Initiating an Analytical Method Development Project

1) Purpose

The purpose of this SOP is to define the procedure for initiating an analytical method development project, ensuring all necessary steps are taken to begin the project efficiently and effectively.

2) Scope

This SOP applies to all personnel involved in the initiation of analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all team members involved in the initiation of an analytical method development project.

4) Procedure

1. Project Proposal:
   1. Submit a project proposal form to the project manager.
   2. Include project objectives, timelines, and required resources.
2. Project Approval:
   1. The project manager reviews the proposal for feasibility and resource availability.
   2. Obtain necessary approvals from senior management.
3. Project Kick-off Meeting:
   1. Organize a kick-off meeting with all stakeholders.
   2. Discuss project objectives, roles, and timelines.
   3. Assign specific tasks and responsibilities.
4. Documentation:
   1. Document all discussions and decisions made during the kick-off meeting.
   2. Circulate the meeting minutes to all participants.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to the initiation of analytical method development projects.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Project Proposal Form
• Approval Sign-off Sheet
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q8: Pharmaceutical Development
• FDA Guidance for Industry: Analytical Procedures and Methods Validation

8) SOP Version

Version 1.0