Discuss the various ICH guidelines for production and sale of herbal products.
Answers
A table is provided as an Annex of this document showing the link between each Q&A and the relevant Sections of ICH Q7 and other ICH Quality guidance. ... GMP principles as described in ICH Q7 should be applied regardless which approach is taken in pharmaceutical development and manufacturing.
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages,[1] cosmetics,[2] pharmaceutical products,[3] dietary supplements,[4] and medical devices.[5] These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user.[2] Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase.[2] GMP is typically ensured through the effective use of a quality management system (QMS).[1][2]