Good manufacturing practice
Good Manufacturing Practice[edit | edit source]
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
History[edit | edit source]
The concept of GMP was first introduced in the United States in the 1960s. The Food and Drug Administration (FDA) implemented regulations for the manufacturing of food and pharmaceuticals after a series of incidents related to poor manufacturing practices.
Principles[edit | edit source]
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.
Quality Management[edit | edit source]
The manufacturer must establish and implement an effective Quality Management System (QMS). The QMS must be fully documented and its effectiveness monitored.
Personnel[edit | edit source]
All personnel should be qualified and adequately trained to carry out their responsibilities. They should understand the principles of GMP that apply to their roles.
Premises and Equipment[edit | edit source]
Premises and equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. Their layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance.
Benefits[edit | edit source]
GMP ensures that products are consistently high in quality, from batch to batch, for their intended use. It also ensures that the risks that are inherent in pharmaceutical production are minimized.
See Also[edit | edit source]
Contributors: Prab R. Tumpati, MD