SCHEDULE M – GMP – PART 5 (TOPICAL PRODUCTS)

By / Guidelines / GMP, SCHEDULE M /

GOOD MANUFACTURING PRACTICES FOR TOPICAL PRODUCTS i.e. EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, MULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS AND IDENTICAL PRODUCTS)

SCHEDULE M – GMP – PART 1

The General Requirements as given in SCHEDULE M – GMP – PART 1 of this Schedule relating to requirements of Good Manufacturing Practices for Premises and materials for pharmaceutical products shall be complied for the manufacture of Topical Products i.e. External preparations (Creams, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting powders and identical products used for external applications). In addition to these requirements, the following Specific Requirement shall also be followed.

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS i.e. EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, MULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS AND IDENTICAL PRODUCTS)

The entrance to the area where topical products are manufactured should be through a suitable airlock. Outside the airlock, insectocutors shall be installed.

The air to this manufacturing area shall be filtered through at least 20µ air filters and shall be air-conditioned. The area shall be ventilated.

The area shall be fitted with an exhaust system of suitable capacity to effectively remove vapours, fumes, smoke, 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.

No rags or dusters shall be used in the process of cleaning or drying the process equipment or accessories used.

Water used in compounding shall be Purified Water.

Powders, wherever used, shall be suitably sieved before use.

Heating vehicles and a base like petroleum jelly shall be done in 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.

Reference : Drugs and Cosmetics act 1940