Spring Intro 2023

03/03/2023

Common Deficiencies - General

• Common problems with MA application:

– Failure to list all the manufacturing sites, Mod. 3.2.S.2.1, Mod. 3.2.P.3.1 and PI) must be consistent regarding their names, detailed addresses and activities. • Listing administration address, instead of the site of manufacture, not listing manufacturers

Poor photocopies submitted, e.g. spectra

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Out of date ASMF and CEP references

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– Letter of access not included in Module 1 (when ASMF used)

– No TSE declaration on materials of animal origin

– QP declarations: not complete, audits out of date (no justification given)

– Footnotes in different parts of Module 3 make reference to various documents e.g. for acceptance criteria etc., but no explanation given and/or details provided. – Statements justifying absence of data or specific eCTD sections should be provided in the relevant Quality overall summary in Module 2. Should any of these documents require updating, the relevant expert's declaration in

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Common Deficiencies Drug Substance

• Most common / most critical deficiencies

Common Deficiencies in CMC

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