Component & Packaging Validation
Ensuring Container/Closure Compatibility & Safety
Ensuring Container/Closure Compatibility & Safety How to Ensure Container and Closure Compatibility and Safety in Pharma Packaging Pharmaceutical packaging does more than contain the drug—it protects its stability, potency, and safety throughout its shelf life. Container and closure systems must be proven compatible with the drug product, inert to its ingredients, and free from risks of contamination. Regulatory agencies including the FDA and EMA mandate rigorous testing and qualification of all packaging components to ensure product integrity and patient safety. This article provides a step-by-step overview of validating container/closure systems in line with GMP, ICH, and pharmacopeial requirements. It covers…