ISO Regulations and MediZap Protocols | Newsletter | Issue 02 | 2020

ISO Regulations And MediZap Protocols

What is ISO, exactly?

The International Organization for Standardization (ISO) was founded in 1947 and consists of representatives of national standards organizations from countries around the world. Its primary purpose is to create and maintain international standards in order to ensure safety, fairness, and efficiency in international trade, and proper regulatory guidance in a wide variety of industries.

Some of these include manufacturing, transportation, energy, healthcare, agriculture, financial services, and information technology. The organization is composed of experts in each of these markets and utilizes learnings from each industry to drive best-practices in others. 

One of the main objectives of standardization is usually that everybody adheres to the same standards, procedures, or product specifications. This may ease logistics, facilitate trade, prevent consumer deception, and improve quality. Plus, standardization assists with ensuring that the consumer always is left with the best possible products, and outcomes, from using these standards. 

How We Work With Regulatory Agencies

We are proud to work with and leverage direct contact with regulatory agencies (including ISO, the FDA, DEA, and State Pharmacy Boards), industry conferences (IACP, A4M World Congress, IMCAS and PCAA), and online research and exclusive partnerships. We are committed to constantly evolving our knowledge when it comes to sterilization, the pharmaceutical industry, and about compounding in general. We strive to always stay one step ahead of the game, and always keep up on the proper protocols provided by each organization, especially ISO. 

Additionally, we are firm believers in the ISO protocol related to terminal sterilization - that all products intended to be sterile should be sterilized within their final sealed container. This is something that we do through our Electron Beam Processing, which is recognized by ISO (ISO 13408-1). It truly is the future of sterilization processes!

Leave The Protocols & Compliance To Us

When working with us, we support your document control needs and preparation for regulatory audits. We are able to provide you with industry information and be an additional knowledge source base for compliance advice so that you can focus on what you do best. Leave the protocols and compliance to us. You can think of us as an extension of your quality control and quality assurance teams. It is our goal that you always feel confident in your sterile compounding operations, and that your products are as sterile as possible. 

With compounding pharmacy and outsourcing facility customers across the Americas, we have the benefit of engagement across the industry and the ability to cascade insights to our customers to keep them one step ahead in the compliance game. Working with us will mean that you’re always on the cusp of “what’s new,” and can be assured that we have done the research necessary for you. 

Working with MediZap for your sterilization needs shows your commitment to providing the highest quality products and services to your compounding patients. Contact us with any questions you have about compliance, or to learn more about our services. 

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