Europe – Consultation deadline for revised dosage form monographs and general chapters drawing near

The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the dosage form monographs and related general chapters. Five different texts finalised by Ph. Eur. Group of Experts 12 have been launched for public consultation in Pharmeuropa 31.4 until 31 December 2019.

The general monograph Eye preparations (1163) has been revised to include the additional requirements and mandatory test for sub-visible particle contamination described in the proposed new general chapter 2.9.53. This test will need to be performed for all eye drops and lotions intended for use in surgical procedures or for application to injured eyes. The section on ophthalmic inserts has also been revised to include a test ensuring that the release of the active substance is suitable.

The new general chapter, Particulate contamination: sub-visible particles in non-injectable liquid preparations (2.9.53), describes two methods for evaluating the presence of sub-visible particles in non-parenteral liquid preparations. This chapter provides additional information on other test methods which may be referred to in other monographs in the future. For parenteral preparations, testing for sub-visible particle contamination will continue according to chapter 2.9.19