Elemental impurities: EMA delays September 1st application of related guideline for existing drug products, ICH Q3D has entered step 2b – see following update and related references!

Besides other impurities such as residual solvents and other, potentially genotoxic impurities, elemental impurities (=heavy metals) play an important role in the current update of the ICH Q3X series of regulations. More specifically, elemental impurities are dealt with in ICH Q3D, which has entered just recently step 2b. Aim of this guideline is to control the level of metal impurities in medicinal products, as this is done with the ICH Q3A – C series of guidelines for other impurities and residual solvents.

aAt the same time, the adoption into regional regulations and pharmacopoeias, such as the European Pharmacopoeia (Pharm. Eur.) and United States Pharmacopoeia (USP), has been deferred in order to address concerns of industry organizations and to inter-nationally harmonize the application of the same standards. Thereby the USP General Chapters <232> Limits and <233> Procedures on Elemental Impurities as well as the Pharm. Eur. Chapter 5.20 (Metal catalyst or metal reagent residue) and the related reference in the General Monograph 2034 “Substances for pharmaceutical use” have been deferred. In addition, the Committee for Medicinal Products for Human Use (CHMP) decided to delay the application of the current EMA Guideline on the specification limits for residues of metal catalysts or metal reagents (EMEA/CHMP/SWP/4446/2000) to existing marketed products, which should have become applicable to existing marketed products as of 1 September 2013. At the same time the ICH Q3D guideline was adopted for public consultation until December 31st, 2013 as document EMA/CHMP/ICH/353369/2013.

API imports into Europe – two months after July 2nd implementation date

Two months after July 2nd implementation date for new regulations on API imports into Europe, the market supply with drug products and APIs in Europe seems not to be negatively affected, as it was suspected by several involved parties. This is at least the consequence, we at blue inspection body conclude, based upon ongoing discussions with our customers and evaluating the related press releases. It will be quite interesting in this regard to also further monitor the feedback from EU health authorities. MHRA from UK did announce, that related surveillance of imports according to the regulations in place, will only be conducted at the plants and not at the borders e.g. during customs clearing (see related information from in-pharmatechnologist.com). Furthermore, an additional Q&A document has been published by the Danish Health and Medicines Agency and another guideline by the Heads of Medicines Agencies concerning API imports (see below).

References concerning this topic:

EXCiPACT – Pilot phase completed and first certificates issued

Mid of July, EXCiPACT, a voluntary international scheme to provide independent 3rd party certification of manufacturers, suppliers and distributors of pharmaceutical excipients, announced the completion of the pilot phase and also the issuance of the first related EXCiPACT certificates to the companies involved. Further excipient companies are participating in the scheme and additional EXCiPACT training courses are scheduled in Europe and the US for October and November, respectively.

See the following links for further reference.

Major GxP Events III & IV/2013