Posts by Natasha Gayle
Your Guide to Pharmaceutical Validation & 6 Principles for Effective Implementation
In good manufacturing practice (GMP) and other GxP’s, the term validation has a formal, specific meaning. In this context, validation is a quality management tool used to confirm that a process or a piece of equipment satisfies its intended purpose through the use of objective data. In highly regulated industries like pharmaceuticals, validation is used…
Read MoreWhy Is Temperature Mapping in Pharma Important?
A growing trend in the pharmaceutical industry is the development of more complex and fragile products, like biologicals, chemical mixtures, and large molecules (COVID-19 vaccines are an example of this trend). These products generally must follow a standard operating procedure (SOP) that requires more stringent temperature controls to prevent them from degrading or deactivating during…
Read More8 Remote Patient Monitoring Tools Hospitals & Providers Can Use to Improve
At Dickson Data, we develop precise and consistent temperature and humidity monitoring solutions to comply with ever-changing health and safety regulations in the heatlhcare industry, which makes us naturally curious about other monitoring, sensing, and data collection tools being used Hospitals use our temperature data loggers throughout their facility to keep track of vaccine temperatures,…
Read MoreCreating a HACCP Food Safety Plan: What Your Organization Needs to Meet Food Safety Compliance Standards
Food safety is an underlying concern touching every corner of the food industry, from manufacturers and distributors to the consumers ultimately eating the food. Hazard Analysis and Critical Control Points (or HACCP) is an internationally-recognized method of identifying and managing the risks related to food safety, designed to keep the food in question safe from…
Read MoreUnderstanding Pharmacy Temperature Requirements for Medication Storage
If vaccine and pharmacy medication storage reaches the wrong temperature, several things can happen – rendering them less effective than intended or even chemically altered, causing inadvertent patient harm. Because of this risk, strict pharmacy temperature requirements have been put into place to ensure medications are manufactured, transported, and stored properly before they reach the…
Read MoreWhat Is IQ OQ PQ? How to Navigate Essential Quality Assurance Processes in Manufacturing
According to the FDA, “the term qualification refers to activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly. These activities necessarily precede manufacturing products at the commercial scale.” Qualification can be further broken down into three phases: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ),…
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