Extractable and leachables testing is a profoundly elaborate and challenging subject, not only from a scientific position but also concerning regulatory requirements. The control of elemental impurities from plastics in contact with pharmaceutical products, whether through production or packaging material, is an area of particular importance to healthcare authorities and this is reflected in the number of new and draft chapters governing testing procedures.
The ICH Q3D guideline on elemental impurities requires the application of a risk-based approach to testing in general which includes extractable elements from plastics used in the production or packaging of pharmaceutical products. Changes in extractable testing requirements are underway in both the European Pharmacopoeia (Ph. Eur) and the United States Pharmacopeia-National Formulary (USP-NF) which will impact the control of containers, closure systems and manufacturing equipment in the coming months and years.
To help you stay up-to-date on these evolving requirements, Solvias has published a special report. What are the current changes, draft chapters and open issues that will impact your routine testing and validation requirements? Our experts have studied the subject in detail and compiled their findings in a free white paper entitled, “Plastic Materials for Pharmaceutical Use: Changes in Testing of Extractable Elements According to Ph. Eur and USP-NF.”
Ensure you have the latest information to avoid non-compliance or delays in implementation once the new regulation is official. Please fill out the enquiry form to find out more.