Regulatory affairs (RA) in pharma is a critical function that ensures pharmaceutical products meet legal and safety standards before they reach the market. It involves compliance with national and international regulations governing drug development, approval, manufacturing, marketing, and post-market surveillance.…
Supply Chain Management (SCM) in pharma is the end-to-end control of materials, information, quality, and product flow from API/excipient suppliers to the patient—while maintaining GMP/GDP compliance, preventing counterfeits, and assuring continuous availability. The next layer is materials management and inventory…
Analytical Research & Development (Analytical R&D) in pharma is the function that develops, validates, and transfers test methods needed to characterize materials and ensure drug products meet quality requirements throughout development and commercialization. It bridges discovery, formulation/process development, manufacturing, QC,…
Pharmaceutical formulation and development involve transforming active pharmaceutical ingredients (API’s) into safe, effective, and patient-friendly medications. This process encompasses several key stages: 1. Pre-formulation Studies 2. Formulation Design 3. Process Development and Optimization 4. Quality by Design (QbD) 5. Regulatory…
Preventive Maintenance in Pharmaceutical Industry Preventive maintenance in pharma is a planned, systematic approach to maintaining equipment, utilities and facilities so they remain in a qualified, reliable and GMP-compliant state. Instead of waiting for failures to happen, activities are scheduled…
🚨 PRODUCT RECALL IN PHARMA A product recall is a critical GMP process used to remove a defective, potentially harmful, or non-compliant product from the market to protect patient health and comply with legal requirements. 🎯 1. Purpose of Product…
Microbiology SOP in Pharma plays important role in pharmaceuticals. Microbiology is the study of microscopic living organisms, such as bacteria and fungi. An applied subfield of microbiology is pharmaceutical microbiology. It entails the research of microorganisms related to the production…
Introduction: Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a vital role in ensuring the safety and efficacy of pharmaceutical products throughout their…
Corporate Quality Assurance SOP in pharma provides centralized oversight of quality systems, ensuring GMP compliance, standardized procedures, data integrity, and continuous improvement across all manufacturing and support units. In general, large companies with multiple sites have one site that serves…
By evaluating the tests for weight variation, hardness, and friability, for example, IPQA Instruments in Pharma assess the test results from in-process tests carried out in the production areas or laboratory for compliance with established sampling and testing protocols, analytical…
Manufacturing SOP in pharma, a component of the pharmaceutical business, is the process of synthesizing pharmaceutical medications on an industrial scale. A number of unit operations, including milling, granulation, coating, tablet pressing, and others, can be used to breakdown the…
Engineering SOP in Pharma is concentrated on planning, constructing, and enhancing pharmaceutical manufacturing facilities. Despite the fact that certain Pharma engineers also develop and formulate medications. The pharmaceutical industry’s stringent criteria for good manufacturing practise are one of the most…