Flair Pharma The Knowledge Kit.
Pharmaceuticals Industrial revolution
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
QMS in Pharma is a fundamental framework that organizations implement to ensure their products or services consistently meet or exceed customer expectations. It is a comprehensive set of processes, procedures, and policies meticulously designed to enhance efficiency, reduce errors, and bolster customer satisfaction. The implementation of a robust Quality Management System (QMS) is paramount. A … Read more
A pharmaceutical quality system is a set of processes, procedures, and practices that ensure pharmaceutical products are consistently manufactured to meet the required quality standards. The system includes a range of activities, such as product development, manufacturing, testing, and distribution. The primary goal of the system is to ensure patient safety by preventing product defects, … Read more
Failure Mode, Effects, and Criticality Analysis (FMECA) is used to identify potential failure modes in a system, process, or product, determine their potential impact, and prioritize corrective actions based on their criticality. FMECA is widely used in various industries, including pharmaceuticals, to improve product quality, reliability, and safety. It involves a systematic approach to analyzing … Read more
“Failure Mode and Effects Analysis (FMEA) is a proactive risk assessment tool that identifies and mitigates potential failures in products and processes. FMEA helps organizations prioritize risks, develop action plans, and continuously improve their processes to enhance product quality and reliability, comply with regulations, and enhance customer satisfaction.” Typical steps of the Failure Modes and … Read more
Container Closure Integrity Test (CCI) testing is an essential part of the aseptic filling process in pharmaceutical plants. CCIT ensures that the container and its closure maintain the intended barrier properties throughout the shelf life of the drug product, protecting it from contamination and degradation. Main Purpose of CCIT: The main purpose of CCI testing … Read more
Deviation in pharma refers to any departure from established standard operating procedures (SOPs) or specifications that could potentially impact the quality, safety, or efficacy of pharmaceutical products. Deviations can occur during any stage of the pharmaceutical product lifecycle, including manufacturing, testing, packaging, labeling, storage, distribution, or documentation. Deviation in Pharma Deviations in the pharma … Read more
Corrective Action and Preventive Action (CAPA) in the pharmaceutical industry, including their key steps, benefits, and importance in ensuring product quality, patient safety, and regulatory compliance. Understand how CAPA processes help identify and address root causes of quality issues, promote continuous improvement, and mitigate risks to enhance pharmaceutical operations. CAPA is an aid for improving … Read more
Chromatography in pharmaceuticals is a separation technique used to separate, identify, and quantify components of a mixture in order to ensure the quality, safety, and efficacy of pharmaceutical products. Chromatography involves the separation of a sample into its individual components based on their physicochemical properties using a stationary phase and a mobile phase. The stationary … Read more
21 CFR Part 11, also known as Title 21 Code of Federal Regulations Part 11, is a regulation issued by the U.S. Food and Drug Administration (FDA) that sets forth the requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries. It applies to pharmaceutical companies, contract research organizations (CROs), … Read more
Technology transfer in the pharmaceutical industry is a critical step in bringing a new drug or medical device from the laboratory to the market. It involves transferring knowledge, expertise, and technology from the research and development phase to manufacturing, quality control, and regulatory compliance. Technology transfer is essential to the process of discovering novel drugs … Read more