Total Documentation for Good Manufacturing Practice
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GMP, ISO 15378, ISO 44001 Certification Good Manufacturing Practice
GMP Certification
Good Manufacturing Practice - GMP standard recognized worldwide for the control and management of manufacturing, testing and overall quality control of pharmaceutical products. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP Certification confirms the products identity, composition, quality, purity and strength which they represent in the market.
ISO 15378:2012 Certification
The ISO 15378 standard specifies particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) requirements, applicable to primary packaging materials for a quality management system. ISO 15378:2012 Certification demonstrate the ability to provide primary packaging materials for medicinal products that consistently meet customer and regulatory requirements as well as international best practice. ISO 15378:2012 is an application standard that holds good for manufacture, design and supply of the packing material related to the medicinal products.
ISO 44001:2017 Certification
ISO 44001 is an international standard to address collaborative business relationships. It provides a framework to ensure collaborative relationships are effective and optimised. The standard for Collaborative Business Relationship Management System, ISO 44001:2017 certification helps organisations develop and manage business relationships within or between organisations. ISO 44001 presents a real and meaningful opportunity for organizations to both contribute and share best practice methodologies in the areas of collaboration and relationship management.
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GMP documents contain more than 165 editable MS-Word files. These editable documents address all the elements for pharmaceutical manufacturers
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ISO 15378:2017 documents contain more than 150 editable MS-Word files. These editable documents address all the elements of medicinal products packaging material manufacture's certification
