definition of applicable tools, procedures and standards.

11. In order to optimize and challenge the value of engineering third party expert(s) may berecruited for a review of critical areas.

chapter 6 schedule

OVERALL PROJECT SCHEDULE

The current project timeline is shown below:

PROJECT END DATE

Definition of the project end date for the project is the handover of the facility to the owner. Thisrequires completion of start up and commissioning and approval by local authorities. Additionalactivities will follow, e.g. Qualification, relocation of personnel, start up of product transfers, process validation, operator training, etc. which are not part of the initial project.

page 5 of 11


6/11

chapter 7 project organization

The organization chart for the phases of Project Initiation and Concept Design is providedbelow. The project is headed by XXXXXXXXX.

The organization will be revised and adapted to the new requirements when changing theproject status.

Current Project Organisation Chart

page 6 of 11


7/11

ROLES AND RESPONSIBILITIES

PROJECT OWNER Responsible for project execution conformance with approved scope and objectives.

Responsible for execution of the project according to the approved execution plans andprocedures.

Establishes the business case for the project.

Approves the user requirements, which define the scope and requirements for the project.

Establishes, together with the Technical Project Manager, the prioritized project objectives. Establishes, together with the Technical Project Manager, the Project Organization.

Assigns Owner/User Representatives to the Project Management Team (as required).

Signs-off the Transition Plan and the handover-plan of the new facility to the user.

Approves Concept Design.

TEAM LEADERS Responsible for the definition of the User Requirements, which define the scope and

requirements of the facility. Verifies/confirms process requirements, production information and impacts.

Reviews concepts and design documents.

Reviews and approves critical design deliverables.

Gives guidance on regulatory affairs.

Establishes the Transition Plan from the old into the new facility.

TECHNICAL PROJECT MANAGER Directly accountable to the Project Owner for the successful delivery of the project. Establishes, together with the Project Owner, the Project Organization.

Responsible for project design and execution including cost, schedule, quality and safety

Ensures compliance with local laws and building codes.

Manages the Engineering and Construction Contractors as well as the Engineering TeamMembers and the engineering discipline support including project approved consultants.

page 7 of 11


8/11

Responsible for Contracting, Project Controls, Project Financial Controls and ProjectReporting.

Supports establishment of user requirements and key data

Establishes the execution strategy.

Represents the Owners interests in all phases of the project and achieves the projectobjectives for cost, schedule, quality and safety.

Prepares/issues monthly project progress reports in accordance with the Project ControlsPlan.

Reports to Project Owner / Senior management, providing project status & performanceinformation on a regular basis.

Keeps costs, time schedule and technical characteristics on target as approved. Ensures appropriate consulting and provision of the necessary approvals of technical

experts, such as Quality Control & Assurance; Safety, Health & Environmental Protection,Information Technology.

project management

CHANGE MANAGEMENT

Change Management will be implemented starting from the approval or user requirements.

STANDARDS

Standards applicable for this project (e.g. industry standards, ISPE etc) will be defined asnecessary during Concept Design.

DOCUMENT AND DATA MANAGEMENT

Technical Documentation is handled according to the GEP SOP and Project Quality Planrequirements. Project documentation (electronic and hardcopies) is handled according to theProject Quality Plan.

chapter 8 engineering design

REVIEW AND APPROVAL OF DESIGN WORK

Periodic reviews of design work will be conducted to ensure compliance with the user requirements and the project objectives. The Technical Project Manager will define the reviewsto be made on an as needed basis and nominate the members of the review team.

page 8 of 11


9/11

VALUE ENGINEERING

Value Engineering will be incorporated into design reviews order to optimise the added value of this project. Focus will be on functionality requirements and the standard of technical solutions.

chapter 9 procurement plan

Procurement of package units (process equipment) will be performed by the experienced andskilled organisation of the project team. Individual Detailed Specifications will be written for eachpackage to facilitate procurement.

Procurement of remaining construction equipment/material (building + infrastructure) will beperformed by the selected construction contractor(s) in accordance with the specifications andguidelines specified in the design phases.

A detailed procurement plan will be established in the early Basic Design Phase to timely cover Long Delivery Items and to ensure coordination of procurement activities.

CONTRACTING STRATEGY

The contracting strategy for the project is based on the project execution strategy described inchapter 5. The project scope will be split into the following main contracts:

Main

Contracts

Project Phase and scope Comment

A/E Concept Design Contractor resources to be integrated intoa project organisation. Process know howand key disciplines (e.g. qualification etc)to be provided by main contractor. Allother disciplines to be subcontracted.Subcontractors to be approved by SIBP.

A/E and GC Basic Design of process,building, utilities, infrastructureand external works

Detail Design of building, utilities,infrastructure and external works

Design Coordination

Construction Management

Construction Quality Control

Qualification Management

Contractor will provide all main services for BD and DD. Missing resources will besubcontracted. Subcontractors to beapproved by SIBP.

Supervision of contractor services andfinal acceptance of work will be performedby SIBP according to execution strategy(see chapter 5).

page 9 of 11


10/11

Suppliers Detail Design of process

package units (PPU)Delivery, Construction,Commissioning & Qualification of process package units includingall critical infrastructure systems(e.g. water supply and CIP)

(Interfaces to Building/Infrastructure to be

defined in BD)

chapter 10 qualification and validation

The products produced by the facility will be launched and need to be produced according tocGMP rules. The facility and the production processes have to meet SIBP Guidelines as well asthe regulations of SFDA, WHO and other relevant agencies.

A Validation Execution Plan will be established during the basic design phase to cover allqualification and validation issues of this project and to allocate ownership of the activities andcompilation of subsequent documents.

QUALIFICATION

Resource has been assigned to the project to assure that Qualification is being performedaccording to standards and procedures and to supervise qualification work being performed bycontractors and suppliers.

On time delivery and quality of qualification work to be performed by contractors and supplierswill be safeguarded by contractual terms and conditions.

PROJECT QUALITY PLAN

A project quality plan will be established and issued during the Basic Design Phase. The major sections of the Project Controls Plan will include: Work break down structure/organisation List of deliverables of each project phase (concepts, specifications, etc) Budgeting of hours to be spent on development of the deliverables.

Project Estimates and Schedules Progress Control Change Management Reporting (e.g. project monthly report, quarterly report)

page 10 of 11


11/11

chapter 11 appendices

page 11 of 11

sibp project execution plan

Documents