| In the UK and European Union, companies who | | | | carry out GMP training to make sure they are up to |
| manufacture and distribute medicinal products are | | | | date with all the processes involved in the collection, |
| required by law to hold the appropriate license. They | | | | transportation, testing, storage and delivery of |
| are also subject to the regulations of the Good | | | | collected blood samples. This is to make sure that |
| Manufacturing Practice and Good Distribution Practice | | | | every blood transfusion which takes place is using |
| requirements that are in place to protect the general | | | | quality blood free from harmful factors such as |
| health of the public and the qualified personnel | | | | transmittable diseases. |
| involved in the manufacturing and distribution | | | | GMP practices surrounding blood are different from |
| processes. The 'Rules and Guidance for | | | | those covering the production and distribution of |
| Pharmaceutical Manufacturers and Distributors', | | | | medicines. In the latter case, the doctor and |
| otherwise known as the 'Orange Guide' is published | | | | pharmacist who prescribe the medicine have no way |
| to help companies and individual personnel comply | | | | of knowing the quality of the product, so they rely |
| with GMP regulations that govern the international | | | | on the manufacturer to produce products which are |
| pharmaceutical industry. | | | | safe for human use and comply with GMP regulations. |
| The 'Orange Guide' was first published in 1971 and | | | | With blood, the National Blood Service should be |
| since then it has become the premier guide for | | | | looked at as the manufacturer and the blood bank is |
| everyone involved in the production of medical | | | | the pharmacist. The blood bank has to trust the NBS |
| products, regularly republished with amendments as | | | | that it has tested the blood and it is safe to be used |
| regulations and requirements evolve. The guide is | | | | on their patients. |
| used across the EU and is one of the most | | | | The 'Orange Guide' is necessary reading for any |
| comprehensive, convenient and authoritative | | | | qualified person who is involved in the manufacture or |
| publications on the UK and EU regulations governing | | | | distribution of medicines, drugs or blood. Whilst their |
| the production and distribution of medical products. It | | | | company should ensure that they are kept up to |
| collates all the relevant documents and legislation | | | | date with the regulations and laws governing the UK |
| concerning the industry as well as any new initiatives, | | | | and EU pharmaceutical industry by providing them |
| directives or laws which have come into action since | | | | with regular GMP training. Pharmaceutical consulting |
| its previous publication. For example, the 2007 | | | | firms are good if you do not have the expertise to |
| addition detailed the changes to EU GMPs and the | | | | carry out this training yourself. Hey make it their job |
| revised code of practice for qualified persons. | | | | to stay up to date with all the relevant regulations |
| Not only do GMP regulations cover drugs and | | | | and laws governing the industry which is often too |
| medicines intended for human use but also blood, | | | | great a demand on the workloads of manufacturing |
| which is collected with the purpose of being used in a | | | | businesses. |
| patient. Staff at the National Blood Service need to | | | | |