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.

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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