cGMP Guidelines/Regulations in Stem Cell Research
Good manufacturing practice or (GMP) is a common term for the control, management and manufacturing of quality control practices, applied to the pharmaceutical industry. These common practice standards are specifically designed for pharmaceutical substances and products being made for clinical trials and production. And one recent area of cGMP concern is over the newly emerging stem cell research industry. How will stem cell research be affected by these ever tightening restrictions, and will they really help to bring compliance to stem cell product manufacturing?
Many of the world’s largest manufacturers in the pharmaceutical and medical product industry are legislated under the jurisdiction of cGMP guidelines. The details of these guidelines vary from country to country, although each country follows the same basic principles. GMP compliance is important because it assures the quality of medical products by governing and setting guidelines and restrictions over every stage in the manufacturing process. This is conducted by following a series of established regulations which outline manufacturing practices & how they should be monitored.
GMP compliance guidelines & regulations help to assure that all manufacturing processes are clearly definedand well-controlled. It assures that all critical stages of manufacturing and development are validated to guarantee compliance and consistency within cGMP regulations. It also helps to ensure that all instructions associated with every stage are clearly defined, and carried out in the right manner. It also helps to guarantee that every operator trained to carry out a specific procedure, is adequately trained for that procedure to the exact specification determined in the validation process. GMP regulations also helps to ensure product safety by properly investigating any complaints about medicines or other drugs, as well as taking the correct safety measures in new fields of study. And one of these fields is stem cell research.
Because of the continually evolving cGMP regulations, the assurance of quality control compliance in the stem cell industry is not as cut and dried as you might think. Because stem cell research is a new and untapped field of medicine, current cGMP regulations may require some adaptation. for this advanced medicine, This makes it harder for pharmaceutical companies to effectively develop their manufacturing processes.
However, due to the attention this promising area of science is receiving, many non-profit organizations and pharmaceutical experts & Life Science consultant experts are focusing their attention on these issues to develop suitable solutions.
This important research is directed towards acquiring the basic knowledge necessary in the understanding of stem cells and how to effectively turn the science into effective medicine. This study is focused on the development of creating new stem cell therapies that will not only fit all cGMP regulations, but will be successful therapies in treating real human diseases. It is only a matter of time before enough research is conducted, so that stem cell therapy can become an integral part of today’s main stream medicine & the pharmaceutical manufacturing industry.
Nigel Smart is a pharmaceutical consultant (smartconsultinggroup.com/pharmaceutical-consultants.html)
Last edited by Oleks; Mar 30, 10 at 17:34.