Preparation of Master Formula Record (MFR)
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
Design Qualification (DQ)in Pharma
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) In Pharmaceuticals
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
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
