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DMF of pharmaceutical packaging

Jason Dec 13,2018 Share this post:

DMF of pharmaceutical packaging

1.brief introduction

DMF of pharmaceutical packaging belong to the III type DMF register,the plastic paste syringe,plastic vaccine bottle,plastic CRC bottle all can resister the DMF.So if the pharmaceutical packaging manufacturer want to enter to the USA market,it is best to resister a DMF.

2.the purposes of the pharmaceutical packaging DMF

The pharmaceutical packaging DMF has some advantages,I will introduce in the following.

  1. first,simplify the contents of the application of preparations,the pharmaceutical factory can use the DMF number of medical packaging instead of the packaging's detailed information of preparations,so the pharmaceutical manufacturers generally give priority to the drug manufacturers who has the DMF number

  2. the pharmaceutical packaging factory and products which has the DMF number will be publicity on the FDA website,so this factory can be found by many medicine factories,and attract more cooperation opportunities.And the FDA do not charge fees,and can update contents according registered enterprise at any time.

3.contents

the DMF resistered document of pharmaceutical packaging major contains administrative part information,raw material control,process and process control description,applicability information,finished product quality control,aseptic and depyrogenation process validation.

4.process

the DMF of pharmaceutical packaging resistered process and the drug resistered process are same.The documents are printed on american standard paper and bookbinding as required,and submit FDA in duplicate.


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