Articles — compliance

Recently, the FDA has been providing much heavier guidance - and more Form 483s for objectionable conditions - with respect to the regulatory requirements of cGMP controlled raw materials. As a result, they are also providing more information on overall best practices for these materials. It is critical for those working in the pharmaceutical industry to understand the ever-changing requirements and best practices pertaining to cGMP. Regulations Guiding cGMP Controlled Raw Material are in FDA regulations 21 CFR 211.84 Subpart E: Testing and Approval or Rejection of Components, Drug Product Containers, and Closures Overview of the Regulation Section D of the FDA...

The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of pharmaceuticals, biologics, and much more. It is one of the leading regulatory and compliance agencies that a compounding pharmacy will work alongside while developing products. The FDA is responsible for routine inspections, which many manufacturers know all too well! But, three little numbers - 483 - can come from the inspections, and they mean serious business. But there are two different types of terms associated with these numbers: "Observations" and "Warning Letters." Today, we'll look at the difference between...

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...

Changes in the new USP 797 Regulations In 2022, revisions were published to the USP General Chapter 797 Pharmaceutical Compounding – Sterile Preparations, by the Compounding Expert Committee of the US Pharmacopeia Convention, on compounding nonsterile and sterile preparations, along with advanced standards for compounding radiopharmaceutical drugs. This is one of the first changes to the original regulation set of sterile compounding practice standards given by the United States Pharmacopeia (USP). The updates advocate for change in both structure and content, forcing processes to broaden and to increasingly become more effective. Below outlines the significant details that will most influence...