Flair Pharma The Knowledge Kit.
Pharmaceuticals Industrial revolution
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
The Annual Product Quality Review (APQR) stands as a cornerstone in the realm of pharmaceuticals, ensuring the maintenance of high-quality standards. APQR is a comprehensive evaluation conducted annually to assess the quality of pharmaceutical products. It serves as a regulatory requirement in many countries and plays a vital role in maintaining product integrity, patient safety, … Read more
The realm of pharmaceuticals encompasses a diverse landscape where market complaints hold significant importance. Effectively addressing these complaints requires a nuanced understanding of perplexity and burstiness, two crucial factors that shape the discourse within this industry. Perplexity serves as a yardstick to measure the intricacy of textual content. In the context of market complaints in … Read more
Incidents in the pharmaceutical industry refer to unexpected events or occurrences that disrupt normal operations and have implications for patient safety, regulatory compliance, or ethical standards. These incidents can encompass a wide range of situations, such as product recalls, adverse drug reactions, manufacturing issues, regulatory violations, data breaches, ethical misconduct, and supply chain disruptions. When … Read more
Risk Assessment in the pharmaceutical industry begins with the identification and evaluation of potential risks at various stages, including research and development, manufacturing, distribution, and post-marketing surveillance. These risks can encompass a wide range of factors, such as product quality issues, adverse events, regulatory non-compliance, supply chain vulnerabilities, and emerging safety concerns. Through meticulous analysis … Read more
Quality assurance is a crucial aspect of pharmaceutical manufacturing to ensure that products meet the required standards of safety, efficacy, and quality. It involves a range of activities and processes aimed at maintaining and improving product quality throughout the entire manufacturing process. Here are some key aspects of quality assurance in a pharmaceutical plant: Quality … Read more
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