Establishing a Formulation Development Team

1) Purpose

The purpose of this SOP is to provide a detailed procedure for forming a formulation development team, ensuring that the team is composed of appropriately qualified and skilled members to achieve project objectives.

2) Scope

This SOP applies to all formulation development projects within the organization, from the selection of team members to the formalization of the team structure.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Selecting team members and defining their roles and responsibilities.
Human Resources: Assisting in identifying and onboarding team members.
Team Members: Understanding and fulfilling their roles within the team.
Quality Assurance: Ensuring team formation complies with organizational standards.

4) Procedure

4.1 Identifying Team Requirements

1. Determine the necessary skills and expertise required for the project.
2. Define specific roles and responsibilities for team members.
3. Document the team requirements in a project team plan.

4.2 Selection of Team Members

1. Identify potential team members based on their qualifications and experience.
2. Conduct interviews or assessments if necessary to evaluate candidates.
3. Select team members who meet the project’s skill requirements.

4.3 Onboarding Team Members

1. Inform selected team members of their roles and responsibilities.
2. Conduct an onboarding session to introduce team members to the project scope and objectives.
3. Provide necessary training or resources to team members to prepare them for the project.

4.4 Formalizing Team Structure

1. Develop a team structure chart detailing roles and reporting lines.
2. Distribute the team structure chart to all team members.
3. Establish regular team meetings and communication protocols.

4.5 Reviewing and Adjusting Team Composition

1. Periodically review the team’s performance and composition.
2. Make adjustments to the team as necessary to address skill gaps or project needs.
3. Document any changes to the team composition and inform all stakeholders.

5) Abbreviations, if any

HR: Human Resources

6) Documents, if any

Project Team Plan
Team Structure Chart

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