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Equipment

List of major production and quality control equipment is provided in Appendix 8.

Cleaning and Sanitation

Except some automatic and semi automatic cleaning procedures for few types of equipment in production unit all cleaning and sanitation are performed manually. All cleaning activities are performed according to written procedures by trained operators. For removing and neutralizing high potent material approved cleaning agents are used and the cleaning validation has approved their effectiveness for remove the material. For sanitation the water distribution there are program and records are archived in technical office.

GMP critical computerized systems

Material handling in the warehouse, production and QC (Raw material, packaging material, laboratory material and finished product) as well as quarantine and control bill of material are controlled by an ERP software (Namaad Iran®).

Environmental monitoring system is controlled mostly by Honeywell® software. This system monitors the temperature, humidity, air pressure of the clean rooms and any deviation from the pre established parameters will be noted in the system.