This course is designed for learning/ understanding on Basic Good Manufacturing Practices (GMP) applicable for all Pharmaceutical professionals. GMP applies from product development till product delivered to the end user. There are multiple different activities involved e.g. Product development, technology transfer, material management, facility and equipment, production, analysis and dispatch. The GMP is mandatory to follow at each stage to ensure a consistent product quality each time and all the time.
The course will start with a basic understanding on role of Pharmaceutical Industry, different functions/ departments, educational qualification required to work in different section of pharma industry along with current challenges. The next chapter will be the Regulations and Acts applicable to Pharma Industry related to GMP. The following chapters will be in a sequential manner from Organisation and personnel then Premises and Equipment required for producing the pharma product, Material management includes from vendor qualification to material dispensing, Product and process control followed by Quality control for analysis of material and product. The over and above, Pharmaceutical Quality System has been included to understand the management responsibility, quality manual, elements of GMP and brief on quality system requirement from product development to discontinuation.
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