Observance of guidelines of good manufacturing practice

The manufacturer of medicinal products must ensure that production procedures are conducted in accordance with the principles and guidelines of good manufacturing practice. This provision also applies to medicinal products intended for export or removal from the market.

The principles and guidelines of good manufacturing practice include:

  •  A quality assurance system;
  • appropriate staff;
  • appropriate premises and equipment;
  • suitable documentation;
  • suitable production procedures;
  • quality control;
  • suitably arranged contract work;
  • complaints, product recall and emergency unblinding;
  • internal control;
  • labelling of medicinal products for clinical trial;
  • keeping records on medicinal products used in veterinary medicine -
which are described in more detail in the Rules on conditions for completing activities of making medicinals and determining the conditions and procedure of publishing or revoking the execution of good production practices and in the publication, “The Rules Governing Medicinal Products in the European Union, Volume 4 – Good Manufacturing Practices, Medicinal Products for Human and Veterinary Use, 1998 Edition, European Commission, Directorate General III – Industry, Pharmaceutical and Cosmetics” with all amendments.

Supporting evidence

Certificate of good manufacturing practice

Last updated: 08. 01. 2016