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…
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 quality—especially for sterile…
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…
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 manufacturing. Nitrogen is…
Compressed air Qualification in pharma is proof that certain factors, including aerosol particle content, dew point, liquid water concentration, vapour content, oil aerosols, and other contaminants, are below acceptable limits and do not contaminate the product. In order to deliver…
STANDARD OPERATING PROCEDURES OF WATER SYSTEM Water System Qualification in pharma is a core GMP activity that proves the Purified Water (PW) or Water for Injection (WFI) system consistently produces water that meets its intended quality for manufacturing, cleaning, and…
The User Requirements Specification (URS) is offered to help the user navigate the crucial aspects of fabrication, facility for installation of required equipment, cleaning and proper maintenance, cGMP, safety, and regulatory requirements necessary to build and fabricate a functional equipment…