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…
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…
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…
Utility in Pharma like WFI, RODI, Compressed Air, Nitrogen, Air Handling Units (AHU) and HVAC (Heating, Ventilation and Air Conditioning) systems support the manufacturing process. Quantitative and qualitative requirements: In order to be deemed satisfactory, utility in pharma must meet…
Large volume parenteral equipments qualifications in pharma play a significant role. Injectable aqueous medication products that have been terminally sterilized (autoclaved) and packed in single dose containers typically have a capacity of 100 ml or more are known as large…
Form Fill Seal Equipments qualifications in Pharma are crucial. To prepare sterile items, form fill seal (FFS) technology uses automated computer control. A producer needs up-to-date, dependable packaging equipment in order to make better packages more rapidly and profitably. Form-fill-seal…
Ampoule equipment qualification in pharma is the documented proof that every machine used to manufacture, wash, depyrogenate, fill, seal, and inspect ampoules consistently works as intended and meets GMP requirements. A robust qualification program reduces contamination risk, prevents batch failures,…