Elemental Impurities: Requirements for API Manufacturers

14 December 2018
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14 December 2018, Comments 0

Since June 2016, new registered medicines must have elemental impurities evaluated and controlled. This requirement was extended to existing medicines already on the market in December 2017. The criteria for carrying out the evaluation and monitoring are described in the ICH guideline Q3D. This is one of the guides listed in our post regarding the recent changes introduced in the derived guidelines due to the recent change in GMP compliance paradigm

The responsibility of evaluating and control de element impurities lays on the medicine manufacturers, who should perform a risk analysis to identify potential impurities, a screening to confirm its actual contents and, when required, set up specifications for the expected elemental impurities, with the subsequent routine controls.

The introduction of the Q3D entails a difficulty to the medicines manufacturers provided that one of the main sources of elemental impurities is the raw materials and therefore the level of knowledge that they have is limited. Medicine manufacturers need information about raw materials manufacturing processes in order to comply with the ICH Q3D requirements for evaluation and risk assessment.

Many of the raw materials manufacturers have carried out an important effort to provide effective information to the medicines manufacturers in despite that is not mandatory for raw materials manufacturers to comply with ICH Q3D requirements. They see this as a commercial advantage opportunity to gain the loyalty of the customers and this information is very useful to perform the risk assessment exercise and address the compliance issues introduced by Q3D.

 

Conclusion

At AFA, we are aware of the regulatory requirements for the control of elemental impurities and we have the level of knowledge required, regarding potential sources of impurities, to be able to identify which ones should be tested. In this sense, our approach to audits has introduced the request of having information about the level of elemental impurities in the raw materials used in the medicine formulation. Even though the absence of this information does not entail deviations, it is recommended to perform the subsequent risk assessment to attend the needs of their customers (medicines manufacturers).

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