All personnel who compound or have direct oversight of compounding sterile and/or non-sterile (CSPs & CNSPs) must be initially trained and qualified by demonstrating knowledge and competency according to the requirements before being allowed to perform their job functions independently. Designated person(s) are responsible for creating and implementing a training program that describes the…
A master formulation record (MFR) is a detailed record of procedures that describes how the CNSP or CSP is to be prepared. An MFR must be created for each unique formulation of a CNSP or CSP. CNSPs or CSPs are to be prepared according to the MFR, and the details of each preparation are to…
All facilities where compounded nonsterile preparations (CNSPs) are prepared must have and maintain written or electronic documentation to demonstrate compliance with the requirements. This documentation must include, but is not limited to, the following: All facilities where compounded sterile preparations (CSPs) are prepared must have and maintain written or electronic documentation to demonstrate compliance…
Excipients are typically the major components of a solid dosage form and are included for a number of reasons such as to aid the manufacturing process and stability or to add functionality to the formulation. Diluents Binders and Adhesives Disintegrants Lubricants Glidants Coating Agent Colors, flavors, and sweeteners…
Parenteral administration a. Intravenous bolus injection: The drug is injected directly into the bloodstream, distributes throughout the body, and acts rapidly. Any side effects, including an intense pharmacologic response, anaphylaxis, or overt toxicity, also occur rapidly. b. Intra-arterial injection: The drug is injected into a specific artery to achieve a high drug concentration in a…
Hydrophilic–lipophilic balance (HLB) is a way of measuring solubility based on the hydrophilic and lipophilic moieties of a surfactant molecule. HLB Value Range and Surfactant Application Commonly Used Surfactant and Their Hydrophilic-Lipophilic Balance (HLB) Value Read also: