Selecting Active Pharmaceutical Ingredients for Formulation Development

1) Purpose

The purpose of this SOP is to provide a detailed procedure for selecting active pharmaceutical ingredients (APIs) during the formulation development process, ensuring the chosen APIs meet project requirements and regulatory standards.

2) Scope

This SOP applies to all formulation development projects within the organization, from initial API identification to final selection and documentation.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing the API selection process and ensuring alignment with project objectives.
Team Members: Participating in the identification, evaluation, and selection of APIs.
Quality Assurance: Reviewing and approving the API selection documentation.

4) Procedure

4.1 Initial Identification of APIs

1. Identify potential APIs based on therapeutic targets and project goals.
2. Gather initial data on each identified API, including chemical properties, efficacy, and safety profiles.
3. Document the initial list of potential APIs and their key characteristics.

4.2 Detailed Evaluation of APIs

1. Conduct a detailed evaluation of each identified API, considering factors such as:
   1. Pharmacokinetics and pharmacodynamics
   2. Stability and compatibility with other formulation components
   3. Toxicity and safety data
   4. Regulatory status and compliance
2. Perform comparative analyses to identify the most promising APIs.
3. Document the detailed evaluation in an API assessment report.

4.3 Selection of the Optimal API

1. Review the API assessment report with key stakeholders.
2. Consider stakeholder feedback and recommendations.
3. Select the API that best meets the project’s therapeutic, safety, and regulatory requirements.
4. Document the selected API in an API selection report.

4.4 Approval of the Selected API

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

4.5 Documentation and Record Keeping

1. Ensure all documentation related to the API selection process is complete and accurate.
2. Maintain records of the API selection report, assessment data, and approval documentation.
3. Store documentation in accordance with organizational record-keeping policies.

5) Abbreviations, if any

API: Active Pharmaceutical Ingredient
SOP: Standard Operating Procedure

6) Documents, if any

API Assessment Report
API Selection Report

7) Reference, if any

– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0