For pharmaceutical and medical device manufacturers, a Site Master File (SMF) is more than just a document—it’s a blueprint of your facility’s GMP compliance!
What is an SMF?
It’s a regulated document that provides an overview of a manufacturing site’s quality management system (QMS), facilities, personnel, and processes. It’s submitted to health authorities (e.g., EMA, WHO, PIC/S, and other regulators) to demonstrate compliance with Good Manufacturing Practices (GMP).
Key Components of an SMF:
- General Information – Site details, activities, and regulatory approvals.
- Quality Management System (QMS) – Overview of GMP policies, deviations, CAPA, and audits.
- Manufacturing Operations – Description of product types, processes, and validations.
- Facilities & Equipment – Cleanrooms, utilities, maintenance, and calibration.
- Documentation Systems – Batch records, SOPs, and data integrity controls.
- Personnel & Training – Roles, responsibilities, and GMP training programs.
- Outsourced Activities – Contractors, suppliers, and vendor qualification.
- Product Storage & Distribution – Warehousing, transportation, and cold chain logistics.
Why is the SMF Important?
- Supports regulatory inspections (EMA, WHO, MHRA, etc.).
- Ensures transparency in manufacturing operations.
- Helps in audit readiness and risk management.
- Facilitates harmonization across global regulatory frameworks (especially under PIC/S guidelines).
As regulatory expectations evolve, ensuring your SMF is up-to-date is critical!
Related Topics:
Resource Person: Pratik Pawar