Post Views: 5,624 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…
Post Views: 5,577 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…
Post Views: 6,396 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…
Post Views: 6,257 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…
Post Views: 4,354 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…
Post Views: 6,151 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…
Post Views: 9,985 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…
Post Views: 2 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.…
Post Views: 10,189 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…
Post Views: 8,433 Microbiological Validations and Qualifications in Pharma Microbiological validations and qualifications in pharma ensure that manufacturing processes, cleanrooms, equipment, and testing methods consistently control microbial contamination. These activities are essential for GMP compliance, patient safety, and reliable product…
Post Views: 6,176 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…
Post Views: 46,173 STANDARD OPERATING PROCEDURE Nitrogen system qualification in pharma is the documented evidence that the nitrogen supply—whether from bulk liquid nitrogen (LIN) tanks, cylinder manifolds, or on-site nitrogen generators—consistently delivers nitrogen of the required quality to support GMP…
You can access this page after paying the subscription fees of 21 ₹ /month only.