Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers

Whereas, it is the policy of the State as embodied in Article II. Section 15 of the 1987 Constitution to protect and promote the right to health of the people and instill health consciousness.

Pursuant to Republic Act 971 I, it is the declared policy of the State to adopt, support, establish, institutionalize, improve and maintain structures, processes, mechanisms, and initiatives that are aimed, directed and designed to protect and promote the right to health of the Filipino people.

And pursuant to Republic Act No. 7394, also known as "The Consumer Act of the Philippines", it is the policy of the State to protect the interest of the consumer to promote his general welfare and to establish standards of conduct for business and industry. Towards this end, the State shall implement measures to achieve for the protection against hazards to health and safety and protection against deceptive, unfair and unconscionable sales acts and practices.

Administrative Order 43 series of 1999 was created to institute and uphold the cGMP in the Philippines. As stated in Section 2, Drugs shall be manufactured using methods, facilities and control procedures adequate to preserve their identity, strength, quality and purity. Manufacturers must establish and maintain quality systems to assure that drug products are manufactured, held and distributed in accordance with the cGMP and with the product application or license commitments.

Drug importers shall be responsible in ensuring that the products brought to the Philippines are manufactured in accordance with cGMP.

 

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