Experiences of using the GMP audit preparation tool in pharmaceutical contract manufacturer audits.
BACKGROUND
Use of external contractors is nowadays inevitable in the pharmaceutical industry. Therefore the amount of current good manufacturing practice audits has been increasing. During the audit, a large amount of items should be covered in a limited amount of time. Consequently, pharmaceutical companies should have systematic and effective ways to manage and prepare for the audits. This study is a continuation to the earlier study, where a tool for the preparation of cGMP audit was developed and its content was validated. The objective of this study was to evaluate the usefulness of the developed tool in audit preparation and during the actual cGMP audit.


METHODS
Three qualitative research methods were used in this study (observation, interviews, and opinion survey). First, the validity of the information given through the tool was examined by comparing the responses to the actual conditions observed during the contract manufacturer audits (n = 15). Additionally the opinions of the contract manufacturers of the tool were gathered (n = 10) and the auditors were interviewed (n = 2).


RESULTS
The developed tool was proven to be useful in audit preparation phase from both the auditor's and the contract manufacturers' point of view. Furthermore, using the tool can also save some time when performing the audit.


CONCLUSIONS
The results show that using the tool can give significant support in audit preparation phase and also during the actual audit.
Linna
Anu
A
Division of Industrial Pharmacy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland. anu.linna@orion.fi
Korhonen
Mirka
M
Airaksinen
Marja
M
Juppo
Anne Mari
AM
D003284:Contract Services; D004345:Drug Industry / Q000379:methods* / Q000592:standards*; D019983:Guideline Adherence; D008330:Management Audit / Q000379:methods* / Q000592:standards*