— enforcement action to be taken against defaulters
THE Government Analyst Food and Drug Department is requesting that all manufacturers and repackagers of drugs, cosmetics and medical devices submit their application for licensing of premises, or renewal of licensing of same, before March 31, 2012. Licenses/permits to manufacturers issued in 2011 are invalid for 2012, and it is an offence for manufacturing to be done in unlicensed premises.
Manufacturers are reminded that Regulation 130 of the Food and Drug Regulation, made under the Food and Drug Act, Chapter 34:03 of the Laws of Guyana, stipulates that no regulated articles shall be manufactured in any premises that do not comply with good manufacturing practices, and that the regulated article must be manufactured under the supervision of persons who have had such training as the Analyst Department considers satisfactory, having regard to the duties and responsibilities involved.
Another basic requirement is that the manufacturing premises must be in good repair; defined storage areas for quarantined raw materials and finished products should be provided; the layout and process line should provide a regulated flow to successive stages in the process, to minimize the possibility of cross contamination; an effective sanitation programme should be in place; competent personnel should supervise processing operations; floor level workers should have been exposed to proper execution of their duties and responsibilities; and finished products should be packaged, sealed and labelled in accordance with regulations.
Prospective manufacturers applying for approval to commence operations should also submit the following: a written approval from the Central Housing and Planning Authority (CH&PA); a floor plan of the manufacturer’s premises, and a process flow diagram for each product to be manufactured; written sanitation programme, and schedule and draft of proposed labels.
Existing manufacturers who would like to add new products to their process line should submit a floor plan of the manufacturer’s premises and a draft of their proposed labels.
The Government Analyst Food and Drug Department warns that enforcement actions will be taken against defaulters.