SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS i.e. EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, EMULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS, AND IDENTICAL PRODUCTS).
- The entrance to the area where topical products are manufactured shall be through a suitable airlock. Outside the airlock, insectocutors shall be installed.
- The air to this manufacturing area shall be filtered through at least 20 µ air filters and shall be air-conditioned.
- The area shall be fitted with an exhaust system of suitable capacity to effectively remove vapours, fumes, smoke, or floating dust particles.
- The equipment used shall be designed and maintained to prevent the product from being accidentally contaminated with any foreign matter or lubricant.
- Suitable cleaning equipment and material shall be used in the process of cleaning or drying the process equipment or accessories used.
- Water used in compounding shall be Purified Water IP.
- Powders, whenever used, shall be suitably sieved before use.
- Heating vehicles and a base like petroleum jelly shall be done in a separate mixing area in suitable stainless steel vessels, using steam, gas, electricity, solar energy etc.
- A separate packing section may be provided for primary packaging of the products.
