What is GMP standard for pharmaceutical packaging level 1 – ISO 15378?

ISO 15378 certification is one of the mandatory conditions for approval of GMP standards – Good manufacturing practices for pharmaceutical packaging and medical devices.

What is ISO 15378?

ISO 15378 – Good Manufacturing Practices for Pharmaceutical and Medical Device Packaging is an international standard with the current version being ISO 15378:2017. This standard is applied to suppliers of raw materials and materials for the production of level 1 packaging for pharmaceuticals and medical devices such as glass, rubber, plastic, plastic, aluminum foil, film, plywood boxes, etc.

In addition, ISO 15378 certification is also a way for organizations and businesses to confirm that they meet the quality management system (QMS) standards based on the principles of good manufacturing practices (GMP) throughout the design and production process… In other words, ISO 15378 is a combination of ISO 9001 quality management system standards and GMP good manufacturing practices in the pharmaceutical industry or the medical device industry in general.

So is ISO 15378 certification mandatory? According to Official Dispatch 14383/QLD-CL, ISO 15378 certification is one of the mandatory documents required before drug manufacturing and importing establishments submit their applications:

• Register for re-inspection of finished drugs;
• First registration of GMP good manufacturing practices for pharmaceutical packaging;
• Re-register import order (no registration number yet) of finished medicine.

In short, if the facility produces raw materials and packaging materials that come into direct contact with pharmaceutical products and medical devices, it must apply for ISO 15378 certification.

The medical equipment industry is a specialized industry. Therefore, in addition to the requirement to apply ISO 15378 standards, organizations and businesses that want to ensure absolute safety from the production process to packaging and finished products are also required to apply ISO standards such as: 

  ISO 13485: Medical device quality management system;

  ISO 9001: Quality Management System.

ISO 15378 standard structure for primary packaging in pharmaceuticals and medical devices

Packaging of medicines, pharmaceuticals and medical equipment in general is one of the factors that directly affects the quality of medicines and medical equipment. Therefore, the structure of ISO 15378 is quite strict with 10 clauses. In addition, ISO 15378 also includes a number of guidelines to achieve quality management system standards such as:

1. Ensure compliance with legal requirements;
2. Maximum control of risks in the production process;
3. Optimize and use costs effectively;
4. Monitor, troubleshoot and improve systems.

Accordingly, the steps for manufacturing facilities to build and apply ISO 15378 standards include:

• Step 1: Determine the purpose and scope of application of ISO 15378 standard;
• Step 2: Elect representatives and management responsible for implementing and applying the standards;
• Step 3: Develop ISO 15378 standard;
• Step 4: Apply documents and procedures according to ISO 15378 standard;
• Step 5: Conduct periodic internal assessments;
• Step 6: Propose solutions to overcome and improve the production system;
• Step 7: Conduct review and assessment before granting ISO 15378 certification.

Note : 

ISO 15378 certification is valid for 3 years. Organizations and manufacturing facilities need to maintain the standard and conduct ISO 15378 certification reassessment to avoid affecting operations.

 

Benefits of applying QMS packaging level 1 standards for pharmaceuticals & medical devices

In addition to the reason that ISO 15378 certification is a condition for facilities to be allowed to produce pharmaceutical packaging and medical equipment, when applying this standard, production facilities also receive many benefits such as:

➧ Tangible value

1. It is a prerequisite for establishments and organizations to be able to operate in the production of level 1 packaging for pharmaceuticals and medical equipment;
2. Create opportunities for establishments and organizations to expand markets and export abroad;
3. Overall improvement and efficiency enhancement in production processes and systems;
4. Minimize the risks of environmental pollution caused by defective and damaged products;
5. Minimize risks in the production process of pharmaceutical packaging materials and medical devices level 1;
6. Minimize and eliminate cases of packaging materials being mixed with impurities and foreign substances that affect drugs and medical equipment;
7. Affirm that organizations and businesses fully ensure legal requirements throughout the production process.

➧ Intangible value

1. Support marketing and communication campaigns for packaging products of organizations and businesses;
2. Strengthen and build a team of professional staff with high self-awareness and awareness;
3. Affirm to customers and partners that packaging products comply with regulations of the medical device and pharmaceutical industry.

See more:  Procedures for establishing a pharmaceutical company.

Frequently asked questions about standard 15378 – GMP good manufacturing practice

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