The vaccine, equivalent to 300,000 doses, manufactured by the Chinese biopharmaceutical company, arrived by the bulk at KL International Airport this morning.

It will be “filled and finished” by Pharmaniaga at its high-tech plant for the National Immunisation Programme, said group managing director Zulkarnain Md Eusope.

“To date, Pharmaniaga has submitted two applications to the NPRA,” he said in a statement. “This consists of product registration for ready to be administered vials and for the fill and finish (F&F) in our EU-certified plant.”

Zulkarnain said process-validated manufacturing and stability study monitoring are critical to complete Pharmaniaga’s application, as well as for quality assurance.

He gave an assurance the vaccine will be filled and finished in full compliance with Good Manufacturing Practice (GMP).

He also said the product validation will start on Monday and is expected to be completed within 12 days.

“NPRA will perform an inspection to verify our plant’s GMP compliance to ensure the vaccines produced are of the quality required for its intended use,” he said.

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