ISO 15378 is a quality
assurance standard for Packaging Material used in Pharmaceutical and
Medical Packaging. It is developed with reference to Good Manufacturing
Practices (GMP).
ISO 15378: 2015
standard specify regulatory requirement, customer requirement, and other
international standards for Primary Packaging Material.
Benefits of ISO 15378 Certification
>> Assures Implementation of GMP
Principals in Manufacturing of Pharmaceutical Packaging Material
>> Eliminates Risk In Manufacturing and adheres to regulatory requirements
>> Assures Pharmaceutical Company of QMS Implementation and regulatory
compliance
>> Competitive Advantage over other Non certified suppliers
>> Symbol of commitment to comply ever changing regulatory requirement
>> Risk Management and Validation
>> Batch Traceability
We at Perfect Pharmaceutical Consultants can help you
>> Implementing ISO 15378 Standard
>> Gap Analysis
>> Getting Certification Ready
>> Closing Audit Non Compliance
>> Designing , Layout, and Documentation- Green Field Projects
>> GMP Compliant Site
Perfect Pharmaceutical
Consultants is a 30 year Old Company having a proven track record and
expertise’s in Pharmaceutical GMP Implementation ( USFDA, EU, WHO, Schedule
M) , we have helped number Pharma Packaging manufacturers with US Drug
Master File ( US DMF), Good Manufacturing Practices ( GMP) and ISO 15378
Certifications.
Reference List Available – Shared on
request only.
Contact Now @ 9890512558 to get your
Plant – ISO 15378 Certified