ISO 15378 is the quality management system for primary packaging. Get ISO 15378 certification

1. ISO 15378
Certification
Primary Packaging
https://www.operonstrategist.com/iso-15378-quality-assurance/

2. ISO 15378 Certification is quality assurance for primary
packaging materials for medicinal products particular
requirements for the application of ISO 9001:2008, with
reference to GMP.

3. What is ISO 15378 Certification?
 ISO 15378:2017 standard specifies requirements 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 applicable to
primary packaging medicinal materials.

4.  Aims to enhance customer satisfaction through the
effective application of the system, including processes
for improvement of the system and the assurance of
conformity to customer and applicable statutory and
regulatory requirements.
 The primary packaging material is defined as the material
that that is in direct contact with the dosage form.
Primary packaging may comprise any single part of a
container closure system including containers, container
liners, closures, closure liners, stopper oversells, etc.

5. ISO 15378 Benefits
 ISO 15378 Standard have strategic tools that reduce costs
by minimizing waste and manufacturing errors and
increasing productivity.
 It helps companies to access new markets and facilitate
free and fair global trade.
 The manufacturer can boost their efficiency of production
processes by adhering GMP principles as per ISO 15378
standard.

6.  To mitigate your risks especially related to product
contamination, mix-ups and errors and ensure product
efficacy and shelf life.
 Assurance of quality products to your clients. Enhance
customer satisfaction.
 Competitive Advantage over other non-certified suppliers.
 Application of risk management helps to reduce errors
associated with the product.

7. Application of ISO 15378
 ISO 15378:2017 is an application standard for the design,
manufacture and supply of primary packaging material for
the medicinal product.
 It is also applicable for certification purposes of primary
packaging material for medicinal products in
pharmaceuticals and medical device industries. This
standard identifies Good manufacturing practice (GMP)
principles and Quality Management System applicable to
primary packaging materials for medicinal products.

8.  ISO 15378 can be used for quality improvement, training,
auditing and certification.
 The ISO 15378 standard is reviewed every 5 years.

9. We are assisting with the manufacturers of Primary
packaging material to understand the requirements of ISO
15378 by performing a GAP analysis, and implementing
QMS and GMP requirements as per ISO 15378:2017.
We support the manufacturers of primary packaging
materials for the medicinal product to enhance their QMS
system by addressing specific requirements to meet the
quality objectives as per ISO 15378 certification. We assist
the pharmaceutical and medical device industries to assess
their suppliers of primary packaging materials and increase
overall product quality.

10. Thank You.
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