News about GMP/cGMP

02.08.2016

PIC/S Committee Meeting and Seminar 2016

From 4 to 8 July 2016, the MHRA hosted the following events in Manchester (UK): PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar.

 

Some of the GMP key issues from all events:

  • The PIC/S Committee invited Thailand’s Food and Drug Administration (Thai FDA) to join the Scheme from 1 August 2016. Thai FDA will become PIC/S’ 49th Participating Authority.
  • The PIC/S Inspectorates’ Academy (PIA) is now up and running. The PIA is a PIC/S initiative to set up a web-based educational centre under the PIC/S umbrella which aims at harmonising and standardising GMP training at an international level through a certified qualification system.
  • The PIC/S Working Group (WG) on Data Integrity has completed a first draft guidance document on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments. This first draft guidance has been developed in order to provide an interpretation of existing GMP / GDP data integrity requirements. It sets out basic expectations for good data governance and refers to the influence of organisational behaviour and global supply chain challenges. It is foreseen that this guidance will be published as a draft in the course of August 2016 - for implementation on a trial-basis - as work continues to revise and expand the draft guidance, in particular relating to computerised systems.
  • The EMA (European Medicines Agency) – PIC/S Joint Drafting Group on the revision of Annex 1 (sterile manufacturing) of the PIC/S-EU GMP Guide is in the process of revising Annex 1 and a first draft will be issued shortly for PIC/S and EMA internal consultations. A joint public consultation with the EMA will be organised at a later stage.
  • The PIC/S Working Group (WG) on Controlling Cross-Contamination in Shared Facilities has drafted an Aide Memoire which will focus on harmonising / standardising terminology used in relation with the control of cross-contamination in shared facilities and address questions which inspectors should ask themselves during inspections– in particular in relation with risk management. An internal consultation will shortly be carried out within PIC/S.

More details on the discussions and outcomes can be found in the PIC/S press release dated 01 August 2016.


Source:

PIC/S: Press release: PIC/S Meetings in Manchester

 



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