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