Flair Pharma The Knowledge Kit.
Pharmaceuticals Industrial revolution
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
The Master Formula Record (MFR) is the backbone of pharmaceutical manufacturing. It dictates “what to make, how to make it, and what standards to meet.” Crafting an MFR is not merely a documentation exercise; it’s an orchestration of science, compliance, and process integrity. Below is a uniquely structured representation of how an MFR is prepared … Read more
Definition: Design Qualification (DQ) is a documented verification process that ensures the proposed design of facilities, systems, or equipment is suitable for the intended purpose, meets all user requirements, and complies with regulatory expectations (e.g., cGMP, FDA, EU-GMP, ISO). DQ confirms that the design outputs (drawings, layouts, specifications) align with the defined user and quality … Read more
Operational Qualification (OQ) is the documented verification that a system or equipment performs as intended across all specified operating ranges. It is the second phase in the validation sequence: Installation Qualification (IQ) → Operational Qualification (OQ) → Performance Qualification (PQ) If IQ is the blueprint check, OQ is the machinery rehearsal—ensuring every part does what … Read more
Classifications of Bacteria, the microscopic, single-celled organisms, are among the most ancient and ubiquitous life forms on Earth. Despite their diminutive size, bacteria play a crucial role in ecosystems, human health, industry, and even space exploration. They exhibit remarkable diversity in structure, metabolism, and habitat adaptability, ranging from the human gut to deep-sea hydrothermal vents … Read more
Quality slogans for a Pharmaceutical Formulation Manufacturing Facility
Starting a pharmaceutical company is an ambitious and rewarding venture. It involves a blend of strategic planning, regulatory compliance, financial investment, and a vision to improve healthcare. Whether you aim to manufacture medications, develop innovative drugs, or distribute pharmaceutical products, this guide will walk you through the process of establishing your own pharmaceutical business. 1. … Read more
A Validation Master Plan (VMP) is a cornerstone document in pharmaceutical and manufacturing industries, providing a structured approach to validation activities. Its importance lies in ensuring that systems, equipment, and processes meet regulatory requirements and function as intended. This guide outlines the key steps to create a robust VMP, incorporating principles, strategies, and best practices … Read more
The modern pharmaceutical industry requires state-of-the-art facilities to meet strict regulations, ensure product quality, and optimize operational efficiency. Designing a modern pharmaceutical facility involves considering aspects like compliance with regulatory standards, flexibility, cost efficiency, and advanced technology integration. This article explores the critical components, challenges, and best practices for designing cutting-edge pharmaceutical facilities. 1. Regulatory … Read more
