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…

Mesa's Calibration & Validation Services

Validation Services; a Case Study

One of Mesa Labs’ clients utilized Mesa’s Compliance and Validation Services team to conduct an experiment to ensure their retort cooking process of blue crabs met regulatory requirements. By using Mesa’s MPRF data loggers to monitor and obtain critical data of their cooking operations in real time, the client was able to meet requirements and…

Ensure Regulatory Compliance

Intertek; a Case Study

One of Mesa Labs’ clients, Intertek, hired Mesa’s Compliance and Validation Services team to perform temperature mapping on their stability chambers to ensure regulatory compliance. By using Mesa’s services, the customer was able to show that all of their equipment being used for stability testing was able to meet the 21 CFR Part 211, FDA,…

Keep Your Products Safe

Benefits of Temperature Mapping

Current Good Manufacturing Practices (21CFR Part 211) require that raw materials, in-process materials, finished products, stability samples, and components are stored at the correct environmental conditions to maintain the integrity of the products and components. To meet these requirements, temperature mappings of the areas and equipment used to store your products must be completed before…

Quality Policy

Another item that is required by both 21 CFR 820 and ISO 9001 is the Quality Policy.  Though it is jointly written by management and quality experts, the process of writing a Quality Process is a beneficial exercise for management as it has them focus on systems and how the company operates.   This document…

Validation of Dry Heat Sterilization Processes

Dry Heat Sterilization is a sterilization process that can be used to terminally sterilize health care products, medical devices, equipment, components or bulk active pharmaceutical ingredients by exposing the items to a temperature of ≥ 160°C for a defined time. For heat stable items, such as glassware or stainless steel equipment, a dry heat sterilization cycle…

Validation of a Steam Sterilization Process

If terminal steam sterilization of medical devices, production or packaging components, final pharmaceutical product, or bulk active pharmaceutical ingredients is required, it is necessary that both the sterilization cycle(s) and the autoclave be validated. Validation of the autoclave and the sterilization cycle(s) is required by ANSI, AAMI, ISO, and the FDA to ensure that all…

Quality Plan

In 21 CFR 820 Subpart B, the FDA states “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.  The manufacturer shall establish how the requirements for quality will be met.” A quality plan states the goals your company has to improve…