Good manufacturing practice

Good Manufacturing Practice

File:Good Manufacturing Practice logo.jpg

Good Manufacturing Practice logo

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

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

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

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Quality Management System

The manufacturer must establish and implement an effective Quality Management System (QMS). The QMS must be fully documented and its effectiveness monitored.

Personnel

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

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

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

• Quality control
• Quality assurance
• Regulatory compliance