Managing Documentation in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for managing documentation effectively throughout the formulation development process, ensuring traceability, accuracy, and compliance with regulatory requirements.

2) Scope

This SOP applies to all formulation development projects within the organization, covering documentation management activities from initial document creation to final archiving and retention.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing documentation management activities and ensuring adherence to project timelines and regulatory standards.
Documentation Team: Creating, reviewing, and maintaining all formulation development documents.
Quality Assurance: Reviewing and approving documents for accuracy, completeness, and compliance.
Regulatory Affairs: Ensuring documents meet regulatory requirements and supporting submissions.

4) Procedure

4.1 Document Creation and Review

1. Create new documents (e.g., protocols, reports, SOPs) as per project requirements and templates.
2. Assign document review responsibilities to appropriate personnel, including subject matter experts and stakeholders.
3. Review and revise documents based on feedback to ensure accuracy, clarity, and compliance.

4.2 Document Approval and Distribution

1. Obtain approval from designated approvers (e.g., project manager, quality assurance) for finalized documents.
2. Distribute approved documents to relevant stakeholders and ensure access according to document control procedures.
3. Document distribution records and maintain a master list of controlled documents.

4.3 Document Change Control

1. Manage document