Things To Know About Iso 15378 Primary Packaging Materials For Medicinal Products

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ISO 15378:2011 specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organizations want to prove their capability to constantly meet consumer requirements, with regulatory necessities and ISO 15378 international standards appropriate to primary packaging materials for such medicinal products. The ISO 15378 standard defines Good Manufacturing Practices principles and specifies QMS requirements appropriate to primary packaging materials for medicinal products. The ISO 15378 standard allows obeying legal requirements for pharmaceutical and medical device primary packaging materials. ISO 15378 integrates the requirements of ISO 9001 as well as Good Manufacturing Practices, a regulatory requirement for the pharmaceutical and medical device industries as per all international regulations such as the Code of Federal regulations, European directives, and Indian regulations. Obeying Good Manufacturing Practices principles boosts the competence of production processes. The standard also helps to decrease the risks of safety hazards and product contamination, ...
... and confirm product efficiency and shelf life.
Benefits of ISO 15378:
The ISO 15378:2017 certification delivers a guide to applying risk management and validation in the sector and helps organizations to:
• Confirm compliance with local legal requirements in each country.
• To give assurance to the customers that the production is carried out in agreement with the Good Manufacturing Practices.
• Integrate a pre-existing ISO 9001 certification with a more precise sector certification.
• Confirm obedience to the principles of Goof Manufacturing Practices for primary product packaging of medicines.
• Classify, evaluate, and mitigate or eliminate risks, which are pollution and errors in manufacturing.
• Enhance internal procedures and productivity and profitability of operations.
• Execute processes designed at overseeing the quality management system.
• Adapt a focus on the constant enhancement of processes and quality.
The ISO 15378 accreditation allows a business to promote its products more efficiently. It is even possible that it will assist in effectively entering overseas marketplaces.
How to obtain ISO 15378 Certification?
ISO does not certify 15378, but it does permit an independent certifying body, permitted by ISO, to do so. The ISO 15378 certified auditor training delivers online training and certification to become an internal auditor for ISO 15378:2017 Quality Management System. Having the ISO 9001 certification previously can enable the certification process, which in any case needs the following steps:
• Gaining a copy of the ISO 15378 standard and reading it carefully is the beginning of the road to certification.
• Based on the reading of the text of the ISO 15378 standard, it is desirable to make a checklist of the requirements. It is also exciting to perform a gap analysis to create to what extent the organization presently meets the requirements of the standard.
• As determined by the gap analysis, the essential actions must be executed to achieve compliance with the requirements of ISO 15378.
• In addition, an internal audit must be arranged and carried out to verify full compliance with the ISO 15378 standard.
• In case of finding any type of variation, non-compliance, or nonconformity, the corresponding corrective procedures must be executed.
• Thus, the corrective measures implemented must be followed up to verify their effectiveness.
• Finally, we must choose a certification body recognized by ISO and request an external certification audit.