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News about GMP/cGMP

2017-02-14

ICH: Meeting Minutes of Osaka

The ICH has now published the Meeting Minutes of the ICH Assembly meeting which was held in Osaka, Japan in November 2016. Following you will find the key points on guidance progress in the area of GMP and on new members and observers in brief:

 

New members approved by the Assembly are:

  • The Agência Nacional de Vigilância Sanitária (ANVISA, Brazil)
  • The Biotechnology Innovation Organisation (BIO)
  • The Ministry of Food and Drug Safety (MFDS, Korea).

New observers are:

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

 

For ICH Q12 on Pharmaceutical Product Lifecycle Management the following chapters have meanwhile been prepared:

  • Established Conditions
  • Post Approval Change Management Protocols
  • Product Lifecycle Management Strategy
  • Effective Pharmaceutical Quality System (Change Management)
  • Categorisation of change und data requirements, and
  • The application of Q12 for currently marketed products and lifecycle management plan.
the Assembly noted the Q12 EWG’s request for an interim meeting in April 2017 to continue progress on finalizing the Step 1 document in order to reach Step 1 and Step 2a/b in June 2017 - See more at: http://www.raps.org/Regulatory-Focus/News/2017/02/08/26791/ICH-Offers-Updates-on-New-Members-Progress-on-Guidelines/#sthash.qDNt8F0s.dpuf
the Assembly noted the Q12 EWG’s request for an interim meeting in April 2017 to continue progress on finalizing the Step 1 document in order to reach Step 1 and Step 2a/b in June 2017 - See more at: http://www.raps.org/Regulatory-Focus/News/2017/02/08/26791/ICH-Offers-Updates-on-New-Members-Progress-on-Guidelines/#sthash.qDNt8F0s.dpuf

Furthermore, the Assembly noted the Q12 EWG’s request for an interim meeting in April 2017 to continue progress on finalizing the Step 1 document in order to reach Step 1 and Step 2a/b in June 2017.

M10 (Bioanalytical Method Validation):

  • A first draft technical document is being prepared by the M10 EWG. The Assembly endorsed the work plan.

ICH Q3C (Guideline on Residual Solvents):

  • The Regulatory Experts signed-off Step 3 of the guideline.
  • The Regulatory Members of the Assembly adopted Step 4 of the guideline as final.
  • The role of Rapporteur will rotate to FDA in 2017.
  • The Maintenance EVW will provide a workplan for further activities.

ICH Q3D (Guideline for Elemental Impurities) Maintenance EWG:

  • The training package is finalised and published on the ICH website.
  • The EWG has updated its concept paper and will begin to work on developing PDEs and permitted concentrations of elemental impurities for products administered by the cutaneous and transdermall route of administration.
ICH Q11 (Q&As on API Starting Materials)
  • Step 1 was signed-off
  • Step 2a was endorsed by the Assembly Members
  • Step 2b was endorsed by the Regulatory Members of the Assembly.

A next meeting of the Assembly Members is scheduled for May 27 - June 1, 2017 in Montreal, Canada.

 

Source:

ICH: Osaka Meeting Minutes

 


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Literature recommendation
ICH Q8, Q9, Q10
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