Development of Raw Material Specifications in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for developing raw material specifications in formulation development, ensuring that raw materials used in pharmaceutical formulations meet predefined quality standards and regulatory requirements.

2) Scope

This SOP applies to all formulation development activities within the organization, covering the establishment of specifications for raw materials used in the production of pharmaceutical formulations.

3) Responsibilities

The responsibilities for this SOP include:
Formulation Development Team: Evaluating raw material requirements and establishing specifications based on formulation needs.
Quality Assurance: Reviewing and approving raw material specifications to ensure compliance with regulatory standards and quality requirements.
Procurement: Communicating raw material specifications to suppliers and ensuring that purchased materials meet defined specifications.
Regulatory Affairs: Ensuring that raw material specifications comply with regulatory guidelines and requirements.

4) Procedure

4.1 Raw Material Assessment and Selection

1. Evaluate the criticality of raw materials based on their impact on product quality, safety, and efficacy.
2. Define acceptance criteria for raw materials considering pharmacopeial standards, supplier qualifications, and regulatory requirements.
3. Document raw material assessment criteria and selection rationale for each formulation project.

4.2 Raw Material Specification Development

1. Define raw material specifications based on critical quality attributes (CQAs) identified