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 with key stakeholders.
2. Consider stakeholder feedback and recommendations.
3. Select the strategy that best meets project objectives, regulatory requirements, and resource constraints.
4. Document the selected strategy in a strategy selection report.

4.4 Approval of the Selected Strategy

1. Submit the strategy selection report to senior management and quality assurance for review.
2. Obtain formal approval from senior management and quality assurance.
3. Communicate the approved strategy to all team members and stakeholders.

4.5 Implementation Planning

1. Develop an implementation plan based on the selected strategy.
2. Define key activities, timelines, and responsibilities for the implementation phase.
3. Document the implementation plan and distribute it to all relevant parties.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Strategy Assessment Report
Evaluation Report
Strategy Selection Report
Implementation Plan

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