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 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. Primary packaging regulatory approval Services In  Australia, Brazil, Bangladesh, Comoros, Costa Rica, Canada, Central Asia, Colombia, Egypt, Iceland, India, Indonesia, Nigeria, New Zealand, Oman, Peru, Qatar, Israel, European Union, Europe & Middle East, Hong Kong, Kenya, Korea, Kuwait, Liberia, Malaysia, Mexico, Mauritius, Saudi Arabia, Singapore, South & Central Asia, South Africa, Southeast Asia & Pacific, Sri Lanka, Switzerland, Russia, Singapore, Turkey, Thailand, Ukraine, United Arab Emirates.

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 use to provide classify detail 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 submit using the Electronic Common Technical Document (eCTD). DMF submissions that are not submitting in eCTD format after this date will reject.

Currently The Different Types of DMF Include:

  • Type II Drug substance, drug substance intermediate & material used in their preparation or drug product.
  • The Type III Packaging material.
  • Type IV Excipient, colourant, 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.

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 use for quality improvement, training, auditing and certification.
  •  The standard is a review every 5 years.

USFDA DMF File Submission
Accordingly i,f 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 approves nor reject; it is review by FDA when referenced by an applicant in a regulatory submission.

Related Projects:

ISO 15378 Consultant