Good Manufacturing Practice (GMP) Regulations monitor the industries under the Food, Drug and Cosmetic Act all of which can have an impact on human safety and thus need regulating, including the pharmaceutical and biotechnical industries. It is therefore essential that your organization stays up to date with GMP training as new regulations are issued and you manufacture new products. In the US, Good Manufacturing Practices are managed by the Food and Drug Administration (FDA), which is itself an agency of the Department of Health and Human services and in Europe they are subject to European authorities. As such, the regulations and laws of the FDA and its bodies can have legal ramifications if not adhered to, with known criminal cases against businesses and individual employees who have failed to comply with GMP regulations.
In order for your company to comply with GMP regulations, every employee needs to know their responsibilities to ensure that the manufacture process is clean, effective and validated. This reduces the likelihood of contamination and errors, which can put consumers lives at risk. It is a legal requirement 먹튀검증 that every member of staff is regularly trained in GMP, so that they can carry out personal self assessment audits on their work processes. GMP regulations cover every area of drug manufacture including cleanliness, sanitation, process validation, equipment verification, complaint handling and record keeping. If regulations are met in every aspect of the production process, a company’s standards of practice should be high and they will consistently produce good quality, safe drugs. But they will only be able to comply with any of these areas if GMP training is carried out on a regular basis.
GMP training can take many forms, from large group lectures given by FDA or EU consultants to smaller demonstration and task based methods. Whilst lectures have shown to have some advantages, continuous, long lectures can have a negative affect as participants become bored and switch off. Demonstrations that involve participation on the side of employees are successful in engaging participants and embedding the information and skills that they learn deep into their knowledge base. They can then take this back to the work place with them, along with any supporting written material that accompanies their training.
Training is an essential part to every step during production. There are strict regulations governing research, trials, manufacture, packaging, distributing and marketing new pharmaceutical drugs so GMP training is necessary at every level. If your company has a presence in both the US and Europe it is important that staff are trained on both FDA and EU Good Manufacturing Practice regulations, as there are significant differences in their regulations as well as important similarities. What may be lawful in Silicon Valley may not be so in parts of Europe.