Packaging Tests According to ICH Guidelines in Medical Pharmaceuticals

The Importance of Packaging in Medical Products

Drug packaging is not merely a means of transportation; it is also a fundamental component that preserves the efficacy, stability, and safety of the drug. Packaging materials provide a barrier against moisture, light, oxygen, and microbial contamination. Therefore, the suitability of packaging materials and systems must be tested and documented in accordance with international standards.

What are ICH Guidelines?

ICH (International Council for Harmonisation) is an organisation that aims to achieve international regulatory harmonisation regarding the quality, safety and efficacy of medicines. Packaging tests are evaluated within the scope of the ICH Q1A (Stability Tests), Q1B (Photostability) and Q3 series guidelines.

Basic Packaging Tests Applied Under ICH

1. Stability Tests (ICH Q1A): These tests verify whether the packaging material maintains the physical and chemical stability of the drug throughout its shelf life. These tests include:

Long-term (25°C/60% RH)
Intermediate (30°C/65% RH)
Accelerated conditions (40°C/75% RH)

under these conditions.

2. Photostability Tests (ICH Q1B): The packaging's ability to protect the product from UV and visible light effects is evaluated. In cases where light-transmitting packaging does not provide effective protection, opaque or protective outer packaging is recommended.

3. Integrity Tests: The packaging is evaluated for its resistance to microbial contamination and air and moisture permeability.

Methods used:

Vacuum decay test
Dye ingress test
Bubble test
Helium leak test

4. Mechanical Resistance Tests: The packaging's resistance to physical impact, pressure, or dropping is tested. These include: 5. Interaction Tests (ICH Q3B, Q3C): The packaging material is evaluated for physical or chemical interaction with the drug. These tests also include analyses of extractable and leachable substances (leachables & extractables).

Drop test
Compression test
Puncture and burst test
Deformation analysis throughout shelf life

Legal Basis for ICH Tests

In drug licensing and GMP inspection processes, compliance of packaging tests with ICH guidelines is mandatory by regulatory authorities such as the Turkish Ministry of Health, EMA, and FDA. Test results must be included in the “Quality” section of the product information file (CTD).

Nanolab Laboratories Group continues to provide services within the scope of Packaging Analysis. You can also consult us on Pharmaceutical Analysis.

For more information, please contact us.

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