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`CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
`205552Orig2s000
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`MICROBIOLOGY / VIROLOGY REVIEW(S)
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`M E M O R A N D U M
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`DATE:
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`TO:
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`FROM:
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`THROUGH:
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`cc:
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`SUBJECT:
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
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`8 July 2013
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`NDA 205552
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`Bryan S. Riley, Ph.D.
`Team Leader (Acting)
`OPS/New Drug Microbiology Staff
`
`Stephen E. Langille, Ph.D.
`Senior Review Microbiologist
`OPS/New Drug Microbiology Staff
`
`Diane C. Hanner
`Senior Program Management Officer
`OND/DHP
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`Product Quality Microbiology assessment of Microbial Limits for
`Ibrutinib 140 mg Capsules [Submission Date: 28 June 2013]
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`
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`The Microbial Limits specification for Ibrutinib 140 mg Capsules is acceptable from a
`Product Quality Microbiology perspective. Therefore, this submission is recommended for
`approval from the standpoint of product quality microbiology.
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`Ibrutinib 140 mg Capsules are for oral administration.
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`The drug product is tested for Microbial Limits at release using a method consistent with USP
`Chapter <61> (Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests)
`and <62>
`(Microbiological Examination of Non-sterile Products: Tests
`for Specified
`Microorganisms). The Microbial Limits acceptance criteria are consistent with USP Chapter <1111>
`(Microbiological Examination of Non-sterile Products: Acceptance Criteria for Pharmaceutical
`Preparations and Substances for Pharmaceutical Use).
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`Reference ID: 3338318
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`M E M O R A N D U M
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`Absent
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`Method
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`USP <61>
`USP <61>
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`USP <62>
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`Table 1 – Microbial Limits Specification
`Test
`Acceptance Criteria
`Total Aerobic Count
`NMT
`Total Combined Yeast and
`NMT
`Mold Count
`E. coli
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`The Microbial Limits test methods were verified to be appropriate for use with the drug product
`following procedures consistent with those in USP Chapter <61> and <62>.
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`The drug product will also be tested for Microbial Limits annually as part of the post-approval
`stability protocol.
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`ADEQUATE
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`Reviewer Comments – The microbiological quality of the drug product is controlled via a
`suitable testing protocol.
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`END
`
`
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`Reference ID: 3338318
`
`(b) (4)
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`
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`BRYAN S RILEY
`07/09/2013
`
`STEPHEN E LANGILLE
`07/09/2013
`
`Reference ID: 3338318
`
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