Flair Pharma The Knowledge Kit.
Pharmaceuticals Industrial revolution
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
“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
There are Different sources of Contamination in Aseptic Area. An aseptic area is a premise in a clean area, designed, constructed, serviced, and used with the intention of preventing microbial contamination of the product. It is essential to identify the sources from which the contaminants can enter the aseptic area in order to avoid the … Read more
Quality Control in the pharmaceutical industry has a crucial role in the quality slandered of Pharma products. The main goal of quality control is to evaluate and compare product quality to predefined criteria. Quality control is therefore the most important aspect of the pharmaceutical industry. The process of quality control also includes finding any product … Read more
Validation in pharma industrial plants is a process of creating official documentation proving that a procedure, process, or activity used in testing and ultimately manufacturing maintains the appropriate degree of compliance at all times is known as validation in the pharmaceutical industry. In the pharmaceutical sector, it is crucial to guarantee that the process will … Read more