Module 3 - Strategic case studies in practice

Table 3 Information That Should Be Submitted in an Original Application for Any Drug Product Description Overall general description of the container closure system, plus:

For Each Packaging Component: C Name, product code, manufacturer, physical description C Materials of construction (for each: name, manufacturer, product code) C Description of any additional treatments or preparations Protection: (By each component and/or the container closure system, as appropriate) C Light exposure C Reactive gases (e.g., oxygen) C Moisture permeation C Solvent loss or leakage C Microbial contamination(sterility/container integrity, increased bioburden, microbial limits) C Filth C Other Safety: (for each material of construction, as appropriate) C Chemical composition of all plastics, elastomers, adhesives, etc. a C Extractables, as appropriate for the material b Extraction/toxicological evaluation studies, as appropriate Appropriate USP testing Other studies as appropriate Compatibility: (for each component and/or the packaging system, as appropriate) C Component/dosage form interaction, USP methods are typically accepted C May also be addressed in post-approval stability studies Performance: (for the assembled packaging system) C Functionality and/or drug delivery, as appropriate Appropriate reference to the indirect food additive regulations (21 CFR 174-186) C

Suitability

Quality Control

For Each Packaging Component Received by the Applicant: C Applicant's tests and acceptance criteria c C Dimensional (drawing) and performance criteria C Method to monitor consistency in composition, as appropriate For Each Packaging Component Provided by the Supplier: C Manufacturer's acceptance criteria for release, as appropriate C Brief description of the manufacturing process

C

Stability See section III.C.4 Including any additives used in the manufacture of a packaging component a See Attachment C for further discussion of extraction studies. Testing of plastics should be performed on the b packaging component, not on the unformed resin. For a blow/fill/seal product, extractables should be evaluated on the formed drug product container itself. This also applies to a container closure system which is manufactured as part of the drug product manufacturing process. Note that an applicant's acceptance tests may include, among others, test parameters indicated under the description, c suitability, and quality control sections of this table.

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