Introduction: This User Requirement Specification (URS) defines the requirements for the selection, procurement, installation, qualification, and use of chemical instruments intended for [your organization/laboratory/production facility]. The purpose of this document is to establish a clear understanding between the end users,…
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,…
An “API Starting Material” is a raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. API Starting Materials normally…
Dry powder for oral suspension (often called dry syrup) is a solid mixture that is reconstituted with water before use. It is widely used for paediatric and geriatric patients who cannot swallow tablets or capsules and often contains antibiotics or…
Aerosols Qualification in Pharma: A Practical Overview Pharmaceutical aerosols are pressurised dosage forms that deliver a fine mist or spray from a container fitted with a valve system, such as inhalers and nasal sprays. Their qualification is critical because product…
In the world of Pharmaceuticals, a Factory Acceptance Test (FAT) is simply a series of test for a newly manufactured equipment. With a Factory Acceptance Test, you make sure that everything works properly before you deliver an Equipment to a customer. A…
The User Requirement Specification for Microbiology (URS) is offered to help the user with the crucial facets of fabrication, facilities for installing necessary equipment, cleaning and proper maintenance, cGMP, Safety, and regulatory requirements. The vendor is then given access to…
During Hold Time Study in Pharma, Good manufacturing practices (GMP) require that arrangements should be made to ensure that the dispensed raw materials and packaging materials, intermediate products, bulk, and finished products are stored under appropriate conditions. Storage arrangements should…
Temperature Mapping in Pharmaceuticals: Complete Guide What Is Temperature Mapping in Pharma? Temperature mapping (thermal mapping) is the study of temperature distribution within a temperature-controlled area such as warehouses, cold rooms, freezers, refrigerators, stability chambers and temperature-controlled vehicles. The goal…