Creating a Plan for Analytical Method Development

1) Purpose

The purpose of this SOP is to describe the process for creating a comprehensive plan for the development of analytical methods, ensuring that all necessary steps, resources, and timelines are clearly defined.

2) Scope

This SOP applies to all personnel involved in the planning 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 personnel involved in the creation of the analytical method development plan.

4) Procedure

1. Project Objective Definition:
   1. Clearly define the objectives and goals of the analytical method development project.
   2. Ensure alignment with overall project goals and regulatory requirements.
2. Resource Identification:
   1. Identify the resources required for the project, including personnel, equipment, and materials.
   2. Ensure availability of identified resources before project initiation.
3. Timeline Development:
   1. Develop a detailed timeline outlining key milestones and deadlines.
   2. Include buffer periods to accommodate unforeseen delays.
4. Task Assignment:
   1. Assign specific tasks and responsibilities to team members.
   2. Ensure that all team members understand their roles and deadlines.
5. Risk Management Plan:
   1. Identify potential risks that may impact the project.
   2. Develop mitigation strategies for each identified risk.
6. Documentation:
   1. Document the project plan, including objectives, resources, timeline, task assignments, and risk management strategies.
   2. Maintain records of all planning meetings and communications.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Project Objective Statement
• Resource Availability Checklist
• Project Timeline
• Task Assignment Sheet
• Risk Management Plan
• 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