Pharmaceutical Packaging & Regulatory Compliance: Meeting FDA & EU Pharma Standards
The need for regulatory compliance in the health and pharmaceutical industry is not limited to drugs, patents, and processes. The Food & Drug Authority (FDA) (USA) and the EU Good Manufacturing Practices (GMP) have set strict packaging and labeling requirements for anything that is ingested, eaten, or applied to the human body, including food, drugs, and cosmetics.
Most of those requirements are applicable to the primary packaging components such as medicine bottles, vials, or blisters) but the regulation regarding the secondary components, such as the cardboard boxes can also not be ignored.
The article comprehensively brings together the FDA and EU GMP requirements pertaining to the secondary packaging components of the health & pharma industry. FDA and EU are two of the most diligent and trusted authorities when it comes to policy guidance. Reviewing their guidelines on secondary pharmaceutical packaging allows readers to understand and comply with the regulations more effectively.
Functions of Pharmaceutical Packaging
According to a Technical Report Issued by the World Health Organization (2002), packaging serves the following functions:
- Containment of the product
- Protection against all adverse environmental influences that may affect its quality or potency
- Presentation and Information about the medicinal product.
- Detection of Counterfeiting
- Package Inserts for Patients
Let’s briefly highlight each of these functions.
Containment: The first and foremost function of pharmaceutical packaging is to contain the product. Specifically in the case of secondary packaging, the medicine boxes should be strong enough to hold the contents in case of normal handling. Cardboard boxes that rip or cut easily, for example, not only negatively affect the medicinal count per box but also present a dangerous possibility of being misused.
Protection: Similarly, cardboard boxes that are manufactured using low-quality paper are also unable to meet the second function of packaging i.e., protection from environmental influences. This is especially true for medicinal products that are sensitive to light and moisture. Medicine boxes are often found in glossy packaging and top lamination. This provides a degree of insulation against light and heat under normal environmental conditions (harsher conditions may require the medicines to be stored in refrigerators, for example).
Presentation and Information: Pharmaceutical packaging is also a vital source of information on medicinal products. Bottled medicines or pressurized containers have the advantage of sticker labels being pasted directly onto the surface of the primary packaging. However, this is not the case for blisters, vials, or ampules which either do not have enough surface area for printed information or the information is likely to be disrupted with use. Secondary packaging in the form of cardboard boxes, packaging inserts, or special labels acts as carriers of essential information.
Counterfeit Detection: The WHO along with other reporters, has produced several documents on the incidence of falsely labeled, counterfeited, smuggled, or substandard pharmaceutical products. Not only are such preparations illegal, but they can prove to be extremely dangerous in case of human consumption. Individual patients are neither suspecting nor resourceful enough to get every single package checked before consumption. As a result, the task of integrating counterfeit detection becomes an important function of pharmaceutical packaging. Tamper-proofing or including originality indicators on secondary packaging enables especially OTC medicine consumers to visually examine the product and detect any counterfeiting or tampering before use.
Inserts for Patients: Packaging can also serve as an added convenience for the patients. For example, a checklist of daily doses, and a leaflet diary to record any side effects all add to the help that the medicine intends to provide to the patient.
After understanding the function of secondary pharmaceutical packaging, we’re going to list the key FDA and EU GMP requirements:
Secondary Pharmaceutical Packaging Regulations by the FDA
| Material | All packaging is mandated to ensure proper handling, contamination control and clear batch identification. |
| Labeling | According to 21 CFR Part 201, the secondary packaging must not be false, confusing, or misleading. Labeling must include all essential drug information, including: – Dosage – Route of administration – Warnings – Storage Instructions |
| Serialization | All products must comply with the Drug Supply Chain Security Act (DSCSA) for serialization and tracking, which requires Unique Identifiers (UI) which can include barcodes, QR codes, or RFID tags on all secondary packaging. |
| Track-and-Trace | All secondary packaging must enable the track-and-trace process in order to prevent counterfeit |
| Tamper Resistant | 21 CFR 211.132 requires all OTC medications to have Tamper-Evident Packaging. Additionally, the Poison Prevention Packaging Act (PPPA) requires certain medications to have child-resistant secondary packaging. |
| Storage and Stability Information | All secondary packaging is mandated to include storage instructions, temperature guidelines and shelf-life information. Additionally, some products are required to have an extra layer of protective packaging e.g., moisture-resistant or light-blocking add-ons. |
| Country-Specific Regulations | FDA directs that local drug policies also have to be followed for international sales. All text needs to be in the local language(s). |
Secondary Pharmaceutical Packaging Regulations by the EU
| Material | Materials such as PVC need to be restricted. Secondary packaging needs to be compliant with EU Packaging Waste Directive 94/62/EC to ensure environmental sustainability. New EU requirements have mandated that secondary packaging must be scaled down to its minimum size with a maximum of 40% empty space allowed against the total volume of the packaging. |
| Labeling | Direction 2001/83/EC requires labeling to be in the official language (s) of the country of sale and must include the following information: – Product name, active ingredients, strength – Dosage instruction – Route of administration – Storage conditions – Expiry Date – Warnings and Legal Classifications (e.g., prescription-only or OTC) By January 1, 2028, all secondary pharmaceutical packaging would need to include sorting and reusability symbols and QR code. |
| Serialization | Directive FMD 2011/62/EU requires a Unique Identifier (UI) on all products which is a 2D Data Matric Code with product code, batch number, serial number, and expiry date. |
| Track-and-Trace | All serialization must be uploaded to the EU Medicines Verification System (EMVS) also known as the EU Hub. |
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Tamper Resistant | Directive FMD 2011/62/EU also directs secondary packaging to have a visible seal that provides tamper evidence. Further tamper-evident and child-resistance features are required for specific medications under the EU Medicinal Product Directive as well as ISO 8317. |
Storage and Stability Information | EU Directive 2001/83/EC outlines the storage conditions for storage and stability of the medicine. For example, temperature-sensitive drugs need to be protected through foil-lined boxes or additional laminations. |
Country-Specific Regulations | All text information including that on leaflets and that printed on the boxes needs to be in the local language(s). Especially in EU countries, Braille Labeling is mandated for blind or partially sighted customers. |
Key Issues that Can Arise with Substandard Pharmaceutical Packaging
The 21 CFR 7 gives the FDA the authority to recall a drug either voluntarily or by requesting the manufacturer or distributor. One of the factors leading to such a recall is “Incorrect Packaging, Storage or Labelling”. Labels conveying incorrect information to patients or ineffective storage can risk human lives and adversely affect the viability of the concerned pharmaceutical company. A single recall, especially for OTC drugs, can also diminish consumer trust in other products by the same brand. In such cases, consumers are deprived of medicinal products that can potentially help them, and the pharmaceutical companies are deprived of the return on their investment. All of this can be avoided through secondary pharmaceutical packaging that is high-quality and compliant.
How to Achieve High-Quality & Compliant Pharmaceutical Packaging
As seen from the information above, even secondary pharmaceutical packaging needs to be compliant with the FDA, EU, and local regulations. Such regulations not only protect human life but also ensure that drug companies are able to operate without recalls, loss of goodwill, and business losses.
In order to achieve such compliant and high-quality packaging, the most important aspect is to partner only with the best custom packaging manufacturer. A team that not only understands the compliance issues but is also able to provide the best quality packaging for your products.
Especially for OTC medications, custom packaging design such as graphics, information, and even the look and feel of the boxes are extremely important. The market is competitive and, many times, custom packaging is the only way to attract customers to switch from an existing product to a new and better one.
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Ayesha Khubaib
Ayesha has a diverse experience in areas of marketing and management. Over the years, Ayesha has been involved in the packaging sector in various capacities and now aims to share packaging market insights with her readers
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