Event Title

Internal Audit as a Management Tool in Pharmaceutical Industry

Session

Pharmaceutical and Natural Sciences

Description

The internal audit is an important control function within a pharmaceutical industry. It ensures a thorough analyses and evaluation of the company activities and informs the management on the effectiveness of the company quality controls of their processes and products. These audits ensure compliance with Good Manufacturing Practice (GMP) requirements. A well designed checklist is a key tool to assist in conducting an internal audit. It consists of several series of questions that will help verifying if the control system maintains GMP compliance and to find and address any violations or critical items. Although, internal audit is not a regulation requirement, the information obtained from it, can play a valuable role in production, process performance and quality monitoring as outlined in ICH Q10.

Keywords:

Internal audit, GMP, checklist, quality control.

Proceedings Editor

Edmond Hajrizi

ISBN

978-9951-550-47-5

First Page

1

Location

UBT Kampus, Lipjan

Start Date

30-10-2021 12:00 AM

End Date

30-10-2021 12:00 AM

DOI

10.33107/ubt-ic.2021.80

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Oct 30th, 12:00 AM Oct 30th, 12:00 AM

Internal Audit as a Management Tool in Pharmaceutical Industry

UBT Kampus, Lipjan

The internal audit is an important control function within a pharmaceutical industry. It ensures a thorough analyses and evaluation of the company activities and informs the management on the effectiveness of the company quality controls of their processes and products. These audits ensure compliance with Good Manufacturing Practice (GMP) requirements. A well designed checklist is a key tool to assist in conducting an internal audit. It consists of several series of questions that will help verifying if the control system maintains GMP compliance and to find and address any violations or critical items. Although, internal audit is not a regulation requirement, the information obtained from it, can play a valuable role in production, process performance and quality monitoring as outlined in ICH Q10.