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ISO 15378 - Primary Packaging Systems for pharma industries

Quality assurance: ISO 15378 Primary packaging materials for medicinal products – particular requirements for the application of ISO 9001:2008, with reference to GMP.ISO 15378 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 meets customer requirements, including regulatory requirements & international standards applicable to primary packaging materials.

Operon Strategist helps manufacturers develop their quality management system as per the requirements of ISO 15378. We help in documentation, training & implementation of the quality system. We also conduct mock internal quality audits to help clients familiarize with the audit process. We guide the client through the audit process & subsequently also help them close any non-conformances observed during the audit.

Please feel free to email us on info@qecs.co.in / pranav.shah@qecs.co.in to get full client list.

5 Step to Certification... Think a big…

Gap Analysis

visits your Organization to review and document your current processes and procedures, highlighting the areas that do not meet the requirements of the Standard, legalization and business needs.

Development of System

we develop the management systems based on the customize requirements and based on the standard’s requirements. We have competent and professional team, they will guide and develop the systems with latest guideline and suggest perfect solutions which added values in your Policies, Objectives, Business needs and Processes.

Implementation

Now it's time to make sure any required process or procedural changes are made, as highlighted in the review by competent and professional team. QECS can provide templates to assist you in doing this.

Monitoring

QECS qualified team monitored the developed and implemented systems based on the requirements define in standards, in professional manner same as per the third-party certification audit, once we are satisfied with the systems will be recommended for the certification audit.

Certification

An Auditor must now visit your Organization to check that the documented processes are being followed and that the necessary changes have been made. Once they are satisfied, you will be awarded your certification.


Please feel free to email us on info@qecs.co.in / pranav.shah@qecs.co.in to get full client list.

Please feel free to email us on info@qecs.co.in / pranav.shah@qecs.co.in to get full client list.

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