Classification of GMP Deficiencies - A new Guideline of the PIC/S

Following the PIC/S Committee Meeting in Chicago (USA) at the end of September 2018, the PIC/S announced that the PIC/S working group had elaborated a new guideline on the classification of GMP deficiencies which is going to be adopted. The work on this paper had already begun in 2012 after the topic "classification of GMP deficiencies" had been discussed during the PIC/S meeting in 2011 in South Africa.

The aim of the new document is to provide harmonisation of GMP deficiencies in GMP inspections across the different inspectorates. Indeed, consistency should be ensured throughout the different inspectorates of countries to define when a deficiency is a critical one and when it is a major one.

The paper is to be seen as a tool which facilitates the risk-based classification of GMP observations. On the one hand, it should support  inspectors in their work and on the other hand it should serve as information for the industry on how deficiencies are classified. To that end, the guideline should include examples and be non-binding so that the responsibility for the extent of a deficiency discovered still remains in the hands of the manufacturer inspected.

Moreover, reflection is ongoing on also taking into consideration GDP deficiencies (i.e. inspection findings from Good Distribution Practice inspections) in the guideline.

The new guideline "Classification of GMP-Deficiencies" - which will carry the number PI 040-01 - is to come into force on the 1st of January 2019. It will be previously published on the PIC/S website.

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