How often should GDP Self-Inspections be performed?

Recommendation

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According to the GDP guidelines, regular self-inspections should be performed. But what is considered as an appropriate regular interval?

Regulatory Requirements

The GDP guidelines define the need for a self-inspection programme:

• Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
  Chapter 8.1: Self-inspections should be conducted in order to monitor implementation and compliance with GDP principles and to propose necessary corrective measures.
  Chapter 8.2: 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. Self-inspections may be divided into several individual self-inspections of limited scope.
  
• Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)
  Chapter 8.1: 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.
  
• Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
  Article 35: A self-inspection programme shall be implemented covering all aspects of good distribution practice for veterinary medicinal products and compliance with this Regulation and procedures within a defined time frame.
  Article 36: (1) Self-inspections may be divided into several individual self-inspections of limited scope. [...]
  
• Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice 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
  Article 23: (1) The persons referred to in Article 1(2) 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. (2) Regular self-inspections shall be performed in accordance with a schedule set out in the quality system.

Thus, self-inspections should be conducted in order to monitor implementation and compliance with GDP principles.

Frequency of Self-Inspections

The GDP guidelines do not specify how often self-inspections should be carried out. However, the following aspects have proven to be useful:

• Self-inspections should be carried out according to a schedule set.
• A risk-based approach should be used to determine what areas to cover with what frequency.
• Self-inspection should be at least annual.
• All relevant areas of GDP should be covered at least every 2-3 years and all high risk activities at least annually.