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
Recommended Citation
Idrizi, Edita Alili; Bexheti, Dorentina; Lika, Sihana Ahmeti; Dauti, Merita; Zajmi, Arlinda Haxhiu; and Ballazhi, Lulzime, "Internal Audit as a Management Tool in Pharmaceutical Industry" (2021). UBT International Conference. 147.
https://knowledgecenter.ubt-uni.net/conference/2021UBTIC/all-events/147
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.