ABSTRACT
I. INTRODUCTION In order to initiate and conduct clinical trials in humans, and to ultimately market a pharmaceutical product in a specific country, appropriate chemistry, manufacturing, and control (CMC) documentation must be submitted for review and approval by the regulatory authority of that country. In many countries, this CMC documentation must include appropriate information and data to assure the authority that the active pharmaceutical ingredient (API) used in the drug product is manufactured by a robust process and is well controlled to ensure safety and efficacy for the target patient population. The CMC documentation must be updated to reflect changes to the manufacture and control of the API, and frequently these changes must be formally approved by the health authority prior to administration of the material to the patient population. The review and approval of the CMC documentation can be, at the discretion of the health authority, supported by on-site or “field” inspections covering areas such as raw data review, compliance to documented internal practices and procedures, and conformance to current good manufacturing practices (cGMPs). Thus, virtually every aspect of the development, scale-up, and commercial manufacture and control of the API is subject to regulatory oversight.
