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The 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

DMF File Preparation & Submission:

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide classified detailed information about processes, facilities,  or unit used in the manufacturing, packaging, processing, and storing of one or more human drugs.

Beginning on May 5, 2018, new DMFs, as well as all documents submitted to existing DMFs, must be submitted using the Electronic Common Technical Document (eCTD). DMF submissions that are not submitted in eCTD format after this date will be rejected. 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, colourant, flavour, 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.

ISO 15378:2015 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

Application Of ISO 15378

  • ISO 15378:2015 is an application standard for the design, manufacture and supply of primary packaging material for the medicinal product.
  • It is also applicable for certification purposes of primary packaging material for medicinal products in pharmaceuticals and medical device industries. This standard identifies Good manufacturing practice (GMP) principles and Quality management system applicable to primary packaging materials for medicinal products.
  • ISO 15378 can be used for quality improvement, training, auditing and certification.
  •  The standard is reviewed every 5 years.


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.

Related Projects:

ISO 15378 Consultant

Name: Quality Assurance ISO 15378


Name: GMP Guideline