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September 2023

Educational Presentations & Information

Nitrosamine Impurities in Pharmaceutical Products

What are Nitrosamines?

Nitrosamines are a group of chemical compounds that are formed when a nitrosating agent reacts with an amine. Nitrosating agents are chemicals that contain nitrogen and oxygen in a specific arrangement. Amines are chemicals that contain nitrogen and hydrogen.

Nitrosamines are classified as probable human carcinogens.

To date there are seven nitrosamine impurities that have been identified in pharmaceuticals:

  • N-nitrosodimethylamine (NDMA)
  • N-nitrosodiethylamine (NDEA)
  • N-nitroso-N-methyl-4-aminobutanoic acid (NMBA)
  • N-nitrosoisopropylethylamine (NIPEA)
  • N-nitrosodiisopropylamine (NDIPA)
  • N-nitrosodibutylamine (NDBA)
  • N-nitrosomethylphenylamine (NMPA)

Nitrosamines can be found in the starting materials, be formed during the manufacturing, or packing of pharmaceuticals, or be formed some time after the drug is released into the market.

The risk of nitrosamine formation is higher in certain types of drugs, such as blood pressure medications, heartburn medications, and diabetes medications.

Where can I read about Nitrosamine Impurities?

There is a lot of information on the internet about Nitrosamine impurities

FDA – Information about Nitrosamine Impurities in Medications | FDA

WHO – Information Note Nitrosamine impurities (who.int)

TGA – Nitrosamine impurities in medicines | Therapeutic Goods Administration (TGA)

Medsafe – Medsafe policy for nitrosamine impurities in medicines – information for sponsors

EMA – Nitrosamine impurities | European Medicines Agency (europa.eu)

What do sponsors need to do to about Nitrosamines? 

You need to assess the potential for nitrosamines in the product, as well as the potential for the product to be contaminated with nitrosamines.  The actions you need to take depend on where you are manufacturing and selling the product.

For products manufactured in, or sold into Australia refer to the TGA for more information:  Therapeutic Goods Administration (TGA)

For products manufactured in, or sold into New Zealand refer to Medsafe for more information: Medsafe

 

If you would like some help, or just don’t know where to start we have consultants available to aid with nitrosamine risk assessments.  Click here to fill in a contact form. 

Upcoming Events

Foodtech Packtech and Materials Handling and Logistics Expo

Foodtech Packtech (FTPT) is New Zealand’s largest food manufacturing, packaging and processing technology trade show.  This year they have combined with the Materials Handling & Logistics Expo, and are expecting 250+ local and international exhibiting companies.

19-21 September 2023

News

The news section will be updated as news becomes available.
TGA

01/09/2023

Medicine Shortages – New requirements from this month

There are new reporting requirements for companies supplying medicines into Australia when their medicines are due to go into shortage.

After a six month grace period (from March 2023), Sponsors will be required to report:

  • Changes to the shortage duration or end date and resolution of the shortage.
  • The period of the shortage of the medicine in Australia.
  • Any changes to the period and resolution date of a medicine shortage where the medicine shortage period ends on or after 22 September 2023, regardless of when the shortage was first notified.

11/09/2023

Medical Device Vigilance Program (MDVP) – New Pilot

The TGA is starting a pilot into a new Medical Devices Vigilance Program (MDVP).

The MDVP will be a 12-month pilot, where sponsors can volunteer to participate. 

As per the TGA website the pilot is aimed at supporting medical device sponsors comply with regulations and also to give the public confidence that sponsors are meeting their responsibilities.

Medsafe

01/09/2023

Update to Guidelines on the Regulation of Therapeutic Products

The Guidelines on the Regulations of Therapeutic Goods (Manufacture of Medicines) has been updated to version 5.1.