A Walk-In Stability Chamber is a large, temperature- and humidity-controlled environment used in pharmaceutical manufacturing to conduct stability studies on drug products, active pharmaceutical ingredients (APIs), and formulations. These chambers are crucial for evaluating how products behave under different environmental…
An Environment Monitoring System (EMS) in pharmaceuticals ensures that critical areas comply with the regulatory requirements for cleanliness, temperature, humidity, pressure, and microbial contamination. It is essential for maintaining product quality, ensuring patient safety, and meeting Good Manufacturing Practice (GMP)…
AHU Qualification in Pharma – Step-by-Step Guide AHU Qualification in Pharma are the heart of HVAC systems in pharmaceutical facilities. They control temperature, humidity, air cleanliness, and pressure differentials – all critical for maintaining classified area conditions as per GMP.…
A Hormone is defined as a chemical released by a cell or a gland in one part of the body that sends out messages that affect cells in other parts of the organism. Only a small amount of hormone is required…
Oncology in Pharma – Complete Overview Oncology is the branch of medicine that deals with the prevention, diagnosis and treatment of cancer. In pharmaceuticals, oncology is one of the most active and fast-growing therapeutic areas, with hundreds of new drugs,…
Lyophilizer Qualification in Pharma is an important aspect in pharma. Lyophilization, also known as freeze-drying, is a process used to preserve a perishable material or make it more convenient for transport. It works by freezing the material and then reducing…
Facility qualification in pharma is a systematic process of verifying and documenting that the design, construction, and operation of a pharmaceutical facility meet GMP requirements and ensure product quality and patient safety. 1. Purpose of Facility Qualification 2. Phases of…
A walk-in stability chamber is a controlled environment designed to simulate specific conditions such as temperature, humidity, and light to test the stability and shelf life of products. These chambers are commonly used in industries like pharmaceuticals, biotechnology, and food…
🧪 Qualification of IPQC Instruments in Pharma ✅ What are IPQC Instruments? IPQC (In-Process Quality Control) instruments are devices used during manufacturing to monitor and control product quality in real time.Examples: Because they directly impact product quality decisions, their qualification…
A Practical Overview Stability studies in pharma are designed to show how the quality of a drug substance or product changes over time under the influence of temperature, humidity and light. The data are used to set shelf-life, re-test period…
All criticalities that emerged during the FAT exercise are then checked again at the final site, after installation and verification; additional test cases may also be added to the Site Acceptance Test (SAT) protocol to check for potential failure modes. SAT testing…
Microbiology Instruments Qualification plays important role in pharmaceuticals. Microbiology equipment is a large category covering all kinds of items used in microbiology laboratories. Microbiology is the study of microscopic life forms and is used by scientists studying viruses, plants, fungi,…