| Good manufacturing practice or (GMP) is a common | | | | carry out a specific procedure, is adequately trained |
| term for the control, management and manufacturing | | | | for that procedure to the exact specification |
| of quality control practices, applied to the | | | | determined in the validation process. GMP regulations |
| pharmaceutical industry. These common practice | | | | also helps to ensure product safety by properly |
| standards are specifically designed for pharmaceutical | | | | investigating any complaints about medicines or other |
| substances and products being made for clinical trials | | | | drugs, as well as taking the correct safety measures |
| and production. And one recent area of cGMP | | | | in new fields of study. And one of these fields is |
| concern is over the newly emerging stem cell | | | | stem cell research. |
| research industry. How will stem cell research be | | | | Because of the continually evolving cGMP regulations, |
| affected by these ever tightening restrictions, and will | | | | the assurance of quality control compliance in the |
| they really help to bring compliance to stem cell | | | | stem cell industry is not as cut and dried as you |
| product manufacturing? | | | | might think. Because stem cell research is a new and |
| Many of the world's largest manufacturers in the | | | | untapped field of medicine, current cGMP regulations |
| pharmaceutical and medical product industry are | | | | may require some adaptation. for this advanced |
| legislated under the jurisdiction of cGMP guidelines. | | | | medicine, This makes it harder for pharmaceutical |
| The details of these guidelines vary from country to | | | | companies to effectively develop their manufacturing |
| country, although each country follows the same | | | | processes. |
| basic principles. GMP compliance is important because | | | | However, due to the attention this promising area of |
| it assures the quality of medical products by | | | | science is receiving, many non-profit organizations and |
| governing and setting guidelines and restrictions over | | | | pharmaceutical experts & Life Science consultant |
| every stage in the manufacturing process. This is | | | | experts are focusing their attention on these issues |
| conducted by following a series of established | | | | to develop suitable solutions. |
| regulations which outline manufacturing practices & | | | | This important research is directed towards acquiring |
| how they should be monitored. | | | | the basic knowledge necessary in the understanding |
| GMP compliance guidelines & regulations help to | | | | of stem cells and how to effectively turn the science |
| assure that all manufacturing processes are clearly | | | | into effective medicine. This study is focused on the |
| definedand well-controlled. It assures that all critical | | | | development of creating new stem cell therapies that |
| stages of manufacturing and development are | | | | will not only fit all cGMP regulations, but will be |
| validated to guarantee compliance and consistency | | | | successful therapies in treating real human diseases. It |
| within cGMP regulations. It also helps to ensure that | | | | is only a matter of time before enough research is |
| all instructions associated with every stage are clearly | | | | conducted, so that stem cell therapy can become an |
| defined, and carried out in the right manner. It also | | | | integral part of today's main stream medicine & the |
| helps to guarantee that every operator trained to | | | | pharmaceutical manufacturing industry. |