What is ISO 15378 Certification?
ISO 15378 is an international standard that specifies requirements for the design, manufacture, and supply of primary packaging materials for medicinal products. It focuses on the management of product quality, hygiene, and risk management processes in the pharmaceutical industry supply chain.
ISO 15378 certification ensures that the pharmaceutical packaging materials are of high quality and comply with international regulations, reducing the risk of product recalls and ensuring patient safety. The standard covers a range of requirements, including good manufacturing practices, quality management systems, and product traceability.
Organizations that obtain ISO 15378 certification demonstrate their commitment to producing high-quality pharmaceutical products, improving customer satisfaction, and complying with industry regulations. The certification can also help organizations to differentiate themselves from competitors and increase their market share.
Achieve ISO 15378 Certification with PQSmitra – A Reliable Partner for Your Pharmaceutical Packaging Quality Management System
At PQSmitra, we provide ISO 15378 Certification services to pharmaceutical packaging material manufacturers. The ISO 15378 standard provides guidelines for the implementation of a Quality Management System (QMS) for the design, development, production, installation, and servicing of primary packaging materials for medicinal products.
By obtaining the ISO 15378 certification, pharmaceutical packaging material manufacturers can demonstrate their commitment to quality and compliance with regulatory requirements. The certification also helps in improving operational efficiency and reducing costs by identifying and eliminating non-conformances in the production process.
Our team of experienced ISO 15378 consultants helps organizations in implementing the standard by providing guidance on documentation, training, and internal auditing. We ensure that the certification process is smooth and hassle-free, and our clients receive their certification in a timely manner.
If you’re a pharmaceutical packaging material manufacturer looking to obtain ISO 15378 certification, contact us today. Our experts will be happy to assist you and guide you through the entire certification process.
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Hassle-free ISO 15378 Certification with PQSmitra
ISO 15378 certification 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 is one of the leading ISO 15378 Certification Consultants in Mumbai, India. Our team with the expertise of more than 20 years has supported many clients to implement GMP – Good Manufacturing Practices and get ISO 15378 certification.
The ISO 15378 certification 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
Documentation
- 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 ISO 15378 Certification Options.
PQSmitra provides legitimate international ISO 15378 certification, avoiding counterfeit or local certifications, and adding value to your brand. Our process includes international traceability and helps you pass Certificate Verification by 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.
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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
- The organizations scope
- The organizations Quality policy and Quality Objectives
- A Quality Manual
- Standard operating Procedures
- 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 certification 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 15378 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 15378 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.