Post-marketing Control
There are five areas of post-marketing activity, inspection, market surveillance, advertisement inspection, adverse product reaction surveillance, development and strenghtening of manufacturing process.
Inspection
Inspections are performed periodically throughout the year. The activities, including routine inspection and product sampling, are carried out in accordance with the annual plan and in response to complaints or reports of adverse reactions or the results of surveillance. Identified products are tested for fraudulent characteristics. Any product found to be harmful to human health is recalled or confiscated under the authority of the FDA, and will eventually be destroyed in order to ensure that it will not be re-marketed.
Surveillance and Advertisement Inspection
Post – Marketing surveillance is performed all year round and includes the inspection of product labeling and the sampling on of marketed product at the locations under inspection. All printed claims on the labels of cosmetic products must have the supporting evidence readily available.
Advertisements for cosmetics must indicate the product's benefits relating to cosmetic capacity and purposes. Claims that the products have any pharmaceutical characteristics or capability to affect or alter body functions or structure are not permitted; otherwise such products are regarded as drugs to which the Drug Act applies instead of Cosmetic Act. Additionally, no advertisement must claim or suggest that the products have any capability which, in fact, does not exist or that may lead to misunderstanding of their quality.
Cosmetic products with fraudulent claims in labeling or advertising are recalled, investigated, and will be subjected to legal action.
Development and strengthening of manufacturing Process
Manufacturing practice plays a major role in the quality of cosmetic products. Without appropriate guidelines, manufacturers will hardly be able to achieve basic standards and to improve the manufacturing process.
Hence, the objective of this activity is primarily to provide basic procedures for cosmetic manufacturers to develop good practice and to develop the standards of domestic manufacture.
The production of good-quality cosmetics requires close supervision, through monitoring and thorough inspecting at every step of the process. The practices of cosmetic manufacturers are assessed alongside product sampling. Certification of Good Manufacturing Practice is awarded to qualified manufacturers.
The guidelines cover various topics: definitions, personnel, premises, sanitation, equipment, raw materials and packaging materials, production procedures, quality control, documentation, product recall, internal audit, recording of product distribution, complaints, adverse product reaction reporting, and product return.
Manufacturers and the FDA use these guidelines for their operations and inspections to ensure the highest standards of manufactured products.
