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.
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube