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 during formulation development.
2. Specify physical, chemical, microbiological, and functional attributes required for each raw material.
3. Include testing methods, acceptance criteria, and any special requirements in the raw material specification document.

4.3 Approval and Review

1. Review raw material specifications with cross-functional input from formulation development, quality assurance, and regulatory affairs.
2. Obtain approval for raw material specifications to ensure alignment with project requirements and regulatory expectations.
3. Document approval dates, responsible personnel, and any revisions made during the review process.

4.4 Supplier Communication

1. Communicate approved raw material specifications to suppliers and ensure their understanding and compliance.
2. Establish procedures for supplier qualification, auditing, and ongoing monitoring to verify adherence to specifications.
3. Document supplier communications, audits, and qualification activities to support raw material traceability and compliance.

4.5 Specification Maintenance and Updates

1. Establish a system for periodic review and update of raw material specifications based on new scientific knowledge, regulatory changes, or quality improvements.
2. Document any changes or updates to raw material specifications and ensure that relevant stakeholders are informed and aligned.
3. Archive obsolete specifications and maintain a controlled document system for current specifications.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CQA: Critical Quality Attribute

6) Documents, if any

Raw Material Specifications
Raw Material Assessment Reports
Supplier Qualification Records
Specification Change Records

7) Reference, if any

– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– USP/NF: United States Pharmacopeia/National Formulary

8) SOP Version

Version 1.0