Qualityze Logo
All Posts

A Brief Look Through the Packaging and Labelling Guidelines for Pharmaceuticals

01 Aug 2023

Adhering to quality standards implies much more than maintaining the consistency of the product quality especially for the pharmaceutical manufacturers. They should consider other aspects as well including the packaging and labelling guidelines that the FDA has released to ensure that all the medical supplies reach safely to the patients. 

The quality management system for pharmaceutical manufacturers should be powerful enough to manage all the aspects of the quality of medicines as well as their packaging and labelling information. 

Why you should follow Packaging and Labelling guidelines for Pharmaceuticals? 

The quality guidelines for packaging and labelling is important to ensure that; 

  1. All the medicines are protected from the external influences that can affect its curing capabilities and may have an adverse impact on the patient’s health. 
  2. All the medicines are protected against all sorts of contamination.
  3. All the medicines are protected against any physical harm including leakage and breakage. 
  4. All the medicines carry the appropriate labels for dosage, use, and identification. 
  5. All the medicines are kept safe with particular packaging material. 

The most commonly used article to store the pharmaceuticals products safely is the container. The closure also plays an important role. It should not interact chemically or physically with the contents of the container, altering their quality. There are generally four kinds of containers preferable for the pharmaceutical industry: 

  1. Closed Containers 
  2. Bottles 
  3. Droppers
  4. Remedy Kits
  5. Ampoule/Vial

In addition to the medicines, the machines and medical equipment require a special type of packaging and labeling facility to ensure appropriate usage of medical supplies for quality care of patients. 

Let’s have a quick look at the proper labeling guidelines for the pharmaceutical and healthcare industry compiled from credible resources. 

1. Labelling Care 

As per the guidelines shared by FDA, all the labels to be used in the pharmaceuticals and healthcare industry should be designed and applied well so that they stick to a place without losing the legibility in the varying environments including storage, regular use, and distribution. 

It is the responsibility of the label manufacturer to ensure that the legibility of the print remains unaffected through the product life cycle. They should follow the compliance requirements for content as well as format. 

2. Show Product Information 

Every pharmaceutical product requires some specific kind of information to be displayed on the product including the product name, ingredients, the facts table, warnings, directions of use, and the allergic reactions that it can cause. 

Displaying the product information is one of the compliance requirements to be fulfilled by the pharmaceutical manufacturers to avoid any harmful reactions to the user or patients. 

3. Maintaining Label Format (For FDA) 

As we already discussed that FDA has specified an appropriate format for different pharmaceutical products including combination products, contraceptives, and other critical medicines. Some of the guidelines are –  

  1. You must use legible font size and type 
  2. You must use the language that’s easy-to-understand. 
  3. You must take care of format especially for important information like warnings.
  4. You must describe the materials if it contains products with a dropper or other types of container.

4. Selection of Right Materials 

Labelling materials are not strictly monitored in the pharmaceutical and healthcare products. You can use standard white paper to multi-layer labels based on the purpose you want the label to serve. 

Considering the safety, you can be selective with the adhesives for the labels to avoid any other substance transfer to the medicines or devices. 

5. Controlling and Inspecting Labels 

In addition to the legibility, you must ensure that the information printed on the label is correct and consistent to comply with the industry standards. it ensures safety and liability too. You must discuss the same with the label manufacturer to keep quality processes in control. 

However, you can use a supplier quality management software to ensure that you are getting only quality components from approved suppliers 

Functions to be served by Packaging 

There are four core functions to be served by packaging including: 

1. Containment 

It is one of the most basic functions that packaging serves for the medicinal products. You must consider the high-quality packaging to ensure zero product harm in manufacturing as well as the distribution system. The packaging material you use must not; 

  1. Leak, diffuse, or permeate.  
  2. Be weak to keep the contents safe when it comes to normal handling.
  3. Change the properties of the medicine till the time of dosage.

2. Protection 

It is quite an important aspect to be considered when it comes to packaging the medicinal products. The packaging material must protect the main product from the influence of external factors such as sunlight, oxygen, moisture, contamination, or any physical damage. 

The packaging material you use must be compatible with the pharmaceutical ingredients used in manufacturing the product. Hence, protecting the product and their integrity is one of the key functions that packaging must serve. 

3. Stability  

Guidelines on the stability of the pharmaceutical products is specified. Stability and compatibility generally fall in the initial level of research and development. The selection of the packaging material should be done after careful evaluation of possible interactions between the material and the content of the container. 

The stability of the product matters to ensure that none of its properties change when it comes in contact with the packaging material. It may have a serious impact on the quality of the product. 

4. Storage 

The storage guidelines for the pharmaceutical goods are specified in the GMP guidelines to ensure safe storage for the specified time and temperature limit. For example – the normal instructions of storage that you will read on a medicinal product or drug is – “Store in a Dry and Cool Place” or “Don’t keep under direct sunlight” etc.  

Again, it is not just about storage; it is about safe storage. Make sure the packaging material you use is effective enough for safe storage. Even if there are the certain specifications, share them clearly and concisely. 

To ensure that all the packaging and labelling guidelines are properly used, you must establish a closed-loop quality management system that can help your teams to keep control of product and process quality while mitigating operational risks. It will help drive a culture of continuous improvement too. 

One of the finest ways to ensure the compliant quality system is implementing the Qualityze EQMS suite. Built on the most powerful and secure cloud platform i.e. Salesforce, it offers great flexibility, scalability, and reliability to manage processes flawlessly even if you have geographically dispersed teams. 

Let your pharmaceutical product quality control be managed through a powerful quality management system



Request Demo

© 2024 Qualityze | All rights reserved. | Privacy Policy