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…
What is Risk Assessment? Quality Risk Assessment in pharma industry is a systematic process used to identify, analyze, and evaluate potential risks that may affect product quality, patient safety, or regulatory compliance. It forms the foundation of Quality Risk Management…
Process validation, according to the FDA, is “…the gathering and evaluation of data, from the stage of process design to commercial production, which establishes scientific evidence that a process is capable of reliably providing quality output.” The lifecycle idea is…
Every workplace has a specific set of hazards, and safety SOP in Pharma can help. The pharmaceutical manufacturing sector entails a variety of risks, including factory-specific concerns and drug hazards. Although maintaining health and safety can frequently be challenging, the…
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,…
Opthalmics Equipments Qualifications are crucial in the pharmaceutical industry. Ophthalmic Eye Drops: Uses, Formulation, and Bioavailability Challenges Ophthalmics (eye drops) are sterile liquid preparations designed for direct application to the surface of the eye, usually in very small volumes—typically one…
Dry Powder Injections Equipments Qualifications in pharma play a significant part in dry powder injection equipment. Dry powder injections are solid materials that are delivered in their final containers and which, when quickly derived from either transparent and essentially particle-free…
Oral liquids in Qualifications in Pharma are crucial. Pharmaceuticals include syrup, oral suspension, oral solution, oral drop, oral emulsion, mixture, linctus, and elixir among other oral liquid dosage forms. Oral liquids are homogenous liquid solutions that typically contain one or…