Project Charter of Pharma Industry 23

Every Pharmaceutical project requires a Project Charter. It is drafted in the early stages of the project by the Project owners and formally authorizes or approves the project, appoints the Project team with the project leader. A Project Charter is brief information regarding the new pharma plant establishment. It serves as a contract between the Pharma project owner, Stakeholders, and the Project team, providing a shared vision and understanding of the expected outcome. This Pharma Project Charter has a detailed scope of work, Key Assumptions, Dependencies, Stakeholders, Project Benefits & Risks, Deliverables, Timelines, and Milestones are all outlined in the Pharma Project Charter.

:::::::::::::::::::::::::::::::::::::::::::::::::::PROJECT CHARTER:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Project Name: Pharmaceutical Plant(Short description if any)

Revision Index:  Revision                 Date                                           Revision History
00                       DD/MM/YYYY                               Draft For Review

Executive Committee for the Pharma Plant Project: 

  1. Project Introduction
  2. Project Timelines
  3. Scope/Requirement
  4. Theoretical Background
  5. Regulatory Requirement.
  6. Capex/Budget
  7. Change Control Mechanism
  8. Assumptions & Exclusions.
  9. Suggestions/Recommendations
  10. Bibliography

Pharma Project (Drug manufacturing & Basic drug categorization details like liquid syrup, OSD, Ointments, Injectables, oncology, Vaccines, hormones, etc. must be in the project charter.

Production Capacity: ( 1 Bn Tablet, Quantity of injection per year, per day, etc.) Overall capacity details.

Product Names:

Pipeline Volume:

  • Brief about the location & geographical data.
  • Site Plan.
  • At least a five-year forecast.
  • Key drivers.
  • Budget or CAPEX cost.
  • Profitability.
  • Payback or ROI.
Sr. No Details Target Completion Dates
1. Design Completion DD/MM/YYYY
2. Mechanical Completion DD/MM/YYYY
3. Completion with validation & handover DD/MM/YYYY


Scope/Requirement: –

The scope limits represented in this Chart have always been based on the approved scope, and any variances or deviations in scope, cost, and timelines must be approved by relevant authorities and articulated to all project stakeholders to be mentioned in the project charter.

Scope Proposal Table with Compete Detail:
A. Pharmaceutical Plant details little brief.
1. CIVIL & allied works: 

·         Site survey.

Facility/Plant Conceptualization Layout                                          Designing

·         Architectural concept & all drawings.

·         All Layouting & designing.

·         Foundation, Structural & all civil design.

·         Building details & area with all floor plans.

·         Flooring details.

·         Internal development like Cleanrooms.

·         External development (Like Roads & drainage systems etc.).

2 HVAC : 

·         Air handling unit details their design & procurements.

·         All area classification, Temperature, relative humidity, and Differential pressure grading requirements.

·         System Control & display requirements like BMS systems.


·         Contract demand calculation & approvals.

·         HT line design & installation.

·         LT lines & panel design & installation.

·         Fire alarm System.

·         Smoke & other control systems.

·         Earthing work.

·         Lighting (Internal/External).

·         Distribution panels, cabling, power point, switch sockets, etc.

·         Door Interlock with buzzer system for all airlocks.

·         Biometric Access for main entry & other critical areas.


·         HT yard with VCB & Transformer.

·         DG sets with synchronization panels.

·         UPS with a battery bank.

·         Low tension Distribution Panels.

·         Chiller with TR capacity

·         Cooling tower with primary & secondary pumping

·         Boiler for steam with capacity.

·         Air Compressor with Dryer.

·         Water system with Purified Water system (with capacity) Panel & control system will be Compliance with 21 CFR Part 11 compliance. Online conductivity, TOC & flow meter is with online quality control instruments.

·         Water for injection generation, storage & distribution system.

·         Pure Steam generator.

·         Nitrogen plant.

·         Effluent treatment plant (ETP), and sewage treatment plant (STP).


·         Process equipment & specifications are as per the list.

·         Like OSD production equipment.

·         Injectable production equipment.

·         Warehouse equipment

·         Packing equipment.

·         Quality control Lab instruments.

·         Quality assurance department instrument.

·         Microbiology lab instrument & equipment.


·         All types of the Fire suspension system

·         Fire hydrant system.

·         Sprinkler system.

·         Fire Extinguishers & safety signages.

·         Emergency exists.

7 IT

·         All network racks with required Hardware.

·         Computers & all It instruments & equipment.

·         Server & data storage systems.

·         Laptop/desktop/software’s/licenses with Printers cum scanner etc.


·         Office with types of Furniture.


Theoretical Background:

Brief about the geographical condition where this pharma plan will make. Express the organization’s previous pros & prone in the project charter.

Regulatory Requirement.:

Describe the market regulator for which you planned to establish this pharmaceutical plant. All targeted markets have different regulations. Like if your market is the US then USFA regulation will comply with your plant. If your market is Europe Eu regulation 7 their guidelines will comply, you’re in your plant.


The approved Capex form will be attached.

Change Control Mechanism:

Any minor change in scope, their adjustment doesn’t affect the project’s overall cost or schedule, the user must nonetheless get finance controller permission.

If a change in scope during project execution has an impact on project costs, the user must submit a separate Capex request with a timetable, and obtain senior management approval.

Change Request Form Template will attach.

If you require this document in word form, please contact us at

Assumptions & Exclusions.

Describe if any which are considered theoretical & real values come after actual evaluations.

Contingency Plan:
Plan Description Who Performs Cost / Schedule / Quality / Scope Impact



A suggestion/Feedback Template will attach.


Brief about your corporate bibliography, like organization ethics, goals, motto, product details, CSR activities, etc.


Project Charter Key Points: 

A project charter is a high-level document that outlines the purpose, objectives, scope, and stakeholders of a project. The main milestones of a project charter typically include:

  1. Project objectives: The project charter should clearly define the objectives of the project and what the project team is trying to achieve. This includes identifying the business need or opportunity that the project addresses.
  2. Scope: The project charter should define the scope of the project, including what is included and what is not included in the project. This helps to ensure that the project team has a clear understanding of what is expected of them.
  3. Deliverables: The project charter should identify the deliverables that will be produced as part of the project, as well as the expected outcomes and benefits of the project.
  4. Milestones: The project charter should identify the key milestones that will be used to measure progress and determine whether the project is on track.
  5. Schedule: The project charter should include a high-level project schedule that outlines the major activities and milestones of the project.
  6. Stakeholders: The project charter should identify the stakeholders involved in the project, including project sponsors, team members, and external stakeholders.
  7. Risks and assumptions: The project charter should identify the major risks and assumptions associated with the project, and outline how these will be managed.

Overall, the main milestones of a project charter are designed to provide a clear and concise overview of the project, its objectives, and its key components. This helps to ensure that all stakeholders have a shared understanding of the project and what is expected of them.


Note: If you have any queries or feedback or you thinking about the setup of a New Pharmaceutical formulation  plant please feel free to contact:

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