Regarding biotechnology/biomanufacturing, do cGMPs represent only the views of the FDA?
Regarding biotechnology/biomanufacturing, do cGMPs represent only the views of the FDA?
Homework Answers
cGMP(current Good Manufacturing Process) defines quality measures for both production and quality control and defines general measures to ensure that processes needed for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. cGMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific cGMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general cGMP requirements.
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Regarding biotechnology/biomanufacturing, do cGMPs represent
only the views of the FDA?
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