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Quality Assurance (QA) in the Pharmaceutical industry, is very essential for ensuring that Pharmaceutical Products are manufactured to a safe and consistent standard, and references with the guidelines e.g. WHO good manufacturing practices: main principles for pharmaceutical products.

 

Quality management in the drug industry: philosophy and essential elements (update on sampling), Heating Ventilation, and air-conditioning systems for non-sterile pharmaceutical dosage forms.Validation, Water for pharmaceutical use.

WHO good manufacturing practices: starting materials, Active pharmaceutical ingredients (bulk drug substances). Pharmaceutical excipients.

WHO good manufacturing practices: specific pharmaceutical products, Sterile pharmaceutical products, Biological products, Investigational pharmaceutical products for clinical trials in humans, The manufacture of herbal medicines, Radiopharmaceutical products. 

Inspection: Pre-approval inspections Inspection of pharmaceutical manufacturers, Inspection of drug distribution channels. Quality systems requirements for national good manufacturing practice inspectorates. Guidance on good manufacturing practices: an inspection report, Model certificate of good manufacturing practices, etc.

Hazard and risk analysis in pharmaceutical products, Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals. Sampling operations, Sampling of pharmaceutical products, and related materials.

Since QA is such a broad field, it can be helpful to look at specific ways that it is implemented in practice. Here’s a look at a few concrete examples of how QA works in real life so you can get a better idea of why it is so important in the pharmaceutical industry.