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By Tonya Chalfant, SME Process Engineer


When developing a global pharmaceutical packaging presentation for an oral product, the regulations that each packaging component must meet can be overwhelming. Start with identifying your primary markets. The United States and the European Union cover some of the largest markets and many smaller markets recognize their standards.

Here’s where you should start to ensure your packaging will be compliant:

1. United States Pharmacopeia (USP) sets guidelines for medicines and food ingredients quality standards. Regulatory agencies and industry use these guidelines to ensure that products meet identity, strength, quality, and safety. Listed below are specific chapters to review for your product:

  • Chapters <1663> and <1664> outline the assessment of extractables and leachables for drug product contact material.
  • Chapters <660> and <661> focus on material selection and associated material testing.
  • Chapter <659> guides packaging and storage requirements for pharmaceutical products.
  • Chapter <671> outline testing for the performance of the packaging components as a complete system. For example, container closure integrity and suggested application torques of a screw on closure.

2. United States Code of Federal Regulations (CFR) – US 21 CFR governs food and drugs within the United States for the Food and Drug Administration (FDA). For packaging requirements, start with 21 CFR 182-186 for a list of materials that are generally recognized as safe (GRAS) for food packaging.

3. European Pharmacopeia (EP) is the equivalent to the USP for the European Union. There are important differences in test methods used depending on the material type, i.e. glass or polyolefins. EP testing is, in general, more prescriptive than USP testing.

4. European Medicines Agency (EMA) – Guideline on Plastic Immediate Packaging Materials discusses what will need to be submitted to the governing agency and when to complete the testing outlined in the European Pharmacopeia.

5. FDA Guidance, “Container Closure System for Packaging Human Drugs and Biologics” describes the submission of the USP testing results to support protection, compatibility, safety, and performance of the packaging system.

6. Environmental Regulations concerning heavy metals, ozone depleting substances, phthalates and substances of very high concern as listed by REACH (Registration, Evaluation, Authorization and Restriction of Chemicals), as well as others, will need to be met prior to marketing.

7. Animal-derived materials are concerns due to bovine spongiform encephalopathy (BSE) and transmissible spongiform encephalopathies (TSE) – neurodegenerative diseases transmissible from animals to humans. Often a supplier can provide a written statement that no substances of animal derivation are present in their materials.

8. For proprietary information that a vendor may not want to disclose, a vendor can submit a Drug Master File (DMF) with the FDA. The DMF contains details about the packaging material that may affect product safety. A vendor will provide authorization for the drug master file to be referenced in the drug submission.

Keeping up with changes in regulations requires routine reviews of compendia standards and guidance. Cultivate working relationships with selected vendors and focus on regulation updates to stay ahead of changes in materials and the associated regulations.

To learn more about how to meet regulations, connect with our experts.