Evaluation of Validation Plans and Validation Activities in Iranian Pharmaceutical Industries

Abstract

One of the main elements for fulfilling Good Manufacturing Practice (GMP) requirements is validation performance. Therefore, those pharmaceutical factories trying to synchronize cGMP compliance should fulfill validation requirements. With accepting Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co- operation Scheme (PIC/S) standards by Iran Food and Drug Administration (FDA), pharmaceutical factories are required to perform such a validation. Despite the gap existing between production conditions and PIC/S standards, pharmacy factories are extremely rushing for their quality improvement. In this study, 84 factories were checked for having validation master plan (VMP), in their company. Then, a complete checklist was provided by checking WHO, PIC/S, and FDA guidelines of all VMP requirements. Those pharmaceutical factories, which have VMP or are providing it, have put in three categories. The first group performed validation project on their own. The second group got help from an Iranian adviser, and the third group performed it with foreign adviser company assistance. The results of these three categories are quantified and compared with each other by one-way ANOVA test. About 60 factories of 84 answered the initial questionnaire. About 26 factories of the same number introduced themselves for having VMP, and seven factories were providing it. Comparing these three categories, the second and third groups with P < 0.05 do not differ from each other very much statistically. With respect to quality of their VMP, the first group with P > 0.05 is very different from the two other groups, while it has a lower average from them.