Selecting a Formulation Development Strategy

1) Purpose

The purpose of this SOP is to outline the procedure for selecting an appropriate formulation development strategy, ensuring that the chosen strategy aligns with project objectives, regulatory requirements, and resource availability.

2) Scope

This SOP applies to all formulation development projects within the organization, from the initial assessment of potential strategies to the final selection and approval.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Leading the strategy selection process, coordinating with team members, and obtaining necessary approvals.
Team Members: Providing input and expertise during the strategy assessment and selection process.
Quality Assurance: Reviewing and approving the selected strategy.

4) Procedure

4.1 Initial Assessment of Strategies

1. Identify potential formulation development strategies based on project goals and requirements.
2. Conduct a preliminary assessment of each strategy’s feasibility, risks, and benefits.
3. Document the initial assessment findings in a strategy assessment report.

4.2 Detailed Evaluation of Strategies

1. Select the most promising strategies from the initial assessment for detailed evaluation.
2. Analyze each strategy in terms of technical feasibility, cost, timeline, and regulatory compliance.
3. Conduct risk assessments for each strategy to identify potential challenges and mitigation plans.
4. Document the detailed evaluation in a comprehensive evaluation report.

4.3 Selection of the Optimal Strategy

1. Review the detailed evaluation report