A number of regulatory guidances reference and address evaluations of packaging and delivery systems for pharmaceutical drug products. These guidances recommend that extractables/leachables testing be performed. West Analytical Services' offers a systematic approach for performing extractable/leachable analysis, as well as container closure integrity testing.
Phase I: Qualitative Material Profile
An extraction study proposal will be created to discover the extractables that may potentially migrate from the packaging system, administration system or device into a drug product. The intent of these studies is to determine the extractables from the material and does not result in quantitative data. This first-pass qualitative study will consist of extracting the specified components with multiple solvents and analyzing the samples using a variety of analytical techniques (including Liquid and Gas Chromatography, Mass Spectrometry, and ICP). The data will be evaluated for identification of species and a list of confirmed, confident, tentative, and unknown extractables will be provided.
Phase II: Method Development in the Drug Product
- A Method Development proposal will be written to address method development/optimization of leachables. New methods will be developed dependent on the drug product matrix.
Phase III: Method Validation in the Drug Product
- Method validation is performed in accordance with USP and ICH guidelines and will evaluate linearity, accuracy, precision, minimum quantitable limits (MQL), minimum detectable limits (MDL), specificity, ruggedness, robustness and stability of solutions.
- A validation plan is written and approved for each method.
Phase IV: Stability Samples Analysis
- A program will be developed to monitor leachables during stability of product and quantitate levels during the shelf life of the product.
- Container closure integrity and functional testing should be used as complementary studies.
Guidance for Aseptic Processing
Understanding the recommendations outlined in the FDA’s Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, is important when selecting your packaging components and contract facility partners who support your drug development efforts. The guidance was finalized in September 2004.
Click here to read the guidance. To find out how the guidance may impact your drug product development, click here to contact a West Representative at West the Source.
Below are recommended guidances for packaging: