batch manufacturing record definition

batch manufacturing record or its acronym “BMR” means all documents associated with the manufacture of a batch of bulk product or finished medicinal product;
View Source
batch manufacturing record means the document that sets out in detail the master production instructions and Batch production records as defined in (a) applicable laws and regulations in the United States, including section 211.188 of Tide 21 of the United States Code of Federal Regulations; and (b) Sections 6.4 and 6.5 of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors Part II: Basic Requirements for Active Substances Used as Starting Materials.
View Source

Related to batch manufacturing record

  • API means American Petroleum Institute.

  • Manufacturing Process means any process for—

  • Manufacturing Site means a location where a manufacturing

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.