GMPs in the Raw (Materials)

LAS VEGASGMP (good manufacturing practices) start with proper raw material documentation, but FDA 483 forms and warning letters show many supplement companies don't properly address this crucial step. Representatives from Herbalife Ltd. and Joys Quality Management Systems shared tips on documenting raw materials to ensure GMPs are followed at SupplySide West 2012.

Joy A. Joseph, president, Joys Quality Management Systems, said the regulation is clear that raw materials (both components and dietary ingredients) need to be tested for identity, specifications and contamination. And these tests need to be documented. Joseph added that quality control (QC) reps need to approve or reject raw materials and the test procedures.

Further, Joseph explained that supplement manufacturers need to verify vendors raw materials specifications and certificates of analysis (CoAs), and they need to document that they tested it. CoAs must include a description of the tests completed as well as the actual results.

Monica Ito, document control manager, Herbalife Ltd., noted what makes a good spec sheet (supplier letterhead, raw material name and test parameters) and what makes a good COA (lot/batch  number, manufacturing date, signature and date).  A spec sheet communicates the specifications of a raw material and defines the requirements that must be satisfied. A CoA is an authenticate document that certifies the quality and compliance of a raw material, assuring the material meets specs before it's added to the product.

Composition statements are also important, Ito said, because they describe what is in the material and dictates which additional regulatory documents are needed. A good composition statement lists the raw material name, subcomponents (including excipients, preservatives, etc.) and gives the quantitative amount (or range) of each subcomponent.

Donna Webster, Ph.D., manager of scientific affairs and outer nutrition, global product science and safety, Herbalife Ltd., outlined the steps that a manufacturer should have in a raw material manufacturing flowchart. A manufacturing flowchart shows the basic steps of transforming starting materials into a finished raw material. This flowchart should have the name of the starting material (such as a latin binomial) and explain the manufacturing method (extraction method, grinding, drying, filtration, etc.) and include any excipients that are added along the way.

See the entire presentation, "Raw Material Documentation and GMP Compliance," by purchasing the SupplySide West 2012 Natural Products INSIDER Premium Education Package DVD in the SupplySide Store.