PharmaDirections is providing its formulation development expertise and InstantGMP is providing its electronic batch record format to publish master manufacturing formulas that can be used by dietary supplement manufacturers to make commercial scale batches.
PharmaDirections and InstantGMP have been tracking the difficulties that have befallen many dietary supplement companies who lack good master manufacturing formulas. Since the implementation of the Dietary Supplement Health and Education Act (DSHEA) dietary supplement producers must follow current Good Manufacturing Practices (cGMP) as defined by the FDA. The FDA is finding that more than 75 percent of all dietary supplement companies are not in compliance with cGMPs. PharmaDirections and InstantGMP decided to use their formulation development expertise and their electronic batch records systems to do something to help.
At least 25 percent of dietary supplement producers and packagers who are inspected by the FDA are receiving warning letters that could put them out of business if they don’t come into compliance. The majority of these letters describe deficiencies in master production records and batch production records or that the producers are not following a master manufacturing formula. Since PharmaDirections has significant expertise in formulation development and InstantGMP has software systems that make staying in compliance with cGMPs easy, they decided to collaborate in publicizing master manufacturing formulas for typical dietary supplement products. These are real master manufacturing formulas that can be produced for commercial supply.
The InstantGMP software provides the framework for master production records and batch production records that can help dietary supplement manufacturers keep in compliance with cGMPs. The master manufacturing records are available on the InstantGMP web site at their resource center. These include dietary supplement products such as Vitamin B complex, Vitamin C and calcium fortified with Vitamin D. Each master production record contains a bill of materials with a complete list of the ingredients and raw materials, and the list of equipment needed for manufacturing. The most important part is the detailed set of manufacturing instructions that describe how much material to weigh out in the proper order, how to blend, how to compress into tablets and how to coat the final product.