Specialty Pharmacy Solutions

Applying Specialty Pharmacy Regulations When Working with Partners or Contracted Organizations

Partner models consist of a healthcare institution operating a specialty pharmacy in partnership or in contract with another entity to offer the full range of services required for an accredited specialty pharmacy. Accreditation standards are a valuable resource to healthcare pharmacy leaders to ensure that all internal and partner specific regulatory components are in place.…

Specialty Drugs & Pharmacies

Why are Specialty Drugs and Specialty Pharmacies “Special”?

Specialty drugs are distinguished by two main characteristics: cost and complexity. Specialty drugs are expensive because of their delicate nature such as limited shelf life, need for climate-controlled shipping and meticulous storage. Specialty drugs are complex because they require special handling and services, inventory management and intense administration. They also need a high level of…

Case Study – USDA Regulated Freezers

Mesa Global Services recently completed an Installation and Operational Qualification (IOQ) on two large freezers that are used for the storage of USDA regulated products.  The System Information and the electrical utility supply information for the freezers verified and documented prior to the temperature mapping of the freezers. 30 DataTrace MPRF data loggers were utilized…

What is Validation?

There are three commonly used types of validation protocols for systems and equipment: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) IQ protocols should be designed to: Record critical information applicable to the equipment, including equipment attributes such as the manufacturer, serial number, model number, equipment tag or asset number, materials of construction, and…

Differentiating Design Validation & Design Verification

Design Validation frequently gets confused with Design Verification – they are quite different processes, though.  With verification, you’re making sure that the product meets the requirements identified by customers and regulations.  Validation is where you actually build a functioning version of the product to make sure it performs as expected. In Section 820.3(z), the FDA…