Packaging and labeling are the final segment of six key components that make up the quality system which was put in place for pharmaceutical products by the FDA. Any drug product must comply with the federally accepted standards of packaging and labeling to remain in compliance with these regulations while protecting consumers and product integrity.
Furthermore, compliant product packaging and labeling helps companies to avoid the costs and liability associated with recalls. The most common reasons for product recall events pertaining to packaging include defective containers, incorrect packaging containers, and errors in labeling. Learn about packaging protections and how we can help ensure your packaging is compliant with federal regulations and compatible with your finished product.
How Drugs are Protected by Packaging
Proper packaging helps consumers and manufacturers by protecting and accurately labeling the product inside. Regulations surrounding packaging and materials prevent:
- Product mix-ups
- Instability and reduced shelf life
- Product loss
- Contamination via packaging chemicals
- Direct or indirect damage along the supply chain
In addition to the above, product packaging must be tamper-resistant and distinctive by design. Certain drugs require packaging that limits exposure to light or the elements while other drugs are not well-suited for certain packaging materials.
How Chemical Analysis Can Help
Our packaging compatibility services are designed to ensure your product adheres to packaging regulations and remains intact for maximum shelf life. We help by:
- Identifying contaminants. The International Organization for Standardization notes that a finished product can be contaminated due to choice of container or via particulate, chemical or biological substances. We perform in-depth testing to identify potential contaminants.
- Testing for extractables and leachables. When containers contribute to the contamination of drug products, it may be due to the presence of harmful chemicals that leach into the products themselves from packaging. In addition to E&L testing being performed as a requirement for product registration, it is also beneficial when companies choose to change packaging protocols or release product variants that require different, distinct packaging.
- Supporting labeling practices through stability testing. To adhere to Good Manufacturing Practice Regulations, companies must perform stability testing on each product. In addition to meeting the requirement, this process can result in recommendations for improved shelf life and stability which benefits both manufacturers and consumers.
Whether your product is already being packaged or you’re seeking the best possible packaging that will maintain your product’s integrity prior to release, we can help. We’ll test a variety of packaging types and perform detailed analyses to determine how each type affects your product in both the short and long term. The result is a better return on your investment and staying power in the marketplace.
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Request a quote or ask an experienced scientist today.