GMPpraksis

GMPpraksis, or Good Manufacturing Practice, refers to a system of processes and procedures designed to ensure that medicines and related products are consistently produced and controlled according to quality standards appropriate for their intended use. The aim is to minimize risks such as contamination, mix-ups, and errors that could affect product quality, safety, or efficacy.

GMPpraksis encompasses a broad set of requirements. Core elements include a quality management system, qualified and trained personnel, appropriate premises and equipment, documented procedures, and robust record-keeping. Production and quality control activities must be validated and controlled, with change management, supplier qualification, and validated cleaning procedures. Batch release typically requires review by qualified personnel, and there are established processes for handling deviations, investigations, corrective and preventive actions (CAPA), recalls, and product complaints.

Regulatory framework and enforcement vary by jurisdiction but share common objectives. In the European Union, GMP is implemented under EU directives and EudraLex regulations, with inspections conducted by national authorities. In the United States, GMP requirements are enforced by the FDA under 21 CFR Parts 210–211. International guidance is provided by the ICH, for example ICH Q7 for APIs, and by the WHO. Inspections can result in deficiency letters, import alerts, product seizures, or marketing authorization actions if standards are not met.

Implementation typically involves establishing a quality management system, qualification and validation of equipment and processes (IQ/OQ/PQ), ongoing quality control, documentation of all activities, and continuous improvement through CAPA. GMPpraksis also interfaces with related GxP standards, such as GLP for testing and GCP for clinical research, and is harmonized to varying degrees by international collaboration and mutual recognition programs.