ISO 15378:2017 Packaging in medicinal products

Author: Gerardo Zarate | Multistandard Lead Auditor

The international standard 15378 specifies the requirements to implement ISO 9001:2015 in the design, manufacturing and supplying of primary packaging materials for pharmaceutical products. This includes as the main pillars the following:

• Good Manufacturing Practices (GMP)
  
  
• Risk management
  
  
• Quality control
  
  
• Customer Satisfaction

Coming up next, meet some of the most common examples of drug packaging:

Primary Packaging

1. Ampules: for injectable drugs.

2. Vials: for liquid or injectable drugs.

3. Flasks: for liquid or powder drugs.

4. Pills or Capsules: for orally administrated drugs.

5. Inhaler systems: for pulmonary administrated drugs.

The improvements in pharmaceutical distribution have led to the development of new technologies that ensure drug preservation throughout the whole supply chain, new packaging technologies are shown with the intention of having additional options in their distribution, such as:

• Intelligent materials: which can detect changes in the product or environment.
  
  
• RFID tags: for product tracking and verification.
  
  
• Biodegradable packaging: to reduce environmental impact.
  
  
• Smart close systems: which can detect if the packaging has been previously opened.
  
  
• 3D printing technology: to create personalized and complex packaging.
  
  
  

Benefits of implementing ISO 15378

The implementation of ISO 15378 can offer various benefits, including:

• Quality improvement: by ensuring that the primary packaging materials comply with client and regulatory requirements based on quality standards regarding the risk of each drug.
  
  
• Risk management: by identifying and addressing the risks present in the packaging process, as it is crucial that the drugs comply with the quality and safety they were manufactured for.
  
  
• Customer satisfaction: by providing products that comply with the specific needs and expectations of each market as well as the national and international regulations.
  
  
• Brand protection: by displaying conformity with quality and packaging safety to correctly safeguard pharmaceutical products.
  
  
• Regulatory compliance: by ensuring that compliance with legal requirements and applicable regulations and are kept under regulatory agencies verification.

In essence, the primary packaging of drugs is fundamental to ensure the quality, safety and efficacy of pharmaceutical products, their design and manufacturing must comply with strict quality and regulatory requirements, therefore the importance of considering the implementing ISO 15378 which provides the specifics “shoulds” for an organization to show its clients that the manufacturing of packaging materials for drugs is compliant and adequate for its distribution.