The Government Analyst Food and Drug Department is advising all manufacturers and repackagers of drugs, cosmetics and medical devices to submit applications to renew their licenses before Saturday.
In a press release, the Department cautions manufactures that licences issued in 2011 are no longer valid and it is an offence to manufacture in an unlicensed premises.
It noted too that stern action will be taken against defaulters.
According to Regulation 130 of the Food and Drug Regulation made under the Food and Drug Act, “no regulated articles shall be manufactured in any premises unless there is a licence to indicate that the conditions and facilities at the premises comply with Good Manufac-turing Practices and that the drug is manufactured under the supervision of persons who have had such training as the department considers satisfactory having regard to the duties and responsibilities involved.” Licences would only be issued to premises that meet the good practices guide set out.
The basic requirements for licensing are: that the premises must be in good repair; defined storage areas for quarantined raw materials and finished products should be provided; and the layout and process line should provide a regulated flow to successive stages in the process to minimise the possibility of cross contamination.
An effective sanitation programme should also be in place; competent personnel should supervise processing operations; floor level workers should have been exposed to the basic training to provide the necessary information for the proper execution of the duties and responsibilities; and finished products should be packaged, sealed and labelled in accordance with the regulations.
Prospective manufactures applying for licences should also submit written approval from the Central Housing and Planning Authority; a floor plan of the manufacturing premises; a process flow diagram for each product to be manufactured; written sanitation programme and schedule; and drafts of proposed labels.
Licensed manufactures who would like to add new products to their process line should comply with the last three requirements list.
