Module 3 - Strategic case studies in practice

Table 6 Information That Typically Should Be Submitted for Liquid-Based Oral and Topical Drug Products and for Topical Drug Delivery Systems

Description

Overall general description of container closure system, plus:

For Each Packaging Component: C Name, product code, manufacturer, physical description C Materials of construction (for each: name, manufacturer and product code) C Description of any additional treatments (e.g., procedure for washing components) Protection: (by each component and/or the container closure system, as appropriate) C Light exposure C Reactive gases (e.g., oxygen) C Solvent loss C Moisture permeation (liquid-based oral products would typically meet USP requirements for a tight or class A container) C Microbial contamination (container integrity, increased bioburden, microbial limits, as appropriate) C Seal integrity or leak testing of tubes (topical drug products) and unit dose containers (liquid-based oral drug products) Safety: (for each material of composition, as appropriate) C Chemical composition of all plastics, elastomers, adhesives, etc. a C For most liquid-based oral drug products: appropriate reference to the indirect food additive regulations C For liquid-based oral drug products with chronic dosing regimens that contain alcohol or a cosolvent: information to establish that exposure to extractables will be no greater than that expected to result from the use of similar packaging components when used with foods, or that the exposure is acceptable based on b toxicological data. C For topical drug products (plastic coatings for metal tubes), and plastic drug delivery system components: USP Containers testing C For topical delivery systems: appropriate reference to indirect food additive regulations Compatibility: (for each component of the packaging system, as appropriate) C For LDPE and glass components, USP Containers testing c C For coatings for metal tubes: coating integrity testing Performance: (for the assembled packaging system) C Functionality and/or drug delivery should be addressed, as appropriate. For Each Packaging Component Received by the Applicant: C Applicant's tests and acceptance criteria d 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 Description of the manufacturing process, as appropriate

Suitability

Quality Control

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