The audit is an important element in deciding the development and market presence of any organization, mainly in the pharmaceutical Feild. The success of an audit leans on numerous factors, some of the Audit Check List for the Engineering Department are described below:
1.0 Audit Check List for Engineering Related to Support System
1.1 HVAC SYSTEM
1.1.1 Are pre-filters present in heating, ventilation, and air-conditioning (HVAC) systems and replaced on a routine basis?
1.1.2 Are high-efficiency participant air (HEPA) filters tested for integrity, at least annually?
1.1.3 Are HEPA filters terminally located?
1.1.4 Are ductwork materials impervious to disinfectants that may cause corrosion?
1.1.5 Are ductwork and filters located outside the cleanrooms?
1.1.6 If fumigation procedures are used, is the facility designed to permit effective fumigation?
1.1.7 Is the number of air changes per hour adequate for defined areas?
1.1.8 Is the airflow adequate? [Minimal pressure differential (1.5mm H2O) maintained?]
1.1.9 Is room temperature and humidity effectively controlled?
1.2 COMPRESSED AIR
1.2.1 Is the air supply free from oil?
1.2.2 Is the air supply filtered through a sterilizing grade air filter?
1.2.3 Is humidity controlled?
1.3 CLEAN STEAM
1.3.1 Is clean steam used for sterilization of product contact surfaces?
1.3.2 Is the distribution system constructed of stainless steel treated to prevent corrosion and stopped for drainage?
Each point of the checklist shall be filled as applicable and comments or remarks, in addition, shall be given under the remarks column in the checklist.
Related Post: Audit Check List for Quality Assurance Pharmaceuticals
Note: The points mentioned in this Audit Check List for Engineering are not limited to these only.