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It would be acceptable to consider that raw materials used to manufacture pharmaceutical products can vary in their attributes e.g. moisture content, crystal structure etc. It would also be acceptable to consider that manufacturing equipment does not always operate in exactly the same fashion due to the inherent tolerance of the equipment and ...
Pharmaceutical Laboratory: fully equipped for students to perform tests on pharmaceutical raw material, in-process material and finished products. Analytical Chemistry Laboratory: includes sample preparation station, wet chemistry testing station, physical chemistry testing station, HPLC, UV, IR, Autotitrators, pH meters.
The National Institute for Pharmaceutical Research and Development (NIPRD) is a Nigerian institution charged with developing drugs, biological products, and pharmaceutical raw materials, conducting quality-assurance tests, research for locally manufactured medicines and constituting guidelines for their production.
An assay (analysis) is never an isolated process, as it must be accompanied with pre- and post-analytic procedures. Both the communication order (the request to perform an assay plus related information) and the handling of the specimen itself (the collecting, documenting, transporting, and processing done before beginning the assay) are pre-analytic steps.
This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.
Quality Control (Testing) Laboratory: an analytical testing laboratory equipped with modern high performance liquid chromatography (HPLC) with advanced computer integration software, mass spectrometer (MS), ultraviolet-visible (UV-VIS) spectrophotometers, raw material and finished product testing equipment such as dosage form dissolution ...
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