%PDF-1.3 1 0 obj << /Type /Catalog /Outlines 2 0 R /Pages 3 0 R >> endobj 2 0 obj << /Type /Outlines /Count 0 >> endobj 3 0 obj << /Type /Pages /Kids [6 0 R 24 0 R 26 0 R 29 0 R 31 0 R 33 0 R 35 0 R ] /Count 7 /Resources << /ProcSet 4 0 R /Font << /F1 8 0 R /F2 9 0 R /F3 10 0 R /F4 11 0 R /F5 28 0 R >> /XObject << /I1 12 0 R /I2 13 0 R /I3 18 0 R /I4 19 0 R >> >> /MediaBox [0.000 0.000 595.280 841.890] >> endobj 4 0 obj [/PDF /Text /ImageC ] endobj 5 0 obj << /Creator (DOMPDF) /CreationDate (D:20220608135312-04'00') /ModDate (D:20220608135312-04'00') /Title (Investigations For Production Areas) >> endobj 6 0 obj << /Type /Page /Parent 3 0 R /Annots [ 14 0 R 16 0 R 20 0 R 22 0 R ] /Contents 7 0 R >> endobj 7 0 obj << /Length 5835 >> stream 1.000 1.000 1.000 rg 34.016 34.016 527.249 773.859 re f q 441.000 0 0 97.500 45.016 710.374 cm /I2 Do Q 0.000 0.000 0.000 rg BT 45.016 699.385 Td /F1 9.0 Tf [(Published on )] TJ ET BT 99.547 699.385 Td /F2 9.0 Tf [(IVT Network)] TJ ET BT 149.056 699.385 Td /F1 9.0 Tf [( \()] TJ ET BT 154.555 699.385 Td /F1 9.0 Tf [(http://www.ivtnetwork.com)] TJ ET 0.000 0.000 0.000 RG 0.18 w 0 J [ ] 0 d 154.555 698.234 m 259.081 698.234 l S BT 259.081 699.385 Td /F1 9.0 Tf [(\))] TJ ET 0.620 0.620 0.620 rg 45.016 686.888 506.159 0.750 re f 0.000 0.000 0.000 rg BT 45.016 662.142 Td /F3 15.0 Tf [(Investigations For Production Areas)] TJ ET q 45.016 580.047 506.159 63.986 re W n 0.800 0.800 0.800 rg 45.016 643.658 13.005 0.750 re f 0.000 0.000 0.000 rg BT 45.016 607.919 Td /F1 9.0 Tf [(By)] TJ ET 0.800 0.800 0.800 rg 58.021 643.658 94.527 0.750 re f q 31.500 0 0 31.500 61.771 612.533 cm /I4 Do Q 0.000 0.000 0.000 rg BT 152.548 633.044 Td /F4 9.0 Tf [(Jeanne Moldenhauer)] TJ ET 0.800 0.800 0.800 rg 152.548 643.658 109.062 0.750 re f 0.000 0.000 0.000 rg BT 152.548 609.794 Td /F4 9.0 Tf [(Jan 20, 2022 8:00 am EST)] TJ ET Q BT 426.494 544.035 Td /F3 24.0 Tf [(Audit Forum)] TJ ET 1.000 0.000 0.000 rg 45.016 522.657 506.159 5.250 re f 1.000 0.000 0.000 RG 0.75 w 0 J [ ] 0 d 45.391 523.032 505.409 4.500 re S 0.75 w 0 J [ ] 0 d 45.391 197.622 505.409 320.160 re S 0.000 0.000 0.000 rg BT 54.766 498.639 Td 1.502 Tw /F1 10.0 Tf [(Audit Forum provides readers an opportunity to discuss information, experiences, and practices within the )] TJ ET BT 54.766 486.429 Td 2.505 Tw /F1 10.0 Tf [(broad topic scope of audits. Discussion topics may include external and internal audits, best practices, )] TJ ET BT 54.766 474.219 Td 0.699 Tw /F1 10.0 Tf [(problem situations, and other areas of concern. Traditional audit activities as well as virtual audit topics may )] TJ ET BT 54.766 462.009 Td 0.000 Tw /F1 10.0 Tf [(be discussed.)] TJ ET BT 54.766 440.799 Td 1.854 Tw /F1 10.0 Tf [(Audits are a part of daily life in pharma, med devices, and other regulated industries. Audits used to be )] TJ ET BT 54.766 428.589 Td 0.799 Tw /F1 10.0 Tf [(relatively limited and generally routine in performance. In the old days, audits were conducted face-to-face )] TJ ET BT 54.766 416.379 Td 2.306 Tw /F1 10.0 Tf [(at the manufacturing site. Some audits began with facility tours and emphasized review of documented )] TJ ET BT 54.766 404.169 Td 0.719 Tw /F1 10.0 Tf [(procedures; others were more process oriented as opposed to document reviews. Interactions were direct )] TJ ET BT 54.766 391.959 Td 1.184 Tw /F1 10.0 Tf [(without PPE masks. Since then, we have evolved to virtual audits with Zoom technology with auditors and )] TJ ET BT 54.766 379.749 Td 2.043 Tw /F1 10.0 Tf [(company personnel offsite. Manufacturing facilities provide video technology for facility tours. Audits now )] TJ ET BT 54.766 367.539 Td 0.000 Tw /F1 10.0 Tf [(require new and different considerations, skill sets, training, and preparation; more changes are a certainty.)] TJ ET BT 54.766 346.329 Td /F1 10.0 Tf [(Topics previously addressed in Audit Forum include the following:)] TJ ET BT 72.110 325.437 Td /F1 9.0 Tf [(1.)] TJ ET BT 84.766 325.119 Td /F1 10.0 Tf [(Invitation to Participate. JGXP, V25, #3, May 2021)] TJ ET BT 72.110 313.227 Td /F1 9.0 Tf [(2.)] TJ ET BT 84.766 312.909 Td /F1 10.0 Tf [(Lessons From Previous FDA Observations Drugs. V25, #4, July 2021)] TJ ET BT 72.110 301.017 Td /F1 9.0 Tf [(3.)] TJ ET BT 84.766 300.699 Td /F1 10.0 Tf [(A Control Strategy Gone Wrong. JGXP, V25, #3, Sept 2021)] TJ ET BT 72.110 288.807 Td /F1 9.0 Tf [(4.)] TJ ET BT 84.766 288.489 Td /F1 10.0 Tf [(Audit Trails. JGXP V25, #6, Nov 2021)] TJ ET BT 54.766 267.279 Td 0.719 Tw /F1 10.0 Tf [(Journal submissions for publication in the Journal of Validation Technology and Journal of GXP Compliance )] TJ ET BT 54.766 255.069 Td 2.715 Tw /F1 10.0 Tf [(are most welcome. Blog discussions posted on the IVT Network are more informal and are also very )] TJ ET BT 54.766 242.859 Td 0.363 Tw /F1 10.0 Tf [(welcome. IVT Voices in Validation podcasts provide visual and verbal discussion by individuals and groups. )] TJ ET BT 54.766 230.649 Td 0.303 Tw /F1 10.0 Tf [(This Forum will succeed by contributions from the Quality and Compliance community. Please respond in the )] TJ ET BT 54.766 218.439 Td 0.000 Tw /F1 10.0 Tf [(comments section below with ideas, suggestions, or topics for discussion.)] TJ ET 1.000 0.000 0.000 rg BT 45.016 176.525 Td /F4 12.0 Tf [(ABSTRACT)] TJ ET 0.000 0.000 0.000 rg BT 45.016 154.827 Td 0.415 Tw /F1 10.0 Tf [(Many deviations and investigations occur due to issues in the production system in pharmaceutical facilities, e.g., )] TJ ET BT 45.016 142.617 Td 0.649 Tw /F1 10.0 Tf [(presence of particulate matter in product, equipment malfunctions, failure to meet operational parameters, failure )] TJ ET BT 45.016 130.407 Td 0.785 Tw /F1 10.0 Tf [(to meet control parameters, and the like. According to European Compliance Academy \(ECA, 2019\), there were )] TJ ET BT 45.016 118.197 Td 0.284 Tw /F1 10.0 Tf [(21 Warning Letters issued relative to issues with review of Production Batch Records. Depending upon your point )] TJ ET BT 45.016 105.987 Td 0.562 Tw /F1 10.0 Tf [(of view, these may be either production issues or quality issues, or both. This paper describes considerations for )] TJ ET BT 45.016 93.777 Td 0.324 Tw /F1 10.0 Tf [(conducting investigations relative to deviations that occur in the production system, although deviations may have )] TJ ET BT 45.016 81.567 Td 0.000 Tw /F1 10.0 Tf [(been issued to the laboratory, utility, or quality system \(Moldenhauer, 2020\).)] TJ ET BT 45.016 70.334 Td /F4 9.0 Tf [(Examples of Deviations in The Production System)] TJ ET endstream endobj 8 0 obj << /Type /Font /Subtype /Type1 /Name /F1 /BaseFont /Helvetica /Encoding /WinAnsiEncoding >> endobj 9 0 obj << /Type /Font /Subtype /Type1 /Name /F2 /BaseFont /Helvetica-Oblique /Encoding /WinAnsiEncoding >> endobj 10 0 obj << /Type /Font /Subtype /Type1 /Name /F3 /BaseFont /Times-Roman /Encoding /WinAnsiEncoding >> endobj 11 0 obj << /Type /Font /Subtype /Type1 /Name /F4 /BaseFont /Helvetica-Bold /Encoding /WinAnsiEncoding >> endobj 12 0 obj << /Type /XObject /Subtype /Image /Width 588 /Height 130 /Filter /FlateDecode /DecodeParms << /Predictor 15 /Colors 1 /Columns 588 /BitsPerComponent 8>> /ColorSpace /DeviceGray /BitsPerComponent 8 /Length 8715>> stream x]OK#MDA+x !\K ބ {o/|ygz&Y}Nt]]]UyD~|VVd`蓨CFAgy~u2W!Bm}u%2gSFDK_]惂la蓨-L}U)ϢKݯDFsA0_]恊W"+ Sk<`k
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