Design, delivery, and maintenance of manufacturing support facilities, utilities, process equipment, and automation control so that they perform as intended to meet business objectives, such as capacity, yield, operational efficiency, and reliability. Development of a production process that can repeatedly produce a quality product.. The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is.
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Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines.. 1It is a prohibited act under section 301 (e) of the FD&C Act to refuse to permit access to or to refuse copying of any record as required by section 704 (a) of the Act. 2See 21 CFR 211.180 (c.