Government authorities regulate the pharmaceutical industry to ensure that no drugs enter the market which are unsafe. The regulations are constantly adapting as more and more products are launched onto the market so pharmaceutical companies need to stay up to date, they do this through continued training. There are two main areas that companies should focus on which will keep them in line with the regulatory authorities. These are Regulatory Compliance Training and Validation Training.
It is necessary that a company’s practices are in line with the regulations because the regulating bodies are legally entitled to carry out unannounced inspections wherever they see fit.
To make sure that pharmaceutical regulations are similar across the regions of Europe, Japan and the US, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was set up with members of the regulatory authorities and industry experts.
There are minimum requirements that have to be met during the manufacturing and packaging stages of drug production which are governed by through pharmaceutical regulatory compliance. Human safety is the main focus of these regulations which also check to make sure the ingredients listed and the stated strength are correct. Quality assurance and the marketing of products also come under the field of compliance. It is therefore essential to maintain pharmaceutical training so that the drugs a company manufactures are safe and of good quality.
As well as compliance, pharmaceutical training is also important in validation, the process of establishing documented evidence that a process will have the same outcome every time it is performed. Validation prevents rogue batches of drugs and mistakes in ingredients and strengths among other factors. Some aspects of validation include cleaning, protocols and computer system validation.
So you see, it is important to keep up to date with your company’s pharmaceutical training so you do not break any regulations or laws which govern the industry.