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Audit Check List for Engineering Department

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:

Audit Checklist for Eng. department

1.0 Audit Check List for Engineering Related to Support 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?


1.2.1 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?


1.3.1 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.

  • Naresh Bhakar

    Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has exprience in Pharma manufactring and worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don't hesitate to reach out via email at [email protected].

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