GMP – Guide to Good Manufacturing Practices for Pharmaceuticals

3. Pharmaceutical principles and GMP standards

GMPs’, including those for the pharmaceutical industry, are based on several principles:

1. GMP and quality control:
   Thanks to GMP, the production process is interspersed with strict controls. By intervening at different stages, these quality controls ensure adherence to standards and guarantee compliance with specifications.
2. GMP and hygiene:
   Good manufacturing practices formalize hygiene standards for personnel, premises, industrial facilities and equipment.
3. GMP and training:
   Regularly raising awareness and training staff on GMP facilitates adherence to operations and procedures, as well as the continuous improvement of manufacturing processes.
4. GMP and documentation:
   GMP formalizes all stages of industrial manufacturing through the issuance of documents ensuring the traceability of operations and GMP audits. All manufacturing activities are recorded in detail, from production batches to quality controls and corrective actions. The documentation allows tracing the history of each product batch.
5. GMP and validation:
   Documented validation provides proof of the monitoring carried out on equipment, production tools, handling, processes and more. It also demonstrates that products resulting from GMP are compliant with specifications. The main confirmations concern the validation of processes, cleaning operations, computer systems, and analytical methods.
6. GMP and audits:
   Regular and unannounced audits ensure compliance with GMP. By identifying non-conformities to procedures, the audits facilitate the rapid implementation of corrective actions.