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News about GMP/cGMP

2016-11-18

ICH: Assembly Meeting in Osaka, Japan

On 5-10 November 2016, the International Council for Harmonisation (ICH) met in Osaka, Japan, for its assembly meeting and has now published a press release.

 

To extend the global outreach is one of the goals of the Council. Therefore, the ICH was pleased to welcome ANVISA (Agência Nacional de Vigilância Sanitária) from Brazil and the Ministry of Food and Drug Safety (MFDS) from South Korea as the first new regulatory Members. As a new industry association member the Biotechnology Innovation Organization (BIO) was introduced.

Furthermore, the following regulatory authorities and international pharmaceutical industry organisation were agreed as ICH Observers:

  • Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED), Cuba
  • National Center for the Expertise of Drugs, Medical Devices and Equipment (National Center), Kazakhstan
  • Medicines Control Council (MCC), South Africa
  • Active Pharmaceutical Ingredients Committee (APIC).

In the area of GMP the following topics can be highlighted:

  • ICH Q11 (Development and manufacturing of drug substances): A question and answer document has been developed to clarify a number of implementation issues, particularly focusing on chemical entity drug substances. The draft document will now be released for stakeholder consultation.
  • ICH Q3C(R6) (Guideline on residual solvents): A new update on the guideline was finalised and adopted for implementation by ICH members.

The next ICH Meeting will be held in Montreal, Canada from 27 May - 1 June 2017.

Source:

ICH: Press release, Osaka


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Literature recommendation
ICH Q8, Q9, Q10
A Process Approach to Pharmaceutical Quality Systems
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