Documentation and record keeping
GMP emphasises the importance of thorough documentation throughout the manufacturing process. This includes maintaining detailed records of procedures, processes, and actions taken during production.
Quality management system (QMS)
Implementing a comprehensive Quality Management System is a fundamental aspect of GMP. This involves establishing and following documented procedures, as well as conducting regular audits to ensure compliance.
Facility and equipment
GMP dictates that manufacturing facilities and equipment should be designed, constructed, and maintained to ensure the production of high-quality products. This includes cleanliness, hygiene, and appropriate calibration of equipment.
Raw materials and components
GMP emphasises the need for quality control in the selection and testing of raw materials and components. Manufacturers are expected to verify the identity, purity, and quality of all materials used in the production process.
Packaging and labelling
GMP extends to the packaging and labelling of products. It ensures that packaging materials are suitable for their intended use, and labelling is accurate and meets regulatory requirements.
Validation and qualification
Manufacturers must validate and qualify critical processes and systems to ensure that they consistently produce the desired quality. This includes validating equipment, processes, and analytical methods.
