The American National Standard for excipient GMP: impact on the manufacturer

[...]FDA may adopt the ANSI standard GMP regulations for excipient ingredients manufactured for use in pharmaceutical dosage forms intended for US domestic markets. The first clause in NSF 363 to refer to risk is 4.2.1 (Quality Management System/ Documentation Requirements/General) where the appropriate use of quality risk-management principles, defined as a systematic process for the assessment, control, communication, and review of risks to the quality of the excipient across its life cycle, are to be used to evaluate changes to the quality management system. The suppliers of quality critical raw materials should be expected to notify the manufacturer of a process change so that the excipient manufacturer can evaluate the change for the potential impact to the excipient. * Clause 7.5.5.1 (Production and Service Provision/Preservation of Product/Raw Material Packaging Systems) requires a risk assessment to assure the storage and handling of raw materials provides suitable protection against deterioration or contamination and that identification labels remain legible. * Clause 7.5.5.2 (Production and Service Provision/Preservation of Product/Excipient Packaging Systems) provides for a risk assessment only where reusable containers are returned for further use. [...]the provisions for risk assessment in NSF 363 are new in that they are to be formally conducted and documented.