| To enable industries like the nutraceutical, medical | | | | compliance due to the sheer volume of technical |
| device, food and pharmaceutical industries to | | | | data and information processed during the |
| remain safe, GMP compliance is necessary for all | | | | manufacture of medical products. |
| companies to adhere. | | | | Keeping a detailed history of the manufacturing |
| GMP compliance consists of many guidelines which | | | | process is also absolutely essential to GMP |
| are designed to make sure that medical products | | | | compliance. This includes what is produced and |
| for patients and consumers are produced to the | | | | when, how the products that were manufactured |
| very highest of standards and specifications and | | | | have been distributed, where they have been |
| the basic principles of these are absolutely | | | | distributed to and for what purpose. This part of |
| imperative for the industry to follow and maintain. | | | | GMP compliance enables regulatory authorities to |
| A good starting principle for GMP compliance is for | | | | investigate when things go wrong using a proper |
| companies to make sure that they have defined | | | | trail of historical actions and clues and it helps |
| their manufacturing processes clearly and that | | | | businesses within the industry find problems and |
| controls are in place to regulate those processes. | | | | errors in their processes quickly and efficiently so |
| Consistent production is one way in which to | | | | that they can be rectified as a priority. Making |
| ensure that products are manufactured in a GMP | | | | sure that this process is adhered to is good |
| compliant way. Of course, part of the process of | | | | practice and will enable companies to stay at the |
| defining manufacturing processes would be to | | | | top of their game by beign able to improve things |
| include a procedure for change management, | | | | as they turn up. Businesses that do use GMP |
| recording and monitoring any impact that change | | | | compliance in the best way possible could get a |
| has on quality standards and then ensuring | | | | competitive advantage when used and |
| validation. | | | | implemented properly. |
| Good Manufacturing Practice also stipulates that in | | | | GMP compliance is important in many ways, but in |
| order to satisfy GMP compliance, all instructions | | | | the end, its instigation and use across the globe is |
| and procedural practices are recorded using | | | | to ensure that patients and consumers have a |
| unambiguous language and are written in such a | | | | high level of protection and safety from the |
| way as to provide absolute clarity, rather than | | | | products that are produced by pharmaceutical |
| absolute confusion. It could be considered as | | | | businesses, medical device companies and |
| perhaps one of the most difficult parts of GMP | | | | nutraceutical organisations. |