ISO 15378 – Primary Packaging Materials for Medicinal Products (GMP)

What is ISO 15378?

ISO 15378:2017 (GMP) is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. ISO 15378 requirements include compliance to ISO 9001 and Good Manufacturing Practice – GMP requirements applicable to primary packaging materials for a quality management system. Where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.

Good Manufacturing Practice – GMP is a term that is renowned worldwide for the control and management of manufacturing, testing and final quality control of food / beverage and pharmaceutical goods and their primary packaging. GMP is a set of rules that gives you the affirmation that your item is safe. GMP is responsible for the safety, efficiency, and quality of pharmaceutical products, cosmetic products and edible products and their primary packaging.

The quality approach of GMP guarantees to enable organizations to limit or eliminate instances of contamination, mistakes, and errors. This thus shields the customer from purchasing an item, which isn’t effective or even dangerous. It is accepted that GMP is one of the best business tools, which will refine both the compliance and performance of the organization.

VIDEO : ISO 15378


Hassle-free ISO 15378 Certification with PQSmitra

ISO 15378 being a specific standard for primary packaging materials for medicinal products, the required controls and monitoring of the quality management system and actual on-floor practices are very specific and stringent. In such a scenario, the practical, easy and effective implementation of the system is very essential. PQSmitra team with expertise of more than 20 years has supported many clients implement GMP – Good Manufacturing Practices and get ISO 15378 certification.

The ISO 15378 implementation process is described below:

Simple & Practical Methodology


Initial Review

  • Review of the existing Quality Management System
  • Gap analysis and planning for the documentation
  • Select a Certification Body of your choice


  • GMP based system designing and documentation
  • Training on GMP and QMS related requirements
  • 100% documentation support

Effective Verification

  • Internal audit for verification of implemented system
  • Management review

Achieve Certification

  • Certification audit –
    Stage 1 & Stage 2
  • Closure of non-conformities support if any
  • Rewarding the certificate to the organization

PQSmitra offers only Genuine Certifications Options.

We ensure that ISO 15378 Certification adds value to your brand rather than distracting from it by getting counterfeit/local certification. Your certificate’s international traceability helps in passing the Certificate Verification process conducted by your overseas customers.

PQSmitra Service Features Appreciated by Clients

PQSmitra’s contribution towards cultural improvement is highly appreciated by Industry & Business Establishment.
This simple & practical solution of performance measurement system has added value towards business excellence.

Simple &
Practical Approach

20+ years of

Successful Projects

Only Genuine

Certification Bodies Associated with PQSmitra

Frequently Asked Questions (FAQ)

  • Integration of customer requirements specific to primary packaging materials for medicinal products
  • Streamlining and Standardizing the manufacturing processes and other business processes
  • Manufacturing Process Control and Monitoring
  • Risk management and Contingency planning
  • Formulating Quality Policy and Objectives
  • Setting up system for documentation and records.
  • Management information system
  • Business performance and sustainability.

The organization shall demonstrate continual improvement in the field of quality management system by maintaining, establishing, implementing and providing documented information.

The documented information required for ISO registration

  1. The organizations scope
  2. The organizations Quality policy and Quality Objectives
  3. A Quality Manual
  4. Standard operating Procedures
  5. Records at individual process / department. E.g. Sales, Purchase, Production, Quality Assurance, Maintenance, Customer Service.

The certification is availed primarily by the companies which are into design, manufacture and supply of primary packaging materials for medicinal products. This ISO 15378 standard can also be used in other industry sectors when a quality management system with additional requirements over an ISO 9001:2015 system is needed.

NOTE : The eligible organizations shall be able to furnish data related to primary packaging materials for medicinal products while certification audit.

  • Entry passport for supply to the customers from pharmaceutical field.
  • Recognition of the certificate and the system by other industry sectors
  • Cost effectiveness at various stages of the operations of the organizations
  • Improved product safety and warranty management
  • Manufacturing process controls enhancing Quality and Productivity
  • Business process streamlining and efficiency improvement
  • Responsibility and Accountability across the organization
  • Better business performance and Enhanced sustainability.
  • Year 2006 – ISO 15378 standard was published
  • Year 2011 – 1st Revision of the standard
  • Year 2015 – 2nd Revision of the standard
  • Year 2017 – 3rd Revision of the standard.
  • ISO 9000:2015 – Quality management – customer satisfaction – Guidelines for complaint handling in organizations
  • ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment.
  • Generally, whenever there is a revision, the previous standard is kept valid for 2 to 3 years. It is also called as transition period. Earlier the organization certified as per previous standards is expected to upgrade and get certified in accordance with revised new standard.
  • This dependence on a number of factors, like the size of your firm, the complexity of your processes, the procedures you already have in place, and so on. Implementation can take 2-3 months for a smaller company (less than 100 people) and 5- 6 months for a larger organization (more than 100 employees). The procedure is also influenced by the amount of time and resources your firm has to devote to implementation. That time should be factored into your overall schedule ahead of time, especially if you have a registration deadline to meet.
  • The ISO certification cost is determined by a variety of criteria, including internal resourcing capabilities, pre-existing management system documentation, as well as the size and scope of products and services offered by the organization. The cost of the Certification Body and the cost of the ISO Consultant are two of the most important charges involved.
  • It takes 15 to 20 days after the 2nd stage of the ISO Audit.
  • An ISO certification will need time, effort, and improvement from a variety of departments inside a company. The steps that must be done, however, are well worth it for any organization. Owners, staff, and customers will all gain from it.
  • To identify the authenticity of your accreditation body, one must
  • Visit the IAF – International Accreditation Forum website home page
  • Go to the IAF – International Accreditation Forum MLA–Multilateral Recognition Arrangement signatory’s category
  • Select the recognized AB – Accreditation Body sub category or recognized region sub category
  • From there you will select your country or the country your accreditation body belongs to
  • After which you can visit the website and look for your certification body.

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