Previous

4. Good Manufacturing Practice (GMP)

All medicines should be produced according to Good Manufacturing Practice (GMP) before being administered to humans. This accounts also for generic medicines and biosimilars.

GMP guidelines give direction for manufacturing, testing, and quality assurance, in order to ensure that a medicine is safe for use in humans. Many countries have specific laws and regulations that require pharmaceutical and medical device manufacturers to follow GMP procedures. Most regulations are based on guidelines that are agreed to internationally.

The GMP guidelines follow a few basic principles:

  • Hygiene: Pharmaceutical manufacturing facilities must be maintained clean.
  • Controlled environmental conditions: Cross contamination of a medicinal product from another compound or unrelated particulate matters must be prevented. It could make the medicine unsafe for use in humans.
  • Manufacturing processes are clearly defined and controlled:
    • All critical processes are validated to ensure they are consistent and compliant with specifications.
    • Any changes to processes are evaluated.
    • Changes that have an impact on the quality of the medicine are validated as necessary.
    • Instructions and procedures are written in clear language that cannot be misunderstood. (Good Documentation Practices - GDP).
    • Operators are trained to carry out and document procedures.
  • Records are generated, either manually or by instruments: this must be done during manufacture to prove that all the steps in the defined procedures and instructions were actually carried out. Also, that the quantity and quality of the medicine are as expected.
  • Deviations are investigated and documented.
  • Records of manufacture (including distribution) are retained in full and accessible form. This will make it possible to trace the complete history of a batch.
  • The distribution of the medicines minimizes any risk to their quality.
  • A system is available so that any batch of medicine can be recalled from sale or supply.
  • Complaints about marketed medicines are examined: The causes of quality defects must be  investigated, and appropriate measures taken with respect to the defective medicines. Also to prevent that they recur.

The goal of these good practices is to protect the health of patients and produce good quality medicinal products, medical devices, or active substances. Both in the EU and many other parts of the world it is mandatory to comply with GMP.

Further Reading (optional)

GMP Guidelines:

Previous