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Regular interval for GDP Self-Inspections?

Guidelines on Good Distribution Practice (GDP) of medicinal products for human use (2013/C 343/01) define the need for a self-inspection programme “Self-inspections should be conducted in order to monitor implementation and compliance with GDP principles and to propose necessary corrective measures. A self-inspection programme should be implemented covering all aspects of GDP and compliance with the regulations, guidelines, and procedures within a defined time frame.

Same requirement is also defined in:

  • Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01) “The distributor should conduct and record self-inspections in order to monitor the implementation of and compliance with these guidelines. Regular self-inspections should be performed in accordance with an approved schedule.” and
  • Commission Implementing Regulation (EU) 2021/1248 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 “A self-inspection programme shall be implemented covering all aspects of GDP for veterinary medicinal products and compliance with this Regulation and procedures within a defined time frame. Self-inspections may be divided into several individual self-inspections of limited scope.”
  • Commission Implementing Regulation (EU) 2021/1280 as regards measures on good distribution for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council “shall conduct and record self-inspections in order to monitor the implementation of and compliance with good distribution practice for active substances used as starting materials in veterinary medicinal products laid down in this Regulation. Regular self-inspections shall be performed in accordance with a schedule set out in the quality system.”

The requirements of Regulation and Guidelines are clear, self-inspections should be:

  • conducted to monitor implementation and compliance with GDP principles;
  • implemented covering all aspects of GDP and compliance with the regulations and;
  • carried out according to a schedule set.

However, Regulation and Guidelines do not specify how often self-inspections should be carried out. It is recommended and generally accepted by competent authorities that a risk-based approach is used to determine what areas to cover with what frequency. In majority of cases, self-inspection is conducted at least annually; all relevant areas of GDP covered at least every two to three years and all high-risk activities at least annually.

BILLEV PHARMA EAST d.o.o. can act as an impartial external auditor, help your Company to identify areas where practices are no longer compliant with current GDP Regulations and save your Company a lot of trouble and costs.