News & events

Therapeutic peptides are biosimilar molecules, composed of a-amino acid (AA) polymer with a defined sequence of not more than 40 AA covalently linked by amide bonds. These biosimilar molecules are crucial to various biological processes including hormone regulation, immune function, wound healing, and metabolisms.

USP 800 is a quality standard that promotes patient safety, worker safety, and environmental protection when handling hazardous drugs (HDs). It applies to all healthcare personnel who handle HDs, and all entities that store, prepare, transport, and administer HDs.

USP <797> sets minimum standards for compounded sterile preparations to prevent exposure to particulate matter that may cause patient harm. Particulate matter is the unwanted solid material in solutions for injection that can come from different sources. It's important pharmacies identify the source so they can implement preventive measures to manage particulate matter throughout the product lifecycle.

A Compounding Record (CR) is a document that records the preparation of a compounded medication. It is important to maintain compounding records to demonstrate compliance with USP standards.

A Master Formulation Record (MFR) is a detailed record of procedures that describes how the drug product is to be prepared. This documentation is an important component of regulatory compliance and effective process control.