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8 BioPharm International eBook December 2019 www.biopharminternational.com any positive correlation between t he v a r i a b l e s , w he r e p o s it i v e correlation indicates that as the values of one var iable increase the values of the other variable increase (5). RESULTS AND DISCUSSION B e t w e e n 2 014 a n d 2 018 , t h e total number of FDA Form 483 audit observations was found to range from 2997 to 3626, with an average of 3362 observations per year. The agenc y issued a total of 3424 Form 483s, an average of 685 per year. However, 716 483s we re i ssue d i n 2 018, a h ig he r nu mber t ha n seen i n prev ious years (Figure 1 and Table I). Figure 2 and Table II summarize the nine categories of inspection observations and associated sub- sections. The data provide a clear indi- cat ion t hat most 483 obser va- t ion s we r e r e l ate d to Sub p a r t I – l a b o r a t o r y c o nt r o l s , w h i c h a c c o u nt e d f o r 2 6 0 3 o b s e r v a - tions, and Subpart J–records and reports, with 2530 observations. The other top contributors were Subpar t F –produc tion and pro - cess controls (w ith 2088 obser- vations), Subpart B –organization and personnel (with 1902 obser- vations), and Subpart D – equip - ment (with 1621 observations). F i g u r e 3 i l l u s t r a t e s t h e p e r- centage cha nges i n t he ident i- fied observation categories. The most relevant fluctuations would be the increase in FDA observa- t ions for pac k ag i ng a nd lab el- ing control (Subpart G) in 2017 a nd 2 018 . A l s o notewor t hy i s the spike in equipment (Subpart D) o b s e r v at io n s , w h ic h w e nt f rom 311 to 370 bet ween 2 017 a nd 2 018. However, laborator y cont rol obser vat ions dec reased during the same period, which may ref lect the implementation of i mpr ove d s y ste m a nd d at a integrity laboratory controls. VAI AND OAI TRENDS VAI and OAI are critical for com- p a n ie s, b e c au s e t he y i nd ic ate non- compl ia nce a nd t he ne e d for cr itical ac tions, which may Regulatory Sourcebook FDA Inspections Figure 2. Number of observations by good manufacturing practice (GMP) subsections 3000 2500 2000 1500 1000 500 -500 Subpart B, 1902 Subpart D, 1621 Subpart C, 959 Subpart E, 615 Subpart F, 2088 Subpart I, 2603 Subpart J, 2530 Subpart G, Subpart H, 209 0 Total observations, 2015-2018 Subpart Subpart B Subpart C Subpart D Subpart E Subpart F Subpart G Subpart H Subpart I Subpart J 2018 424 158 370 124 367 51 45 501 485 2017 401 161 311 127 415 31 42 526 532 2016 359 236 342 132 422 42 39 575 495 2015 379 249 313 132 493 39 40 544 554 2014 339 155 285 100 391 30 43 457 464 Total 1902 959 1621 615 2088 193 209 2603 2530 Table II: 483 observations, final drug product and API 2014-2018. Figure 3. Change of observation types, year over year (in percentages). 0.8 % Change 2018 % Change 2017 % Change 2016 % Change 2015 0.6 0.4 0.2 0 -0.2 Subpart B Subpart G Subpart C Subpart H Subpart D Subpart I Subpart E Subpart F Subpart J -0.4