Heavy metals (i.e. Arsenic, Lead, Copper and Mercury) present in raw materials and finished products are tested according to the methods as stated in US Pharmacopeia to ensure it is within the specific limit values.
To assess the safety of raw materials and products to ensure the product is safe for release. All tests are carried out according to the methods as stated in US Pharmacopeia.
To ensure the products are manufactured consistently and complying its required specifications. Test analysis includes physical appearance, uniformity of weight, water content, specific gravity, disintegration, tablet hardness and pH.
To provide evidences on how the quality of a product varies with time under the influence of a variety of environmental conditions and to determine the storage condition and establish a shelf life for the product.
Installation, Operational and Performance Qualification are performed for all new equipment used in production to ensure that the equipment can perform effectively and reproducibly based on the approved process method.
Process Validation is performed for each type of dosages (i.e. capsules, tablet, syrup) to ensure the process can produce a product consistently and reproducibly, meeting its predetermined specification and quality attributes.
To ensure the cleaning methods consistently remove all residues to predetermined levels to prevent cross contamination in the next product to be manufactured.