Definitions As Per CGMP
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing…
Tag: Paid QA Course
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…
Qualification of Tunnel Sterilizing Machine
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 Studies In Drug Development Process
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…
IND, NDA & ANDA Drug Evolution Process
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…
Drug Regulatory Affairs And Its Common Terminologies
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.…
Disintegration Test for Tablets And Capsules
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…
HVAC System Validation Tests
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 In Pharmaceutical Industry
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,…
Sampling and Release of Material
In this course learn how the sampling of material is done & the complete process of how it is released. What will you learn Process…
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