Posted On: Oct 26, 2022
THE UNITED REPUBLIC OF TANZANIA
MINISTRY OF HEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
ISO 9001: 2015: CERTIFIED
25th October, 2022
TESTING GLYCERIN AND PROPYLENE GLYCOL FOR CONTAMINATION BEFORE THEIR USE IN THE MANUFACTURE OF PHARMACEUTICAL PRODUCTS
- Following the recent reports by the World Health Organization - Medical Product Alert N°6/2022: Substandard (contaminated) paediatric medicines on potential contamination of unacceptable amounts of diethylene glycol and ethylene glycol in some cough and cold syrups, Tanzania Medicines and Medical Devices Authority (TMDA) would like to remind all applicants and marketing authorization holders to ensure that glycerin and propylene glycol are tested against the known and potential contaminants before their use in the manufacture or preparation of pharmaceutical products as per the current Good Manufacturing Practice (cGMP).
- Diethylene glycol and ethylene glycol are potential contaminants in propylene glycol and glycerine commonly used excipients in cough and cold preparations. Diethylene glycol and ethylene glycol are toxic to humans when consumed and can cause death.
- In view of this, all marketing authorization holders and applicants whose products contain propylene glycol or glycerin are required to test each received container for the presence of diethylene glycol and ethylene glycol. The safe levels should be established based on the officially recognized monograph such as United States Pharmacopeia and British Pharmacopeia.
- For applicants intending to submit new and renewal applications for marketing authorization of the medicines containing glycerin and/or propylene glycol, they should include specifications, analytical testing procedures and certificates of analysis of these excipients in their product dossiers.
- Furthermore, applications for the importation of cough, cold and paracetamol paediatric preparations, with effect from the date of this notice, shall be accompanied by a certificate of analysis indicating that the products have been tested against contamination by Diethylene glycol and ethylene glycol and any other potential contaminants.
- We anticipate your cooperation in this matter.
Tanzania Medicines and Medical Devices Authority (TMDA),
Plot No. 56/1, Swaswa Road, Opposite Martin Luther High School,
P. O. Box 1253, Dodoma.
Tell: +255 22 2452108/2450512/2450751
Toll-Free No: 0800110084