Validation is defined as per various bodies EC, ICH, FDA, WHO as given below: According to European Commission 1991: Validation-“Act of proving, in accordance of GMPs that Any…” process actually leads to expected results. 2000: “Documented evidence that the process, operated within established ...

“OOT” stands for Out Of Trend. It means any test results obtained for a particular batch that is markedly different the results of the batches in a series obtained using a same validated method.

Monitoring the manufacturing process at different stages is called in-process control. In-process control of the process provides an acceptable and achievable level of built in quality assurance for the product. This is possible through appropriate GMP during all manufacturing steps. Or Checks performed ...

A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. Or A process condition or material or a test when it is essential to maintain a predetermined rage in order to reproducibly ...

A condition or set of conditions encompassing upper and lower processing limit and circumstances, within standard operating procedures, which poses the greatest chance of product or process failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure.

It is periodic inspection and minor repairs of equipment as per schedule given in the SOP. This enables smooth operation and long life of the equipment. It also avoids major breakdown of the equipment during manufacturing of the product. There are two types of maintenance. Preventive maintenance: Schedule ...

The process of identifying, assessing, and correcting deviations from approved instructions or established standards is known as deviation management. Let us consider the pharmaceutical industry as an example. Your cleanroom’s high-efficiency particulate air filters have failed, potentially contaminating ...

Clinical trials are prospective biomedical or behavioral studies on human participants designed to answer specific questions about new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that further confirm the biomedical or behavioral ...

Petrolatum is also known as yellow soft paraffi n. It is an inert material obtained from petroleum, which contains branched and unbranched hydrocarbons. It is available as soft oily material and appears pale yellow to yellow in color. Various grades of petrolatum are commercially available with varying ...

Dry Powder for Suspension: Dry powder for suspension are preparations of finely powdered drug intended for suspension in liquid vehicles. They are generally reconstituted with recommended volume of purified water. A dry mixer of an Antibiotic e.g. Ampicillin, whenmixed with one or more suitable buffers, ...