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Operators must be trained to carry out and document procedures. Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected.
The Michigan Department of Licensing and Regulation was abolished with most responsibilities transferred to the newly formed Department. [1] It was renamed the Department of Consumer and Industry Services under an executive order issued in 1996 by Governor John Engler , merging most of the Department of Labor within the Department of Commerce ...
The Michigan Occupational Safety and Health Administration (MIOSHA) is a state government agency that regulates workplace safety and health in the U.S. state of Michigan. Michigan OSHA is an agency within the Michigan Department of Licensing and Regulatory Affairs, and operates under a formal state-plan agreement with the Occupational Safety ...
Michigan Department of Licensing and Regulation, abolished by Governor Engler with most of the department transfer to the Department of Commerce until Commerce was split up with the former L&R powers transferred to the Department of Consumer and Industry Services [1]
The Michigan Strategic Fund would take over the State Land Bank Fast Track Authority from the Michigan State Housing Development Authority. [4] The Michigan Department of Talent and Economic Development came into existence on March 16, 2015 with the department's first director being Steve Arwood, concurrently CEO of the MEDC. TIA's first head ...
In the UK, computer validation is covered in Annex 11 of the EU GMP regulations (EMEA 2011). The FDA introduced 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997). The FDA regulation is harmonized with ISO 8402:1994, [6] which treats "verification" and "validation" as separate and distinct terms.
The GAMP 5 standard recommends an approach to the creation of the plan. [3]Topics commonly covered include: Introduction, scope, responsibilities, description of facility and design, building and plant Layout, cleanrooms and associated controlled environments, storage areas, personnel, personnel and material Flow, water and solid waste handling, infrastructure and utilities, water system ...
A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organization in the pharma industry, is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive ...