Primary Packaging Regulatory Approvals

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. Current good manufacturing practice (cGMP) requirements for the control of drug product containers & closures are defined in 21 CFR Part 210 & 211.

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

DMF Guideline For Primary Packaging
Currently The Different Types of DMF Include:
Type II Drug substance, drug substance intermediate & material used in their preparation or drug product
Type III Packaging material
Type IV Excipient, colorant, flavor, essence or material used in their preparation
Type V FDA accepted reference information.

ISO 15378 Regulatory Guideline For Primary Packaging Materials:
Quality assurance: ISO 15378 Primary packaging materials for medicinal products – particular requirements for the application of ISO 9001:2008, with reference to GMP.

USFDA DMF File Submission
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.

Regulatory Approval In India
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals & medical devices.

  1. Regulatory approval in Brazil – ANVISA.

  2. Regulatory approval in the European Union – CE mark.

  3. Regulatory approval in the US.

  4. Quality assurance:
    ISO 9001 , ISO 13485 ,ISO 13587 , 21 CFR Part 820

Related Projects:

ISO 15378 Consultant

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


Name: GMP Guideline
Year: 2003
Type: Got it