Qualified Persons As Per European Pharmaceutical Regulations
Under European Union (EU) law, the qualified person (QP) is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a…
Under European Union (EU) law, the qualified person (QP) is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a…
Depyrogenation devices, such as tunnels, are used in the pharmaceutical industry to prepare components for aseptic filling. To qualify such devices, various pharmacopoeias require depyrogenation…
Stability study is a vital stake of the drug development process. Stability is the only way that assures whether the drug is within acceptance criteria…
Drug evolution process is a novel concept proposed to develop chemical libraries that have a high probability of finding drugs or drug candidates. It converts…
Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world.…
The disintegration test is used to show how quickly the tablet breaks down into smaller particles, allowing for a greater surface area and availability of…
Validation of HVAC System includes compiling documents of design, drawing of the design and its plan, Master plan of the validation process, TAB – testing,…
ALCOA is key to Good Documentation Practice (GDP). ALCOA relates to data, whether paper or electronic, and is defined by USFDA guidance as Attributable, Legible,…
In this course learn how the sampling of material is done & the complete process of how it is released. What will you learn Process…
WHO guidelines are primarily intended for use by governmental organizations, such as drug regulatory authorities (including inspectorates), quality control laboratories and customs and police officials,…
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