Initiating a Formulation Development Project

1) Purpose

The purpose of this SOP is to outline the steps required to initiate a formulation development project, ensuring all necessary preparations and approvals are in place for successful project commencement.

2) Scope

This SOP applies to all formulation development projects undertaken by the pharmaceutical development team, covering the initiation phase from project conception to official project kick-off.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing the initiation process, obtaining necessary approvals, and ensuring all project resources are allocated.
Team Members: Assisting in the preparation of project documents and initial planning.
Quality Assurance: Reviewing and approving the project initiation documents.

4) Procedure

4.1 Project Conceptualization

1. Identify the need for a new formulation development project.
2. Conduct a preliminary feasibility study.
3. Document the project concept and initial scope.

4.2 Approval for Project Initiation

1. Prepare a project initiation request document.
2. Submit the request to senior management for approval.
3. Obtain formal approval and sign-off from relevant stakeholders.

4.3 Resource Allocation

1. Identify required resources (personnel, equipment, materials).
2. Allocate resources based on project requirements.
3. Ensure all necessary resources are available for project start.

4.4 Initial Project Planning

1. Conduct an initial planning meeting with key stakeholders.
2. Define project objectives, deliverables, and timelines.
3. Develop a high-level project plan outlining major milestones.

4.5 Project Kick-off

1. Schedule and conduct a project kick-off meeting.
2. Communicate project goals, timelines, and responsibilities to the team.
3. Distribute the project initiation documents to all team members.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Project Initiation Request Document
Project Approval Sign-off Sheet
Initial Project Plan

7) Reference, if any

– ICH Q10: Pharmaceutical Quality System
– FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0