OBJECTIVES - Food and Drug Administration

OBJECTIVES

To provide stakeholders engaged in the manufacturing processes for ENDS/ENNDS products a general overview of FDA's regulation for manufacturers and traders

To ensure that all concerned stakeholders understand the process for the application of a license to operate and the regulatory requirements during operations

MANUFACTURER

means an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution. A trader shall be categorized a manufacturer.

TRADER

means any establishment which is a registered owner of a health product and procures the raw materials and packing components and provides the production monographs, quality control standards and procedures, but subcontract the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in the distribution and/or marketing of its products.

Manufacturing Process

Formulation

Delivery / Distribution

Procurement and

preparation of raw materials

Manufacturer

Storage / Warehousing

Testing and Inspection

Production Process

The same process can apply for traders, with the exemption of the production process that is subcontracted to a manufacturer.

The coverage of the contract between a trader and a manufacturer vary, depending on the agreement between the two establishments.

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download