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' PakProfile™ is a systematic approach for performing extractable/leachable analysis, as well as container closure integrity testing.
PakProfile™ is a phased approach for extractables/leachables testing.
Phase I: Accelerated Method Development-Feasibility in Drug Product
- If base methods are not available, quantitative test methods will be developed for each extractable with suitable detection limits and range.
- If base methods are available, method feasibility will be done to determine if these methods are acceptable with suitable detection limits and range.
*All methods must be validated for further studies to meet criteria in the regulatory guidances.
Phase II: Method Development of Remaining Methods
- A Method Development proposal will be written to address method development/optimization of the remaining non-feasible methods at the client’s direction. Some methods may be rapidly developed by optimization of the non-feasible methods or where appropriate, 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 Technical Customer Support Representative at West the Source™.
Below are recommended guidances for packaging: