The diagnostic reagents and kits manufacturers of the country will soon have to comply with a fresh set of Good Manufacturing Practices norms being finalized by the central government. The GMP norms will specify the requirements of premises, plant and equipment for the manufacture of diagnostic kits.

According to Central Drugs Standard Control Organisation (CDSCO) sources, the authority is ready with the draft guideline, which has been circulated among the state drug controllers for their comments. "Once we get the response from the state drug authorities, the GMP for diagnostic kits will be placed before the Drug Technical Advisory Board (DTAB) for ratification. It will then be incorporated in the Schedule M of the Drugs and Cosmetic Rules along with the Medical Devices", they informed.

The licensing authorities are already using this GMP guideline as reference document while clearing the manufacturing license applications, they added.

The CDSCO guideline says that "each licensee shall evolve appropriate methodology, systems and reference; and the manufacturing premises shall be used - exclusively for production of in - vitro diagnostic reagents/kits and or no other manufacturing activity shall be undertaken therein".

The GMP norms will specify the minimum area requirement and minimum equipment needed for an in-vitro diagnostic-manufacturing unit. There are also specific labelling instructions and the entire reagent used in the kit will have to be labelled individually, and a reagent list and their quantities should be disclosed on the container label of the kit. As per the GMP guideline, the shelf life of the diagnostic reagents/kits will have to be fixed by the manufacturer on the basis of the stability studies conducted by them considering all the important protocols of tests of the diagnostic reagents/kits.

The mandatory "general requirements" gives specifications on location and surroundings, buildings and premises, water system, disposal of waste, warehousing area, production area, ancillary area, quality control area, personnel, health-clothing-sanitation of workers, manufacturing operations and controls, raw material inventory, equipment, documentation and records, labels and other printed materials, quality assurance, self inspection and quality audit, quality control system, master formula records, packaging and batch processing records, SOPs and records, reference samples, reprocessing and recoveries, distribution records, validation and process validation, product recalls, complaints and site master files.