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.