Regulatory Challenges in Pharmaceutical Packaging and How to Address Them

Posted on 
December 29, 2020
Laura Foti
CMO, Specright

The pharmaceutical industry doesn’t allow room for error. This is the case not just for product quality, but also how products are packaged and labeled. Packaging is highly regulated around the world to ensure products are safe from contamination and tampering, as well as to ensure critical information related to dosage, usage, manufacturing, expirations, and more are correctly displayed.

Creating solutions that address all of the above is nothing short of complex. There are means to simplify parts of the process, however. Specifically, a few of the challenges with package design and implementation can be addressed with specification management software. Here’s what you need to know.

Guidelines for Pharmaceutical Packaging and Labeling

Pharmaceutical packaging and labeling are crucial in maintaining pharmaceutical products' safety, efficacy, and compliance. In an industry where patient safety is paramount, it is critical to follow detailed criteria that control the packaging and labeling operation. To protect public health, the pharmaceutical sector follows stringent rules. Adherence to regulatory rules is non-negotiable when it comes to packaging and labeling. Compliance with the regulations issued by the Food and Drug Administration (FDA) in the United States and equivalent organizations around the world is important. You must be up-to-date on the newest regulatory requirements to ensure your packaging and labeling are up to par.

Pharmaceutical items require precise and detailed labeling; product names, dosage directions, active components, precautions to take, expiration dates, and batch numbers should all be included on labels. The text should be legible in terms of font size and clarity. Instructions should also be clear and concise to help improve patient compliance and safety. 

Packaging Design plays an important role in the pharma world and also in maintaining the integrity and safety of the pharmaceutical product - and it is a must to safeguard the medicine against physical, chemical, and biological threats. For example, blister packs make sure that the product doesn’t get damaged during transit until it reaches the end user. The right material should be considered for drug packaging to ensure the product is sealed correctly and prevent contamination during storage, handling, or transit. The CFR - Code of Federal Regulation also has regulations about tamper-evident packaging requirements for over-the-counter (OTC) human drug products. Another factor to note is that regular testing and validation of the packaging material is important to preserve its quality. 

Primary and Secondary Pharma Packaging Design Guidelines

Any packaging that comes into direct contact with a pharmaceutical, such as a blister pack or a prefilled syringe, is considered primary packaging. Secondary packaging is defined as anything that does not come into direct touch with a product, such as a box or an accessory, such as a syringe plunger rod. As per the FDA, all primary and secondary packing materials must be acceptable for their intended application. And 'Suitable for intended use' means that the packaging should not only protect the product's dosage form but also be compatible with it. Packaging for pharmaceuticals has to conform to pharmacopeia standards.

Another requirement pharmaceutical manufacturers should remember is that the primary and secondary packaging should be composed of a material that is considered safe to use, both with the product's administration technique and the dosage form. Keeping that in mind, the primary packaging should protect the products from degradation and subsequent loss of efficacy due to oxidation, microbial contamination, or exposure to light. The primary packaging should also not interact with the product in any way that would alter its properties or even release any substance that is carcinogenic or mutagenic into the product. 

On the other hand, secondary packaging should fulfill at least one of these conditions: It should offer protection against light and excessive reactive gas emissions in or out of the packaging system. Also, protect packaging systems that require additional handling protection or are flexible. Keep it protected from microbes and also prevent any moisture or solvent transmission from inside or out of the packaging system and affect its shelf life.

1. Anti-Tampering Requirements

The infamous Tylenol tragedy led to a complete overhaul in pharmaceutical packaging. Now, all manufacturers are required to create tamper-proof packaging, usually with a minimum of two layers of protection. These may include features like blister packaging, shrink wrap, HIS liners, or tape seals, to name a few. These requirements aren’t new, but they remain just as much of a priority today as they did when they were introduced. With rising shipping and production costs, many manufacturers are re-evaluating how they can create more efficient, less wasteful packaging that meets anti-tampering standards.

Specification management software puts packaging challenges into perspective for pharmaceutical companies. Tracking costs at the spec level, as well as understanding the packaging’s impact on sustainability, can help companies make impactful decisions that also comply with anti-tampering requirements.  

2. Multi-Layered Labeling Regulations

Labels for pharmaceutical products require a multitude of important information, including:

Product name:

For unambiguous identification, the healthcare or pharmaceutical product name should be prominently printed on the packaging. The product name should be brief, easy to remember, and reflect the medication's intended usage or purpose. The packaging of pharmaceutical products should be in adherence to FDA regulations for packaging requirements and done in such a way that will help the consumers identify and select the right medications for their requirements.


When it comes to labeling the ingredients of pharmaceutical products, transparency is important. The ingredients should be clearly described on the label, allowing people to decide on the medications they are to use. To make sure that the information is easy to understand, it is important to conform to FDA guidelines for labelling requirements for font size, legibility, and proper terminology. 

Intended use:

The pharmaceutical product's intended purpose should be clearly displayed on its label, especially if it is an over-the-counter drug. This description gives very important information about the medication's precise function, assisting consumers in understanding how it can benefit them. Pharmaceutical businesses must correctly and very simply define the intended usage under the FDA standards making it easily understandable for individuals seeking the right drug product or OTC drugs for their health issues. 

Storage instructions:

Proper storage of the drugs is important for preserving their efficacy and safety. The label should include clean and concise storage instructions indicating the best conditions for storing the medication or medicinal products. These directions may also include particulars about the storage conditions like temperature requirements and the importance of avoiding exposure to light or moisture.

Expiration date:

As with everything else, every medicine has a shelf life after which its safety and effectiveness are no longer guaranteed. The expiration date should be prominently printed on the label on any type of packaging to notify customers about the date until it is viable. Pharmaceutical businesses should adhere to FDA requirements by precisely determining the expiration date through stability testing and clearly communicating it on the label. 

Drugs facts table:

This is an integral part of a pharmaceutical label since it contains important information regarding the medication's active ingredients, its uses, cautions, directions, and what could compromise its sterility. This information must be displayed in a standardized way for the consumer to access quickly and understand the relevant information before using the medication.

Dosage instructions:

Dosage instructions should also be prominently displayed on the label to ensure proper medicine delivery. To avoid any mix-up, clear and straightforward directions will help the consumer understand how much and frequently the medication should be taken. This also holds true for medical devices. Clear instructions should be provided on its usage. 

Warnings or side effects:

Medicinal products should include warnings or side effects that the consumer should be aware of. This information, like everything else be clearly and prominently displayed on the label so that the individual can make informed decisions about the medicine's use. It will also help the users to seek the proper medical help if required. 

Allergy information:

The information on each label will vary by the product, but it’s easy to see just how detailed and specific a single pharmaceutical product can be. What’s more, different products have different requirements when it comes to formatting. There’s also the matter of choosing label materials that meet regulations. Many manufacturers choose a multi-layer label printed on plain white paper because it allows them to print large amounts of information. You must also take care to choose labels or “low migration” inks or adhesives that will not come into contact with the product. Managing all of these details is easier with specification management software. Companies can track unique data for every product and material to ensure proper labeling and potentially avoid costly recalls due to missing or incorrect label information.

3. Pharmacopeia Standards for a Global Market

The World Health Organization has established pharmacopeia standards for the global pharmaceutical market. In addition to these standards, manufacturers must also consider that individual countries and regions are allowed to modify these standards to satisfy unique needs (the European Pharmacopeia is an example of this). This creates a unique set of challenges for manufacturers who serve customers across borders as one pharmaceutical product may require multiple labels or types of packaging, depending on its destination country. Specification management software unites these various fragments into a centralized knowledge base. Knowing each country’s unique requirements with confidence makes it easy to do business across borders. Manufacturers can also use their spec management platform to improve supplier connectivity and collaboration and strengthen the pharmaceutical supply chain as a whole.

How to Address Regulatory Challenges with Packaging Specification Management Software

The myriad of moving parts to pharmaceutical regulations for packaging requires organization and attention to detail, both of which are supported with packaging specification management software. By managing package design requirements at the spec level, manufacturers can acknowledge the unique requirements for every product. What’s more, as industry regulations evolve, specs can be updated in real-time so designers can trust that they’re always designing for the most recent update and remain compliant.

Watch our webinar to learn more about how Specright brings clarity to packaging regulations for high risk goods with specification management software.


Laura Foti

Laura leads marketing and investor relations at Specright. Prior to Specright, she led advertising and analytics at GE Digital, GE’s Industrial Internet software business. Before that, she was a consultant at Deloitte Digital working in enterprise digital transformation, where she helped clients design and deploy eCommerce experiences, develop revenue-driving mobile apps, and reimagine their global digital marketing strategy. Laura was named to the Forbes 30 Under 30 list for marketing and advertising and Brand Innovators 40 Under 40 and 100 Women to Watch lists. She graduated from the S.I. Newhouse School of Public Communications at Syracuse University. She resides in Newport Beach, CA.

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