Standard Operating Procedure (SOP) for Site Master File

SOP Number: [Insert SOP Number]

Effective Date: [Insert Effective Date]

Review Date: [Insert Review Date]

1.0 Purpose:

This SOP defines the procedures for the creation, maintenance, and management of the Site Master
File (SMF) to ensure compliance with regulatory requirements and facilitate communication with
regulatory authorities.

2.0 Scope:

This SOP applies to all personnel involved in the development, review, approval, and maintenance of
the Site Master File within [Company Name].

3.0 Responsibilities:

The Quality Assurance Department is responsible for overseeing the creation, review, and
maintenance of the SMF.

Relevant departments shall provide accurate and up-to-date information for inclusion in the SMF.

Regulatory Affairs shall ensure that the SMF is compliant with applicable regulations and guidelines.

4.0 Procedure:

4.1 Creation of SMF:

The Quality Assurance Department shall initiate the creation of the SMF.

Relevant departments shall provide accurate and comprehensive information, including facility
details, quality systems, and regulatory compliance data.

4.2 Review and Approval:

The completed SMF shall be reviewed and approved by authorized personnel within the Quality
Assurance and Regulatory Affairs departments.

4.3 Maintenance of SMF:

The SMF shall be maintained and updated as needed to ensure that it reflects the current status of
the facility and operations.

Any changes or updates shall be documented and reviewed by the Quality Assurance Department.

4.4 Communication with Regulatory Authorities:

The SMF shall be made available for inspection by regulatory authorities as required.

Responses to regulatory queries or requests for information shall be coordinated through the
Quality Assurance and Regulatory Affairs departments.

5.0 Records:

All records related to the SMF, including the SMF itself and any updates, shall be maintained as
controlled documents in accordance with company policies and regulatory requirements.

6.0 Training:

Personnel involved in the creation, review, approval, and maintenance of the SMF shall receive
training on this SOP as part of their onboarding and ongoing training requirements.

7.0 References:

[List any relevant references, documents, or regulations]

8.0 Revision History:

[List all revisions and their respective dates]