Good Manufacturing Practice (GMP)

The European GMP guidelines are binding rules for quality assurance of pharmaceutical production processes and their environment in the production of drugs, such as DCs and active ingredients to ensure that a manufactured product is safe for use.

All guidelines follow some basic principles:

  1. Manufacturing facilities must be clean and hygienic.

  2. Production facilities must maintain controlled environmental conditions.

  3. Manufacturing processes must be clearly defined, possibly validated and controlled.

  4. Instructions and procedures must be written in clear and unambiguous language using good documentation practices.

  5. The records must be made manually or electronically during manufacture, indicating that all steps required by the procedures and instructions specified have actually been performed.

  6. The staff must be trained to carry out and document the procedures.

  7. Deviations must be examined and documented.

  8. Records of manufacture that enable tracking the entire history of a batch must be kept in an understandable and accessible form.

The aim of the guidelines is to ensure a documented consistent high quality of the manufactured product.