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Page 8 of 42 eBook December 2019 BioPharm International 9 have i mpl ic at ion s for pro duc t quality and supply. Data showed that there has been a consistent reduction in the issuance of VAI and OA I since 2017, suggesting a higher rate of compliance with r e g u l a t o r y g u i d a n c e r e q u i r e - ments,as fou nd du r i ng i nspec- tions. The finished formulation and API site inspection trend ( Figure 4) indicates a declining domestic inspections trend; however, there was no corresponding increase in foreig n site inspec tions, which may reflect the fact that FDA has adopted a risk-based inspection ma nagement process. T he data were also analyzed to determine w h e t h e r t h e r e w e r e a ny c o r- relations between the variables: number of VAI/OAI, number of domestic inspections, and num- ber of foreign inspections. Based on the Pearson correla- tion coefficient calculation of X values (domestic inspections) and Y values (number of VA I/OA I), the value of R is 0.9443, suggest- ing a strong positive correlation between X and Y variables. The p-value is 0.015648, hence statisti- cally significant (<0.05). The cor- relation was not seen when VAI/ OAI numbers were compared with foreign inspection trend. It can be, therefore, concluded that there is a higher tendency to generate VAI/ OAI observations if the domestic inspection rate increases. T h e P e a r s o n C o r r e l a t i o n Coefficient for individual GMP observations associated with the nine subparts (B through J) were analyzed for 2014 through 2018 (Figure 5 a and b). A positive correla- tion could be ascertained across laborator y control obser vations (Subpart I) and records and reports (Subpart J). This may suggest that i nc r e a s e d r eg u l ator y s c r ut i ny of laboratory controls may have resulted in improved good docu- mentation practices, because there appeared to be an improvement in records and reports observations as well. A summary of statistics is found in Figure 6. A lthough additional analysis might be required to confirm the correlation, it is safe to assume that laborator y data integ r it y-based i nspec t ion assessment e xtends from GMP sections Subpart J to Subpart I. As an inspection readi- ness strategy, organizations should provide equal weight to laboratory electronic controls, procedures, specif ications, and methods as well as to data access and integrity (6), and to the storage of raw data and reports, whether electronic or paper. CONCLUSION Analysis of FDA Form 483 obser- vations issued from 2014 to 2018 r e v e a l e d t h at t h e nu m b e r o f Regulatory Sourcebook FDA Inspections Figure 4. Voluntary Action Indicated (VAI), Official Action Indicated (OAI) and domestic, foreign inspections of finished formulation and API sites. VAI OAI Foreign Insoections Domestic Inspections 500 1,000 1,500 2014 2015 2016 2017 2018 Figure 5a. Pearson correlation coefficient. X Values Y Values 1117 1362 1545 1581 1690 1117 1362 1545 1581 1690 X Values Y Values X Values Y Values X and Y Combined R Calculation ∑ = 7295 Mean = 1459 ∑(X - Mx)2 = SSx = 202014 ∑ = 6758 Mean = 1351.6 ∑(Y - My)2 = SSy = 117347.2 N = 5 ∑(X - Mx)(Y - My) = 145385 r = ∑((X - My)(Y - Mx)) / √((SSx)(SSy)) r = 145385 / √((202014)(117347.2)) = 0.9443 Figure 5b: Result details and calculation.

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