Current Good Manufacturing Practices or cGMP is the term used to describe a set of standards that govern the production of pharmaceutical products and medical devices. cGMP requires that each and every aspect of a production procedure be fully documented. Macrocyclics produces many of its products under cGMP's and is currently working to strengthen its capabilities in this area. Over the past year, the company has been developing the required Standard Operating Procedures that will be used to guide the cGMP production activities.
Current Good Manufacturing Practices or cGMP is the term used to describe a set of standards that govern the production of pharmaceutical products and medical devices. cGMP requires that each and every aspect of a production procedure be fully documented to ensure that the products are of the correct quality and that this quality can be readily reproduced. Macrocyclics already produces several of its products under cGMP's and is currently working to strengthen its capabilities in this area. Over the past year, the company has been developing the required Standard Operating Procedures (SOP's) that will be used to guide the cGMP activities.
The division of responsibilities for GMP production requires the establishment of a Quality Unit. This unit is the responsible for the testing and release of all materials within the GMP system. Macrocyclics will establish such a unit and this unit will function as required within the GMP system. The quality unit itself may be divided into a Quality Control function which conducts the testing and the Quality Assurance function, which oversees all procedures and is responsible for the release of all products.
As part of its GMP responsibilities, Macrocyclics is writing batch records for all production procedures and will ensure that these directions are followed as written. GMP production will allow Macrocyclics to participate further along the product development value chain as all materials used in clinical trials must be manufactured under GMP conditions. Our chelators are now used in several clinical trials and more are expected to be used in trials over the next several months.
In each country, one or more governmental organizations will usually regulate GMP activities within the pharmaceutical industry. In the United States, the Food and Drug Administration regulates the approval, manufacture and sale of all pharmaceuticals. They set guidelines under which pharmaceutical products must be manufactured and those guidelines are usually adopted as part of GMP's throughout the industry. FDA guidelines are intended to ensure that companies abide by Code of Federal Registry CFR21 Part 10, which is the Federal law that mandates the conditions under which pharmaceutical products must be produced. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is an international body that seeks to set common standards that are accepted across national boundaries. This council meets periodically to review requirements and update its recommendations.