Comment from Perrigo Company

Perrigo Company Comments on: M4Q (R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality, Guidance for Industry (docket FDA-2025- D-2275) 1.Please provide clarification on which sections of M2 may be satisfied by making reference to a Drug Master File which is owned by a different company. For example, 2.3.2.3 Overall Control Strategy Representation (line 110) does note that reference to a DMF may fulfill the requirements, but a similar note does not exist for 2.3.3.DS Drug Substances (line 135). 2.Please provide clarification on the requirement for and incorporation of Reference Standard information to support analytical method validation activities. For example, section 2.3.3.RS Reference Standards and/or Materials (line 349) only makes mention of those standards and/or materials used for testing of drug substance, drug product, or intermediates. Does the term “testing” include analytical method validation? 3.Refer to 2.3.4.IN.2.1 Integrated justifications of extractables and leachables (line 660) and to 2.3.4.IN.2.3 Development and justifications for products without a defined and/or isolated drug substance (line 686). Recommend adding the phrase “If Applicable” as is done in line 711, or “Optional” as is done in line 702. Further recommend adding such text to all sections that may only be required under certain circumstances. 4.Please provide clarification relating to 2.3.4.IN.3.2 Summary and Justifications of sameness with a product approved in a reference country, if a reliance procedure is used (line 722). What is a “reference country” and when would it be appropriate to establish sameness to a product from a reference country?