FlexTalk Friday: Top Pharmaceutical Packaging Regulations To Be Aware Of

September 16, 2021 by FlexPro

What are some of the pharmaceutical packaging regulations that focus packaging engineers’ time and energy to ensure compliance?

Pharmaceutical packaging is a highly diverse discipline based on the design and regulatory requirements of the range of drug therapies and related drug substances— Having a good working knowledge of the regulations and FDA guidance is a good place to start to ensure that your packaging development efforts are focused for compliance and commercial success.

Small Molecule Pharmaceuticals

Regulatory guidance for Container Closure systems for the most common types of dosage forms can be divided into five general categories:

  • Inhalation drug products
  • Drug products for injection and ophthalmic drug products
  • Liquid based oral and topical drug products and topical delivery systems
  • Solid oral dosage forms and powders for reconstitution
  • Other dosage forms
  • The Center for Drug Evaluation and Research (CDER) regulates these products and the Code of Federal Regulations 21 CFR Part 211—current good manufacturing practices for finished pharmaceuticals are applicable. Specifically, 21 CFR 211.94 outlines the requirements for drug product containers and closures.
    • OTC drug products require tamper resistance in compliance with 21 CFR 211.132
    • OTC drug preparations also require Special Packaging per 16 CFR 1700-1702 to prevent serious personal injury or illness for children—The U.S. Consumer Products Safety Commission has responsibility for enforcing the Poison Prevention Packaging Act. The PPPA has also established performance standards and test methods that determine if a packaging system is child-resistant and adult-use effective (16 CFR 1700.15 and 16 CFR 1700.20, respectively).

Biologics, Including Cell & Gene Therapies

FDA Guidance for Industry: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs):

  • The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy.
  • Cell and gene therapy investigational new drug: investigational product (21 Code of Federal Regulations (CFR) 312.23(a)(7)(i)). Drug substance (DS) (21 CFR 312.23(a)(7)(iv)(a)) and the Drug Product (DP) (21 CFR 312.23(a)(7)(iv)(b)).

Stay tuned for our next blog post, where we will take a deeper dive into the elements of qualification and quality control of packaging components for drugs and biologics.

Interested in learning about how you can benefit from our Packaging Engineers? Book a discovery call with us today!

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