Pharmaceutical Facility Security Requirements (PFSR)

The Pharmaceutical Facility Security Requirements (PFSR) is TAPA’s official Standard for the secure warehousing and storage of pharmaceutical products. It provides a common global framework that can be referenced in business and security agreements between Buyers and Logistics Service Providers (LSPs), as well as by other Applicants seeking Certification.

In developing this Standard, TAPA acknowledges the diverse ways storage services are delivered globally, regionally, and within individual companies. The PFSR may apply to all, or only part, of the services provided by an LSP/Applicant. Depending on the complexity and scale of the supply chain, compliance may be achieved by a single LSP/Applicant, or through multiple LSPs/Applicants and qualified subcontractors.

Typical Users of the PFSR Include:

• Buyers / Pharmaceutical Buyers

• LSPs / Cold Chain Providers / Applicants

• Third-Party Logistics Providers (3PLs)

• Law Enforcement and other government agencies

• Professional Supply Chain Organizations

• Insurers

• Supply Chain Security Consultants

Difference Between FSR and PFSR

The PFSR builds on the foundation of TAPA’s globally recognized Facility Security Requirements (FSR), while tailoring the framework specifically for pharmaceutical facilities, where risks such as product integrity, counterfeit threats, and patient safety are paramount.

In addition to the baseline FSR controls, the PFSR includes requirements specific to pharmaceutical operations, such as:

• Controlled Drugs Storage Areas

• Cytotoxic Substances Storage Areas

• Pharmaceutical Dangerous Goods Storage Areas

• Redressing of Pharmaceutical Products Areas

This results in a framework that balances practicality with rigor, strong enough to mitigate critical risks, yet flexible enough to be applied across diverse markets and facility sizes. This balance is what makes the PFSR both credible and achievable.

To know more about PFSR, please Contact Us