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 Pharmacy Practices

Legal, Regulatory and Accreditation Considerations for Specialty Pharmacies

It is critical for any healthcare institution to understand the details of applicable laws and regulations to structure its approach to specialty pharmacy practices. The first step is to do a gap analysis of state and federal regulations pertaining to specialty pharmacy services. Risk Evaluation and Mitigation Strategies (REMS) requirements for specific products must also…

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…

14+ Years of Expertise

Compliance and Validation Services Expert Spotlight

Mesa Labs’ Compliance and Validation Services expert Zach Sparks has more than 14 years’ experience in: IQ/OQ/PQ qualifications and temperature mapping of incubators, freezers, refrigerators, autoclaves, depyrogenation ovens, and lyophilizers. Cleanroom qualifications, including viable and non-viable particulate monitoring for routine monitoring and ability to determine the placement of the non-viable particulate measuring equipment to meet…

Temperature Fluctuations Result in Lost Product

Genetics Laboratory; a Case Study

A Mesa Labs’ client needed a solution to fluctuating room temperatures in their laboratory, which caused sample degradation and loss of product. The customer also needed to adhere to strict regulations requiring their assets to be continuously monitored. They turned to Mesa’s ViewPoint wireless monitoring system. To read a more in-depth account of the clients’…

Client Assets at Risk

Sample Monitoring; a Case Study

One of Mesa Labs’ clients, part of a large military installation, uses Mesa’s AmegaView wireless monitoring system to protect against product loss during power outages. AmegaView automatically calls when an asset goes into alarm, allowing our customer to react immediately. To read a more in-depth account of the clients’ needs and how Mesa experts were…

Using Digital Data Loggers?

Vaccines for Children (VFC) and Temperature Monitoring Equipment

Are you using digital data loggers? How about household refrigerator/freezers? How can you be confident that your vaccines haven’t been compromised? The Centers for Disease Control and Prevention (CDC) Vaccine Storage & Handling Toolkit aims to provide guidance on these and other questions. Published in 2014, the Toolkit discusses Vaccine Cold Chain, Transportation, Storage and Handling Plans,…

Vaccines for Children

Vaccines for Children (VFC) & Vaccine Storage

Are you using household refrigerator/freezers? How can you be confident that your vaccines haven’t been compromised? The Centers for Disease Control and Prevention (CDC) Vaccine Storage & Handling Toolkit aims to provide guidance on these and other questions. Published in 2014, the Toolkit discusses Vaccine Cold Chain, Transportation, Storage and Handling Plans, Temperature Monitoring Equipment, Best Practices…

Friday Facts - Monitoring & Measurement of Processes

Monitoring & Measurement of Processes

A manufacturing company is required to have suitable methods in place for monitoring and measuring the processes involved in their quality management system.  According to ISO 9001, “These methods shall demonstrate the ability of the processes to achieve planned results.”  Essentially, what this requirement is asking you to do is to confirm that you’re having…