Elemental impurities: Updates on USP, ICH and EMA guidelines

The pharmaceutical industry is faced with an evolving number of guidelines that affect the control of elements -- primarily metals -- for drug products and ingredients such as APIs and excipients. At Merck, we not only understand the importance of being compliant with these existing and upcoming regulations, but also strive to continuously inform you on the current state of each of the metal guidelines.

ICH Q3D: consulting period has begun

The ICH Q3D Guideline for Elemental Impurities is designed to provide a global policy for limiting elemental impurities qualitatively and quantitatively in drug products. Of course, proper control of elemental impurities of the ingredients plays a vital role to assess the contamination risk in the final drug product. This guideline is currently in the consultation period, in which it leaves the ICH process and becomes the subject of normal regulatory consultation in EU, U.S. and Japan.

USP: general chapters deferment

Implementation of the USP general chapters on Elemental Impurities was deferred indefinitely in May 2013 since they intend to work with ICH Q3D to align their activities.

EMA: metal guideline effective for new drug products only

The EMA metal guideline, formally known as "Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents," is already officially effective for new drug products at this time. While there was a recent deferment to harmonize better with impending ICH requirements, it will only affect existing drugs that have not had to meet these requirements before.

At Merck, we are committed to following the EMA guideline given that it is effective for new drugs. Once adopted, ICH Q3D will replace the EMA guideline, which will also have an impact on its reproduction in the European Pharmacopoeia. There currently has been no final decision whether ICH Q3D will actually be incorporated in the European Pharmacopoeia. While there's no projected implementation date for the ICH Q3D guideline set, we are closely watching its development.

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