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What is coming? Are you ready for the next FDA and Health Canada inspection?Are you  submitting  new dossier to FDA or Health Canada?

June22, 2018

Elemental Impurities Implementation FDA and Health Canada


Changes to conditions established in approved ANDAs and NDA need to meet PDE recommendations of Q3D or comply with USP <232> PDEs.

On January 1, 2018, new
guidelines regarding elemental impurities in brand and generic drug products went into effect. Elemental impurities, such as arsenic and lead, pose toxicological risks to patients without providing any therapeutic benefit.
These impurities may be present in drug products from a variety of sources, such as interactions with equipment during the drug manufacturing process.

As of January 1, 2018:
All new and existing NDAs and ANDAs for drug products with an official USP monograph are
required to meet the requirements in USP General Chapters <232> and
<233> for the control of elemental impurities. Applicants
submitting NDAs and ANDAs for drug products without a USP monograph are expected to follow

Health Canada

Implementation of elemental impurity risk assessments for new submissions for drug products (ANDS or NDS, S(A)NDS and DIN Applications):

Submissions received by Health Canada after December 31, 2016 should include a risk assessment for elemental impurities. Submissions received after December 31, 2016 that do not have a risk assessment will be requested to submit the missing information.

Risk assessments will be evaluated during the assessment process. The scope of the risk assessment to be submitted for assessment should be based on the principles outlined in the ICH Q3D guideline and related training materials being developed by the ICH Q3D Implementation Working Group. Case studies are currently under development and will be published on the ICH website, when available. Detailed risk assessments and data supporting these risk assessments should be documented and available upon request by the Regulator (e.g., at the inspection stage).

The locations where the elemental impurities-related information can be found in Module 3 should be clearly summarized in Module 2.3.P.5: Control of Drug Product of the Quality Overall Summary.  The overall risk assessment summary for elemental impurities should be placed in Module 3.2.P.5.6 Justification of Specifications. The location of the overall risk assessment summary is currently under discussion by international regulatory authorities. The risk assessment for the container closure system may be cross-referenced to a master file. If toxicology data is submitted to support limits above the ICH Q3C Permitted Daily Exposure or for routes of administration not covered by ICH Q3D, it should be placed in Module Other Toxicity Studies: Impurities.

Compliance with the ICH Q3D guideline should be documented after the risk assessment has been completed and any necessary controls have been implemented. For example, a statement confirming ICH Q3D compliance should be included on the drug product specifications and reflected in the updated Certified Product Information Document (CPID). Additional evidence of compliance should be available on request.

Implementation of elemental impurity risk assessments for Canadian marketed drug products:

S(A)NDSs or Post-DIN Changes for any quality related major change to a drug product (i.e. a new formulation, new drug product manufacturing site, new dosage form) submitted after December 31, 2016 should include a risk assessment for elemental impurities to allow for review and authorization of the S(A)NDS or Post-DIN changes by January 1, 2018. A risk assessment should be performed in accordance with the ICH Q3D guideline and any training materials published as a result of work currently being done by the ICH Q3D implementation working group. Case studies are currently under development and will be published on the ICH website, when available. The risk assessment should be documented and available for inspection and any controls should be implemented, if applicable, by January 1, 2018.


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May 10, 2016

PSG Annual Conference

PharmEng is attending this year's PSG Annual Conference, As a proud supporter of the Pharmaceutical Sciences Group, we hope to see you at the annual conference in Toronto on May 10, 2016!   Please click here to see the conference brochure.


PharmEng Technology Holiday Party 2014

PharmEng Technology hosted its 2014 Christmas Party at Eaton Chelsea in Downtown Toronto on Dec. 13 2014. More than 200 guests, employees and their family members enjoyed this great event with delicious food, outstanding entertainment and tons of prizes! Please click here to see it yourself, and hope we can see you there next time!

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