Forming a Team for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for forming a team dedicated to the development of analytical methods, ensuring the team comprises individuals with the necessary skills and expertise.

2) Scope

This SOP applies to the selection and formation of teams for 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 formation of the analytical method development team.

4) Procedure

1. Team Leader Selection:
   1. Identify a qualified team leader with relevant experience in analytical method development.
   2. Obtain approval for the team leader from senior management.
2. Team Member Identification:
   1. Identify potential team members based on required skills and expertise.
   2. Consider members from various departments such as analytical chemistry, quality assurance, and regulatory affairs.
3. Team Formation Meeting:
   1. Conduct a meeting with selected team members to discuss project objectives and individual roles.
   2. Ensure all team members understand their responsibilities and the project’s timeline.
4. Documentation:
   1. Document the team formation process, including team member selection criteria and roles assigned.
   2. Maintain records of all meetings and communications related to team formation.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Team Leader Approval Form
• Team Member Selection Criteria
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

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

8) SOP Version

Version 1.0