GMP Guideline

Primary packaging material is defined as the material that that may or may not be in direct contact with the dosage form.Primary packaging may comprise any single part of a container closure system including containers, container liners, closures, closure liners, stopper oversells, etc.

A secondary packaging material is a packaging component that is not in direct contact with the dosage form.

GMP Primary Packaging Quality Assurance Services:
Operon Strategist helps manufacturers in determining whether their product is a medical device or a primary packaging material.

Accordingly if the product is a primary packaging material, the client is guided through the DMF compilation & submission process.The manufacturer/supplier (DMF holder) files the DMF to provide information confidentially to US FDA. A DMF is neither approved nor rejected; it is reviewed by FDA when referenced by an applicant in a regulatory submission.

What  is ISO 15378:

ISO 15378:2011 specifies requirements for a quality management system for medical device primary packaging materials and manufacturers of pharmaceutical.

These organizations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products.

The standard delineates GMP principles and specifies QMS requirements applicable to primary packaging materials for medicinal products.

How Can You Prepare ISO 15378:
You can understand the requirements of ISO 15378 by performing a GAP analysis, and implementing QMS and GMP requirements as per ISO 15378.

Related Projects:

GMP-Guideline

Name: GMP Guideline
Year: 2003
Type: Got it

ISO 15378 Consultant

Name: Quality Assurance ISO 15378
Year: 2001
Type: Got it

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