The pharmaceutical industry is heavily regulated by government and independent authorities to ensure that drugs coming onto the market are safe for humans to use. Pharmaceutical companies stay up to date with the ever adapting regulations through employee training and development. There are two main areas that companies should focus on which will keep them in line with the regulatory authorities. Validation training and regulatory compliance 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.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was set up as a partnership between Europe, Japan and the US so that the regulatory authorities can work together and strive for the same standards.

The methods, facilities and controls applied in the manufacturing, processing and packaging of drugs entering the market are all controlled through pharmaceutical regulatory compliance. These steps ensure that the drug is safe for humans to use and that the ingredients and strengths detailed on the package are what the drug actually contains. Quality assurance and the marketing of products also come under the field of compliance. To ensure that their products are safe and meet the minimum quality regulations, pharmaceutical training is necessary.

It is also necessary to continue pharmaceutical training in the field of validation, which establishes documented evidence that certain processes will have the same outcome every time. 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.

To make sure that you remain in line with the regulations and laws governing the production of drugs and the entire industry, it is vital to carry out continuous pharmaceutical training.