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Processes in pharmaceuticalmanufacturing such as processing, milling, grinding, and mixing, are associated with the generation of dust. The researchers highlighted that the risks of hazard exposure include danger to the health of operators and cross-contaminations during manufacturing.
The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceuticalmanufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. The post How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?
The practice of calling a piece of equipment clean just because it looks clean is not acceptable in the pharmaceuticalmanufacturing process. Why is cleaning validation required? Equipment that is used for processing medicines is one of the top sources of contamination if not cleaned effectively using a validated cleaning procedure.
Quality is everyone’s responsibility, and it should pervade every aspect of pharmaceuticalmanufacture and packaging. Quality should not be tested into products; instead, it must be built in at each step of manufacture. Pharmaceuticalmanufacturers must integrate the key functions of the quality control process.
TABLET FORMATS One of the problems with track and trace for pharmaceuticals across the world is the way drugs are dealt with on an item level in Europe and the US. In the US solid dosage forms are distributed as containers of tablets and these can only be coded on the container and not on a per-item basis.
Certain laboratory reagents are categorized as dangerous commodities, including but not limited to explosives and gases, combustible compounds, peroxides and oxidizing agents, infectious substances and poisons, radioactive materials, and corrosives. Reagents should only be used for the purposes for which they were designed.
Pharmaceuticalmanufacturing operations typically maintain equipment varying from simple balances and scales to complex automated process control and monitoring systems. – Gas Chromatography (GC) Systems (Critical for analyzing volatile compounds). When is equipment qualification necessary?
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