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Facility Inspection

Inspection and licensing of pharmaceutical manufacturing facilities on the basis of compliance with GMP are a vital element of drug control. Buliom supports WHO initiatives aimed at improving inspection techniques and increasing the frequency of inspections for the common good of society. Besides the internal and third-party inspections we frequently conduct for quality assurance purposes, we routinely host government inspectors from abroad to gain their approval when preparing to enter new markets.
Government inspectors represent the enforcement arm of a national drug regulatory authority. Its function is to ensure adherence by manufacturers to all licensing provisions and specifically to GMP. The objectives are to provide authorization for the importation of the manufacturer’s products into the country of the inspectors. The first objective involves a sequential examination of production and control activities on the basis of GMP guidelines issued by the WHO or of nationally determined requirements. The second requires verification that production and quality control procedures employed in the manufacture of specific products are performed correctly and that they accord with data supplied in the relevant licensing applications. Inspection is also depending on other factors, such as the national legislation and regulations of the inspector’s country and/or resources available.
While the inspection criteria and procedures vary from country to country, their results do not. Buliom products have successfully been approved by health ministries and agencies from Australia to Africa, the Middle East to Asia. We realize that the future of our company depends on our continued product improvement and market expansion. Facility inspections are a top priority for us and their results reflect our policy of constant improvement and meticulous attention to detail.

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