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 changes through a formal change control process, including identification, evaluation, and implementation of changes.
2. Review and approve document changes following established procedures and ensure traceability of changes.
3. Communicate document changes to affected personnel and provide training as necessary.

4.4 Document Retention and Archiving

1. Establish document retention periods based on regulatory requirements and organizational policies.
2. Archive obsolete or superseded documents in a secure and accessible manner.
3. Maintain document archives for future reference, audits, and regulatory inspections.

4.5 Document Management System (DMS)

1. Utilize a Document Management System (DMS) to facilitate document creation, revision, approval, and distribution.
2. Ensure DMS provides version control, access control, and audit trail functionalities.
3. Regularly audit and maintain the DMS to ensure it meets organizational and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
DMS: Document Management System

6) Documents, if any

Protocols
Reports
SOPs
Change Control Records
Document Distribution Records

7) Reference, if any

– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– FDA Guidance for Industry: Data Integrity and Compliance with CGMP

8) SOP Version

Version 1.0