Determining Suitability of Drugs & Biologics Through Pharmaceutical Packaging Qualification & Quality Control
November 2, 2021 by FlexPro
The qualification and quality control of packaging components are essential activities to receive either CDER (FDA Center for Drug Evaluation and Research) or CBER (FDA Center for Biologics Evaluation and Research) approval of a container closure system to be used in the packaging of a human drug or biologic. The relevant data is provided within the application (NDA, new drug application, ANDA, abbreviated drug application and BLA, biologics license application) to the FDA. The overall focus for FDA approval is to provide data that the proposed container closure system and its components are suitable for intended use.
Suitability for intended use can be summarized as follows:
Compendial or pharmacopeial testing on packaging materials are requirements for most regulatory submissions. The United States Pharmacopeia (USP) is a scientific, nonprofit organization that sets federally recognized public standards of quality for medicines, dietary supplements, and foods.
Below are U.S. Pharmacopeia/National Formulary standards used in the testing for “suitability for intended use” for container closure systems; tools to guide your qualification and quality control of packaging components for drugs and biologics:
General Tests and Assays
<51> Antimicrobial preservations—Effectiveness
<61> Microbial limit tests
<71> Sterility tests
<87> Biological reactivity tests, in vitro
<88> Biological reactivity tests, in vivo
<161> Transfusions and infusion assemblies
<381> Elastomeric closure for injections
Biologic Test Procedures
<671> Containers—Permeation, moisture
<771> Ophthalmic ointments
<1151> Pharmaceutical dosage forms
As the demonstration of suitability for intended use is essential to obtaining regulatory approval, the successful execution of appropriate qualifications of the packaging components, as well as the implementation of effective quality control processes is a business and quality system imperative to commercialize your drug product.
Book a 15-minute discovery call today to explore how our elite professionals at FlexPro can support your packaging initiatives.
Reference: Guidance for Industry–Container Closure Systems for Packaging–Human Drugs and Biologics, CHEMISTRY, MANUFACTURING, AND CONTROLS DOCUMENTATION