IPEC e-newsletter - Excipients Insight October 2017 - 16-10-17

 

Inside this issue

     

PDG meets with IPEC Federation in Rockville

The annual meeting between the IPEC Federation and Pharmacopoeial Discussion Group (PDG) took place on 13 September in Rockville, Maryland, providing an opportunity to review of the PDG’s deliberations from its previous two-day meeting, which takes place ahead of the IPEC discussions, and the development of a ‘to do’ list of projects for the two parties.

IPEC Federation chair Patricia Rafidison (pictured) gave Excipients Insight an update on the deliberations, including a plan to restructure the PDG meeting format to facilitate technical exchange so the face-to-face meeting can focus on strategy.

This includes streamlining the process for the harmonization work programme with the purpose of improving efficiency and developing multiple ways to achieve harmonisation (bilateral, or others), plus other structured ways, e.g. bilateral or other mechanisms under Good Pharmacopoeial Practices. PDG will monitor these activities. 

Both parties’ current projects and plans were discussed, said Rafidison. On the agenda were cellulosics viscosity, pregelatinized starch identification studies, and silicon dioxide on round-robin testing. Elemental impurities harmonised testing methodology and proposals for specific elemental impurities were also covered. Input from the industry on the list of monographs that will retain elemental impurities in their monographs is expected.

There was also discussion on future harmonisation efforts, including integration of other pharmacopoeias such as China and India. PDG says it does not intend to expand but rather to use alternative ways to achieve harmonization with other bodies.

 

 

 

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