%PDF-1.3 1 0 obj << /Type /Catalog /Outlines 2 0 R /Pages 3 0 R /Names <> >> endobj 2 0 obj << /Type /Outlines /Count 0 >> endobj 3 0 obj << /Type /Pages /Kids [6 0 R 23 0 R 25 0 R 27 0 R ] /Count 4 /Resources << /ProcSet 4 0 R /Font << /F1 8 0 R /F2 9 0 R /F3 10 0 R /F4 11 0 R /F5 12 0 R >> /XObject << /I1 13 0 R /I2 14 0 R /I3 21 0 R /I4 22 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:20161209214451-08'00') /ModDate (D:20161209214451-08'00') /Title (cGMP Maintenance Program Considerations) /Subject (This paper provides general elements of a site preventive maintenance program including record-keeping and personnel qualifications.) /Keywords (cGMP, maintenance, JVT) >> endobj 6 0 obj << /Type /Page /Parent 3 0 R /Annots [ 15 0 R 17 0 R 19 0 R ] /Contents 7 0 R >> endobj 7 0 obj << /Length 4604 >> stream 1.000 1.000 1.000 rg 34.016 34.016 527.249 773.859 re f q 302.250 0 0 72.000 45.016 735.874 cm /I2 Do Q 0.000 0.000 0.000 rg BT 45.016 724.885 Td /F1 9.0 Tf [(Published on )] TJ ET BT 99.547 724.885 Td /F2 9.0 Tf [(IVT Network)] TJ ET BT 149.056 724.885 Td /F1 9.0 Tf [( \()] TJ ET BT 154.555 724.885 Td /F1 9.0 Tf [(http://www.ivtnetwork.com)] TJ ET 0.000 0.000 0.000 RG 0.18 w 0 J [ ] 0 d 154.555 723.734 m 259.081 723.734 l S BT 259.081 724.885 Td /F1 9.0 Tf [(\))] TJ ET 0.620 0.620 0.620 rg 45.016 712.388 506.159 0.750 re f 0.000 0.000 0.000 rg BT 45.016 687.642 Td /F3 15.0 Tf [(cGMP Maintenance Program Considerations)] TJ ET q 45.016 635.783 506.159 33.750 re W n 0.800 0.800 0.800 rg 45.016 669.158 13.005 0.750 re f 0.000 0.000 0.000 rg BT 45.016 649.169 Td /F1 9.0 Tf [(By)] TJ ET 0.800 0.800 0.800 rg 58.021 669.158 74.520 0.750 re f 0.000 0.000 0.000 rg BT 58.021 651.044 Td /F4 9.0 Tf [(Joseph Busfield)] TJ ET 0.800 0.800 0.800 rg 132.541 669.158 114.066 0.750 re f 0.000 0.000 0.000 rg BT 132.541 651.044 Td /F4 9.0 Tf [(Jan 10, 2013 11:59 am PST)] TJ ET Q BT 45.016 465.179 Td /F4 9.0 Tf [(ABSTRACT)] TJ ET BT 45.016 451.443 Td /F1 9.0 Tf [()] TJ ET BT 45.016 437.707 Td /F1 9.0 Tf [(Facilities governed by current good manufacturing practices \(cGMPs\) must remain in a validated state. The site preventive )] TJ ET BT 45.016 423.971 Td /F1 9.0 Tf [(maintenance program is a critical part of this effort. Requirements for equipment are stated in 21 Code of Federal Regulations )] TJ ET BT 45.016 410.234 Td /F1 9.0 Tf [(\(CFR\) 211.67. All facility, process, utility, and laboratory equipment used in the manufacturing, processing, packing, holding, )] TJ ET BT 45.016 396.498 Td /F1 9.0 Tf [(or testing of drug products, biological products, or medical devices must be characterized as GMP or non-GMP. This article )] TJ ET BT 45.016 382.762 Td /F1 9.0 Tf [(provides general elements of a site preventive maintenance program including record-keeping and personnel qualifications.)] TJ ET BT 45.016 369.026 Td /F1 9.0 Tf [()] TJ ET BT 45.016 355.289 Td /F4 9.0 Tf [(INTRODUCTION)] TJ ET BT 45.016 341.553 Td /F1 9.0 Tf [()] TJ ET BT 45.016 327.817 Td /F1 9.0 Tf [(After all the excitement of qualifying and validating a new facility or new equipment is added to a facility, it falls on the )] TJ ET BT 45.016 314.081 Td /F1 9.0 Tf [(maintenance department to keep that facility and equipment in the validated state. If left to itself, the second law of )] TJ ET BT 45.016 300.344 Td /F1 9.0 Tf [(thermodynamics tells us that the facility and equipment will naturally gravitate to a state of greater disorder. Equipment will )] TJ ET BT 45.016 286.608 Td /F1 9.0 Tf [(wear out, develop corrosion, and so on. As soon as the validation effort is complete, final reports are signed, and the )] TJ ET BT 45.016 272.872 Td /F1 9.0 Tf [(equipment put to use, it starts wearing out and moving toward a different state than when the equipment and facility was )] TJ ET BT 45.016 259.136 Td /F1 9.0 Tf [(originally qualified/validated. All facilities and equipment must be maintained to stave off the effects of disarray. Beyond the )] TJ ET BT 45.016 245.399 Td /F1 9.0 Tf [(financial burden experienced by all industries, the industries governed by cGMPs have the burden to maintain a facility in a )] TJ ET BT 45.016 231.663 Td /F1 9.0 Tf [(validated state required by the cGMP.)] TJ ET BT 45.016 217.927 Td /F1 9.0 Tf [()] TJ ET BT 45.016 204.191 Td /F4 9.0 Tf [(REGULATORY REQUIREMENTS)] TJ ET BT 45.016 190.454 Td /F1 9.0 Tf [(Requirements for equipment are stated in 21 CFR 211.67 as follows:)] TJ ET BT 45.016 176.718 Td /F1 9.0 Tf [()] TJ ET BT 67.516 162.982 Td /F2 9.0 Tf [(211.67 Equipment cleaning and maintenance.)] TJ ET BT 67.516 149.246 Td /F1 9.0 Tf [()] TJ ET BT 67.516 135.509 Td /F2 9.0 Tf [(\(a\) Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions )] TJ ET BT 67.516 121.773 Td /F2 9.0 Tf [(or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or )] TJ ET BT 67.516 108.037 Td /F2 9.0 Tf [(other established requirements.)] TJ ET BT 67.516 94.301 Td /F1 9.0 Tf [()] TJ ET 0.890 0.929 0.737 RG 1.5 w 0 J [ ] 0 d 64.516 509.783 147.000 117.750 re S q 145.500 0 0 116.250 65.266 510.533 cm /I4 Do Q 0.776 0.776 0.776 rg 0.776 0.776 0.776 RG 63.766 483.668 m 212.266 483.668 l 212.266 484.418 l 63.766 484.418 l f 0.439 0.439 0.439 rg BT 63.766 490.841 Td /F5 9.0 Tf [(Getty Images)] 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 /Font /Subtype /Type1 /Name /F5 /BaseFont /Times-Bold /Encoding /WinAnsiEncoding >> endobj 13 0 obj << /Type /XObject /Subtype /Image /Width 403 /Height 96 /Filter /FlateDecode /DecodeParms << /Predictor 15 /Colors 1 /Columns 403 /BitsPerComponent 8>> /ColorSpace /DeviceGray /BitsPerComponent 8 /Length 4204>> stream x\WǯzED+ƈWEZkQUQFĨkTZ5FĈU֫FTU5"*QQWEED\QQc=v1Tq/u[Pҙs6_nJ:0M:ko62o>nJxj62t[_ Q}W$ۈRN%:n#J:#n#J:G6 rs`VthGnۊRB)I'ɟmE)M;G\.g#BmE)MGu(tۄ>n3Jiz:LϯیRJύ(r!tCivRI\./R$_YLu?'z8}7|k)EiX3$?\k^&qƍ$xBqW =IQdkr{8Ҿ]HwE+'鵷LBtM[uc Y)ٳCWGu4Jz#7NIqZcq竃Џ"`yo>n\ >Sm6l:a/V,D AMь_?wčOo-$6I u0r\'z>fNwcx&b '"0k_?s^{/Χ$Nf0!b"%٨& hhk#q&9 `Bfu38g8JRbH&o3c~pGoꁷ[Ё5OuF< 0m{|L&rl|}- a|3of"0O=;đg0 nN䢕02m>Yw9΋5?#8l% օbgq*H_MlE/Zi1s|g&r(ŶRS|X3sFU/ /6zRkq^lhX8(w*40D:@_Ԑ1 ޖӈ-}ԂL'ga 2VrM)^&ڭ8i 3 3Ϋi$m42k9G@d,\Sɳj7mq&Z,LT&y ޴Fs_Onp_&B gp)$xWGm;/mmDw^jΫes;* (z~8)%0Qfb!r^Z#90i6-&RR!~c&jf2[r^#㒦5C?GMliLTExN#So*S_~u%&FyԝY1r^ZTJ MM2q&C?Iei]I}K$ɨrAj;)*J}|mJiLBk|WcdRuW9=@m/|ys'SoE+"_sW !tl4`&&U)%3?=2*/\I kel4` {c{Bc>2 7yޫG3 Iy1aAFϓe1xޫORҙ}ؽ9ּ *Ƅ 19(F3ƶs *`L'iS |}KԾAo=\DPHy;nbR }59 {>{ nԥ~ފ}m<_tI}LLZ`!&lLrǎq{fF3U+٩zS'Q}t…Sz1z. 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ZpQ/b%X5h1tjޭ#/kct4u.z\i}cAXc5{_EQUYp|GJ4kK5X̰NVN+%>dblg P=uIe+L涺 *0I<\%d ZȎu&<L!$-KO~e5s& m%Z e CQ(FHghM C,0K Fͱ/r| ׆Cf !ԡmmbDbl_!ks8[N iؓa$"@%-02CJ>Fɔ?'~%e}(4"QvMdQX(yNz+$ ajNH,.9&%C3u^̻O)uvƼyX̓I)x!0#0V+/AR25z`-P|`n8~v*?0:38 o oHt>T+z2K-jjDs AqIѐcB}k_$pA8#A&{p_0b0*RPQQ. ī?'+EUI" HdT=D "?6)h㠅!9c 67`weUzPyKr&e8awO> endobj 24 0 obj << /Length 8044 >> stream 0.439 0.439 0.439 rg 0.776 0.776 0.776 RG 1.5 w 0 J [ ] 0 d 1.000 1.000 1.000 rg 34.016 34.016 527.249 773.859 re f 0.000 0.000 0.000 rg BT 67.516 796.885 Td /F2 9.0 Tf [(\(b\) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, )] TJ ET BT 67.516 783.149 Td /F2 9.0 Tf [(used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not )] TJ ET BT 67.516 769.413 Td /F2 9.0 Tf [(necessarily limited to, the following:)] TJ ET BT 67.516 755.677 Td /F1 9.0 Tf [()] TJ ET BT 90.016 741.940 Td /F2 9.0 Tf [(\(1\) Assignment of responsibility for cleaning and maintaining equipment)] TJ ET BT 90.016 728.204 Td /F2 9.0 Tf [(\(2\) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules)] TJ ET BT 90.016 714.468 Td /F2 9.0 Tf [(\(3\) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance )] TJ ET BT 90.016 700.732 Td /F2 9.0 Tf [(operations, and the methods of disassembling and reassembling equipment as necessary to assure proper )] TJ ET BT 90.016 686.995 Td /F2 9.0 Tf [(cleaning and maintenance)] TJ ET BT 90.016 673.259 Td /F2 9.0 Tf [(\(4\) Removal or obliteration of previous batch identification)] TJ ET BT 90.016 659.523 Td /F2 9.0 Tf [(\(5\) Protection of clean equipment from contamination prior to use)] TJ ET BT 90.016 645.787 Td /F2 9.0 Tf [(\(6\) Inspection of equipment for cleanliness immediately before use)] TJ ET BT 90.016 632.050 Td /F1 9.0 Tf [()] TJ ET BT 67.516 618.314 Td /F2 9.0 Tf [(\(c\) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in 211.180 and 211.182. \(1\))] TJ ET BT 45.016 604.578 Td /F1 9.0 Tf [()] TJ ET BT 45.016 590.842 Td /F1 9.0 Tf [(This is one of the more clear directions provided in the CFR, yet one of the more overlooked. Much too often the maintenance )] TJ ET BT 45.016 577.105 Td /F1 9.0 Tf [(operation is viewed by management as a cost center. Maintenance is considered a necessary evil, but one available for cost )] TJ ET BT 45.016 563.369 Td /F1 9.0 Tf [(cutting and overhead reduction. Maintenance is a quality requirement, clearly laid out in the CFR and an obvious necessity to )] TJ ET BT 45.016 549.633 Td /F1 9.0 Tf [(maintain the validated state. Funds allocated for maintenance must be protected and preserved to maintain the validated )] TJ ET BT 45.016 535.897 Td /F1 9.0 Tf [(state.)] TJ ET BT 45.016 522.160 Td /F1 9.0 Tf [()] TJ ET BT 45.016 508.424 Td /F1 9.0 Tf [(What follows are considerations for a compliant maintenance program.)] TJ ET BT 45.016 494.688 Td /F1 9.0 Tf [()] TJ ET BT 45.016 480.952 Td /F4 9.0 Tf [(CHARACTERIZATION AND CLASSIFICATION)] TJ ET BT 45.016 467.215 Td /F1 9.0 Tf [()] TJ ET BT 45.016 453.479 Td /F1 9.0 Tf [(All facility, process, utility, and laboratory equipment used in the manufacturing, processing, packing, holding, or testing of )] TJ ET BT 45.016 439.743 Td /F1 9.0 Tf [(drug products, biological products, or medical devices must be characterized as GMP or non-GMP according to their use in )] TJ ET BT 45.016 426.007 Td /F1 9.0 Tf [(the GMP environment. This characterization must recognize that in a pharmaceutical, biological, diagnostic or related industry, )] TJ ET BT 45.016 412.270 Td /F1 9.0 Tf [(the majority of equipment exists to monitor or control some aspect of the manufacturing operation and are therefore part of )] TJ ET BT 45.016 398.534 Td /F1 9.0 Tf [(GMP. Filling and packaging equipment and systems should be maintained by a system incorporating the same characteristics )] TJ ET BT 45.016 384.798 Td /F1 9.0 Tf [(as the maintenance system for GMP process, facility and utilities. There should be procedures defining the rationale and )] TJ ET BT 45.016 371.062 Td /F1 9.0 Tf [(approach for classifying equipment as GMP or non-GMP.)] TJ ET BT 45.016 357.325 Td /F1 9.0 Tf [()] TJ ET BT 45.016 343.589 Td /F1 9.0 Tf [(Some sites go farther and apply the terms critical and non-critical to equipment in the preventive maintenance program. This )] TJ ET BT 45.016 329.853 Td /F1 9.0 Tf [(adds little benefit, and may present a compliance risk. How would preventive maintenance be done differently for a critical )] TJ ET BT 45.016 316.117 Td /F1 9.0 Tf [(versus a non-critical piece of equipment? This further delineation beyond GMP and non-GMP could be used to establish limits )] TJ ET BT 45.016 302.380 Td /F1 9.0 Tf [(and trigger out-of-tolerance events in a calibration program, but not so in a preventive maintenance program. Likewise a few )] TJ ET BT 45.016 288.644 Td /F1 9.0 Tf [(sites go even further and classify equipment parts as critical and non-critical. This can be an unnecessary complication. The )] TJ ET BT 45.016 274.908 Td /F1 9.0 Tf [(same part, such as a belt, could be used for both GMP and non-GMP equipment. Complexity without a compliance benefit )] TJ ET BT 45.016 261.172 Td /F1 9.0 Tf [(adds compliance risk!)] TJ ET BT 45.016 247.435 Td /F1 9.0 Tf [()] TJ ET BT 45.016 233.699 Td /F4 9.0 Tf [(GENERAL PROGRAM ELEMENTS)] TJ ET BT 45.016 219.963 Td /F1 9.0 Tf [()] TJ ET BT 45.016 206.227 Td /F1 9.0 Tf [(Maintenance in a GMP environment is part of the overall compliance effort of the site. The maintenance program is not only )] TJ ET BT 45.016 192.490 Td /F1 9.0 Tf [(instituted to maintain equipment correctly, ensuring availability and proper operation, but also to maintain the validated state of )] TJ ET BT 45.016 178.754 Td /F1 9.0 Tf [(equipment used in the manufacturing, processing, packing, holding, or testing of a regulated product. The maintenance )] TJ ET BT 45.016 165.018 Td /F1 9.0 Tf [(program must consider the following components:)] TJ ET 0.000 0.000 0.000 RG 69.866 145.946 m 69.866 146.358 69.696 146.768 69.404 147.059 c 69.113 147.351 68.703 147.521 68.291 147.521 c 67.878 147.521 67.469 147.351 67.177 147.059 c 66.885 146.768 66.716 146.358 66.716 145.946 c 66.716 145.533 66.885 145.123 67.177 144.832 c 67.469 144.540 67.878 144.371 68.291 144.371 c 68.703 144.371 69.113 144.540 69.404 144.832 c 69.696 145.123 69.866 145.533 69.866 145.946 c f BT 75.016 142.282 Td /F1 9.0 Tf [(There should be maintenance program administrative procedures outlining details to prepare and approve preventive )] TJ ET BT 75.016 128.545 Td /F1 9.0 Tf [(maintenance regimens, execute preventive and corrective maintenance, review and approve work orders, report late )] TJ ET BT 75.016 114.809 Td /F1 9.0 Tf [(preventive maintenance, open corrective maintenance procedures, and all associated activities.)] TJ ET 69.866 104.737 m 69.866 105.149 69.696 105.559 69.404 105.850 c 69.113 106.142 68.703 106.312 68.291 106.312 c 67.878 106.312 67.469 106.142 67.177 105.850 c 66.885 105.559 66.716 105.149 66.716 104.737 c 66.716 104.324 66.885 103.915 67.177 103.623 c 67.469 103.331 67.878 103.162 68.291 103.162 c 68.703 103.162 69.113 103.331 69.404 103.623 c 69.696 103.915 69.866 104.324 69.866 104.737 c f BT 75.016 101.073 Td /F1 9.0 Tf [(There should be individual procedures prepared for the preventive maintenance of specific GMP equipment. These )] TJ ET BT 75.016 87.337 Td /F1 9.0 Tf [(procedures should be reviewed and approved by quality, operations, and technical personnel. The activity procedures )] TJ ET BT 75.016 73.600 Td /F1 9.0 Tf [(required should be associated with risk to patient and organization.)] TJ ET 69.866 63.528 m 69.866 63.940 69.696 64.350 69.404 64.642 c 69.113 64.933 68.703 65.103 68.291 65.103 c 67.878 65.103 67.469 64.933 67.177 64.642 c 66.885 64.350 66.716 63.940 66.716 63.528 c 66.716 63.116 66.885 62.706 67.177 62.414 c 67.469 62.123 67.878 61.953 68.291 61.953 c 68.703 61.953 69.113 62.123 69.404 62.414 c 69.696 62.706 69.866 63.116 69.866 63.528 c f BT 75.016 59.864 Td /F1 9.0 Tf [(The preventive maintenance procedures must specify tasks and frequency for each task. Risk analysis should be )] TJ ET endstream endobj 25 0 obj << /Type /Page /Parent 3 0 R /Contents 26 0 R >> endobj 26 0 obj << /Length 14207 >> stream 0.000 0.000 0.000 rg 0.000 0.000 0.000 RG 1.5 w 0 J [ ] 0 d 1.000 1.000 1.000 rg 34.016 34.016 527.249 773.859 re f 0.000 0.000 0.000 rg BT 75.016 796.885 Td /F1 9.0 Tf [(considered these determinations.)] TJ ET 69.866 786.813 m 69.866 787.225 69.696 787.635 69.404 787.927 c 69.113 788.218 68.703 788.388 68.291 788.388 c 67.878 788.388 67.469 788.218 67.177 787.927 c 66.885 787.635 66.716 787.225 66.716 786.813 c 66.716 786.401 66.885 785.991 67.177 785.699 c 67.469 785.408 67.878 785.238 68.291 785.238 c 68.703 785.238 69.113 785.408 69.404 785.699 c 69.696 785.991 69.866 786.401 69.866 786.813 c f BT 75.016 783.149 Td /F1 9.0 Tf [(There should be a procedure for tracking scheduled maintenance activities.)] TJ ET 69.866 773.077 m 69.866 773.489 69.696 773.899 69.404 774.190 c 69.113 774.482 68.703 774.652 68.291 774.652 c 67.878 774.652 67.469 774.482 67.177 774.190 c 66.885 773.899 66.716 773.489 66.716 773.077 c 66.716 772.664 66.885 772.255 67.177 771.963 c 67.469 771.671 67.878 771.502 68.291 771.502 c 68.703 771.502 69.113 771.671 69.404 771.963 c 69.696 772.255 69.866 772.664 69.866 773.077 c f BT 75.016 769.413 Td /F1 9.0 Tf [(The quality unit should review all systems and procedures, including procedures entered into a computerized )] TJ ET BT 75.016 755.677 Td /F1 9.0 Tf [(maintenance management system \(CMMS\). A computerized list of tasks and frequencies stands in the place of a )] TJ ET BT 75.016 741.940 Td /F1 9.0 Tf [(standard operating procedure \(SOP\) and should be treated as such.)] TJ ET 69.866 731.868 m 69.866 732.280 69.696 732.690 69.404 732.982 c 69.113 733.273 68.703 733.443 68.291 733.443 c 67.878 733.443 67.469 733.273 67.177 732.982 c 66.885 732.690 66.716 732.280 66.716 731.868 c 66.716 731.456 66.885 731.046 67.177 730.754 c 67.469 730.463 67.878 730.293 68.291 730.293 c 68.703 730.293 69.113 730.463 69.404 730.754 c 69.696 731.046 69.866 731.456 69.866 731.868 c f BT 75.016 728.204 Td /F1 9.0 Tf [(Where CMMS is employed, it must be validated/qualified for its intended use. Any associated computerized systems )] TJ ET BT 75.016 714.468 Td /F1 9.0 Tf [(must also be appropriately validated/qualified.)] TJ ET 69.866 704.396 m 69.866 704.808 69.696 705.218 69.404 705.509 c 69.113 705.801 68.703 705.971 68.291 705.971 c 67.878 705.971 67.469 705.801 67.177 705.509 c 66.885 705.218 66.716 704.808 66.716 704.396 c 66.716 703.983 66.885 703.573 67.177 703.282 c 67.469 702.990 67.878 702.821 68.291 702.821 c 68.703 702.821 69.113 702.990 69.404 703.282 c 69.696 703.573 69.866 703.983 69.866 704.396 c f BT 75.016 700.732 Td /F1 9.0 Tf [(Equipment should be clearly identified by a unique number.)] TJ ET 69.866 690.659 m 69.866 691.072 69.696 691.481 69.404 691.773 c 69.113 692.065 68.703 692.234 68.291 692.234 c 67.878 692.234 67.469 692.065 67.177 691.773 c 66.885 691.481 66.716 691.072 66.716 690.659 c 66.716 690.247 66.885 689.837 67.177 689.546 c 67.469 689.254 67.878 689.084 68.291 689.084 c 68.703 689.084 69.113 689.254 69.404 689.546 c 69.696 689.837 69.866 690.247 69.866 690.659 c f BT 75.016 686.995 Td /F1 9.0 Tf [(Any corrective or non-routine maintenance that can possibly be understood as a change to a piece of validated )] TJ ET BT 75.016 673.259 Td /F1 9.0 Tf [(equipment, especially parts changes, must be processed through change control before being performed.)] TJ ET 69.866 663.187 m 69.866 663.599 69.696 664.009 69.404 664.300 c 69.113 664.592 68.703 664.762 68.291 664.762 c 67.878 664.762 67.469 664.592 67.177 664.300 c 66.885 664.009 66.716 663.599 66.716 663.187 c 66.716 662.774 66.885 662.365 67.177 662.073 c 67.469 661.781 67.878 661.612 68.291 661.612 c 68.703 661.612 69.113 661.781 69.404 662.073 c 69.696 662.365 69.866 662.774 69.866 663.187 c f BT 75.016 659.523 Td /F1 9.0 Tf [(Maintenance records should be reviewed regularly to identify any trends.)] TJ ET 69.866 649.451 m 69.866 649.863 69.696 650.273 69.404 650.564 c 69.113 650.856 68.703 651.026 68.291 651.026 c 67.878 651.026 67.469 650.856 67.177 650.564 c 66.885 650.273 66.716 649.863 66.716 649.451 c 66.716 649.038 66.885 648.628 67.177 648.337 c 67.469 648.045 67.878 647.876 68.291 647.876 c 68.703 647.876 69.113 648.045 69.404 648.337 c 69.696 648.628 69.866 649.038 69.866 649.451 c f BT 75.016 645.787 Td /F1 9.0 Tf [(Records of non-completed and/or late preventive maintenance must be generated and reviewed by appropriate )] TJ ET BT 75.016 632.050 Td /F1 9.0 Tf [(management personnel. Corrective action plans should be developed.)] TJ ET 69.866 621.978 m 69.866 622.390 69.696 622.800 69.404 623.092 c 69.113 623.383 68.703 623.553 68.291 623.553 c 67.878 623.553 67.469 623.383 67.177 623.092 c 66.885 622.800 66.716 622.390 66.716 621.978 c 66.716 621.566 66.885 621.156 67.177 620.864 c 67.469 620.573 67.878 620.403 68.291 620.403 c 68.703 620.403 69.113 620.573 69.404 620.864 c 69.696 621.156 69.866 621.566 69.866 621.978 c f BT 75.016 618.314 Td /F1 9.0 Tf [(Spare parts and consumables should be maintained and controlled to ensure correct replacement parts and )] TJ ET BT 75.016 604.578 Td /F1 9.0 Tf [(consumables are used.)] TJ ET 69.866 594.506 m 69.866 594.918 69.696 595.328 69.404 595.619 c 69.113 595.911 68.703 596.081 68.291 596.081 c 67.878 596.081 67.469 595.911 67.177 595.619 c 66.885 595.328 66.716 594.918 66.716 594.506 c 66.716 594.093 66.885 593.683 67.177 593.392 c 67.469 593.100 67.878 592.931 68.291 592.931 c 68.703 592.931 69.113 593.100 69.404 593.392 c 69.696 593.683 69.866 594.093 69.866 594.506 c f BT 75.016 590.842 Td /F1 9.0 Tf [(Functionally equivalent parts should be subject to review and approval prior to use in validated equipment. Note: Like-)] TJ ET BT 75.016 577.105 Td /F1 9.0 Tf [(for-like terminology may have different meanings in different organizations. Some identify like-for-like as an exact )] TJ ET BT 75.016 563.369 Td /F1 9.0 Tf [(replacement part \(i.e., same manufacturer, model number, etc.\) as originally provided. Other organizations define like-)] TJ ET BT 75.016 549.633 Td /F1 9.0 Tf [(for-like as a replacement part that has the same characteristics. In one organization, the central corporate )] TJ ET BT 75.016 535.897 Td /F1 9.0 Tf [(organization used the term as exact replacement, but the sites used the term to mean an equivalent part. )] TJ ET BT 75.016 522.160 Td /F1 9.0 Tf [(Organizations must clearly define like-for-like to be sure that all areas follow the same interpretation. Alternatively, a )] TJ ET BT 75.016 508.424 Td /F1 9.0 Tf [(more descriptive term such as functionally equivalent may be used in place of like-for like.)] TJ ET 69.866 498.352 m 69.866 498.764 69.696 499.174 69.404 499.465 c 69.113 499.757 68.703 499.927 68.291 499.927 c 67.878 499.927 67.469 499.757 67.177 499.465 c 66.885 499.174 66.716 498.764 66.716 498.352 c 66.716 497.939 66.885 497.530 67.177 497.238 c 67.469 496.946 67.878 496.777 68.291 496.777 c 68.703 496.777 69.113 496.946 69.404 497.238 c 69.696 497.530 69.866 497.939 69.866 498.352 c f BT 75.016 494.688 Td /F1 9.0 Tf [(There must be certainty that like-for-like /functionally equivalent equipment is correctly installed.)] TJ ET 69.866 484.616 m 69.866 485.028 69.696 485.438 69.404 485.729 c 69.113 486.021 68.703 486.191 68.291 486.191 c 67.878 486.191 67.469 486.021 67.177 485.729 c 66.885 485.438 66.716 485.028 66.716 484.616 c 66.716 484.203 66.885 483.793 67.177 483.502 c 67.469 483.210 67.878 483.041 68.291 483.041 c 68.703 483.041 69.113 483.210 69.404 483.502 c 69.696 483.793 69.866 484.203 69.866 484.616 c f BT 75.016 480.952 Td /F1 9.0 Tf [(The maintenance department may be responsible for generation and maintenance of logbooks for facility and utility )] TJ ET BT 75.016 467.215 Td /F1 9.0 Tf [(equipment.)] TJ ET 69.866 457.143 m 69.866 457.555 69.696 457.965 69.404 458.257 c 69.113 458.548 68.703 458.718 68.291 458.718 c 67.878 458.718 67.469 458.548 67.177 458.257 c 66.885 457.965 66.716 457.555 66.716 457.143 c 66.716 456.731 66.885 456.321 67.177 456.029 c 67.469 455.738 67.878 455.568 68.291 455.568 c 68.703 455.568 69.113 455.738 69.404 456.029 c 69.696 456.321 69.866 456.731 69.866 457.143 c f BT 75.016 453.479 Td /F1 9.0 Tf [(Any maintenance personnel working on equipment should be complete equipment logbooks in clear, understandable )] TJ ET BT 75.016 439.743 Td /F1 9.0 Tf [(terms.)] TJ ET BT 45.016 417.007 Td /F4 9.0 Tf [(RECORD KEEPING)] TJ ET 69.866 397.934 m 69.866 398.347 69.696 398.756 69.404 399.048 c 69.113 399.340 68.703 399.509 68.291 399.509 c 67.878 399.509 67.469 399.340 67.177 399.048 c 66.885 398.756 66.716 398.347 66.716 397.934 c 66.716 397.522 66.885 397.112 67.177 396.821 c 67.469 396.529 67.878 396.359 68.291 396.359 c 68.703 396.359 69.113 396.529 69.404 396.821 c 69.696 397.112 69.866 397.522 69.866 397.934 c f BT 75.016 394.270 Td /F1 9.0 Tf [(The person fulfilling the work order shall complete preventive, corrective, and changed maintenance records/work )] TJ ET BT 75.016 380.534 Td /F1 9.0 Tf [(orders.)] TJ ET 69.866 370.462 m 69.866 370.874 69.696 371.284 69.404 371.575 c 69.113 371.867 68.703 372.037 68.291 372.037 c 67.878 372.037 67.469 371.867 67.177 371.575 c 66.885 371.284 66.716 370.874 66.716 370.462 c 66.716 370.049 66.885 369.640 67.177 369.348 c 67.469 369.056 67.878 368.887 68.291 368.887 c 68.703 368.887 69.113 369.056 69.404 369.348 c 69.696 369.640 69.866 370.049 69.866 370.462 c f BT 75.016 366.798 Td /F1 9.0 Tf [(Records of all maintenance shall be maintained for a specified period beyond the longest expiration date of any )] TJ ET BT 75.016 353.062 Td /F1 9.0 Tf [(product the equipment produces.)] TJ ET 69.866 342.989 m 69.866 343.402 69.696 343.811 69.404 344.103 c 69.113 344.395 68.703 344.564 68.291 344.564 c 67.878 344.564 67.469 344.395 67.177 344.103 c 66.885 343.811 66.716 343.402 66.716 342.989 c 66.716 342.577 66.885 342.167 67.177 341.876 c 67.469 341.584 67.878 341.414 68.291 341.414 c 68.703 341.414 69.113 341.584 69.404 341.876 c 69.696 342.167 69.866 342.577 69.866 342.989 c f BT 75.016 339.325 Td /F1 9.0 Tf [(A chronological equipment history file for each instrument shall be established. To maintain and repair equipment )] TJ ET BT 75.016 325.589 Td /F1 9.0 Tf [(\(manufacturers manuals, drawings, etc.\) information must be kept in an equipment information file accessible to )] TJ ET BT 75.016 311.853 Td /F1 9.0 Tf [(technicians who need such information.)] TJ ET 69.866 301.781 m 69.866 302.193 69.696 302.603 69.404 302.894 c 69.113 303.186 68.703 303.356 68.291 303.356 c 67.878 303.356 67.469 303.186 67.177 302.894 c 66.885 302.603 66.716 302.193 66.716 301.781 c 66.716 301.368 66.885 300.958 67.177 300.667 c 67.469 300.375 67.878 300.206 68.291 300.206 c 68.703 300.206 69.113 300.375 69.404 300.667 c 69.696 300.958 69.866 301.368 69.866 301.781 c f BT 75.016 298.117 Td /F1 9.0 Tf [(Notations in equipment logbooks by any maintenance personnel shall be completed in clear, understandable terms.)] TJ ET BT 45.016 275.380 Td /F4 9.0 Tf [(PERSONNEL QUALIFICATIONS)] TJ ET 69.866 256.308 m 69.866 256.720 69.696 257.130 69.404 257.422 c 69.113 257.713 68.703 257.883 68.291 257.883 c 67.878 257.883 67.469 257.713 67.177 257.422 c 66.885 257.130 66.716 256.720 66.716 256.308 c 66.716 255.896 66.885 255.486 67.177 255.194 c 67.469 254.903 67.878 254.733 68.291 254.733 c 68.703 254.733 69.113 254.903 69.404 255.194 c 69.696 255.486 69.866 255.896 69.866 256.308 c f BT 75.016 252.644 Td /F1 9.0 Tf [(There must be a system for ensuring the qualification and technical training of technicians and mechanics employed in )] TJ ET BT 75.016 238.908 Td /F1 9.0 Tf [(the maintenance and repair of GMP equipment. This must include technical training on the specific requirements of )] TJ ET BT 75.016 225.172 Td /F1 9.0 Tf [(preventive maintenance procedures. Training must include in-house personnel as well as outside contracted staff.)] TJ ET 69.866 215.099 m 69.866 215.512 69.696 215.921 69.404 216.213 c 69.113 216.505 68.703 216.674 68.291 216.674 c 67.878 216.674 67.469 216.505 67.177 216.213 c 66.885 215.921 66.716 215.512 66.716 215.099 c 66.716 214.687 66.885 214.277 67.177 213.986 c 67.469 213.694 67.878 213.524 68.291 213.524 c 68.703 213.524 69.113 213.694 69.404 213.986 c 69.696 214.277 69.866 214.687 69.866 215.099 c f BT 75.016 211.435 Td /F1 9.0 Tf [(There must be a written procedure for the qualification and training of contracted mechanics and technicians used to )] TJ ET BT 75.016 197.699 Td /F1 9.0 Tf [(supplement facility resources.)] TJ ET 69.866 187.627 m 69.866 188.039 69.696 188.449 69.404 188.740 c 69.113 189.032 68.703 189.202 68.291 189.202 c 67.878 189.202 67.469 189.032 67.177 188.740 c 66.885 188.449 66.716 188.039 66.716 187.627 c 66.716 187.214 66.885 186.805 67.177 186.513 c 67.469 186.221 67.878 186.052 68.291 186.052 c 68.703 186.052 69.113 186.221 69.404 186.513 c 69.696 186.805 69.866 187.214 69.866 187.627 c f BT 75.016 183.963 Td /F1 9.0 Tf [(There must be regular training sessions for all maintenance personnel covering both cGMPs and job-specific issues.)] TJ ET BT 45.016 161.227 Td /F4 9.0 Tf [(FINAL THOUGHTS)] TJ ET BT 45.016 147.490 Td /F1 9.0 Tf [()] TJ ET BT 45.016 133.754 Td /F1 9.0 Tf [(The above considerations are offered as a basis for a compliant maintenance program. They do not cover all the aspects of a )] TJ ET BT 45.016 120.018 Td /F1 9.0 Tf [(preventative maintenance program. For example, considerations of how to qualify a maintenance contractor, reporting out-of-)] TJ ET BT 45.016 106.282 Td /F1 9.0 Tf [(frequency events for preventive maintenance, review of open corrective or non-routine work orders, a system for )] TJ ET BT 45.016 92.545 Td /F1 9.0 Tf [(reviewing/approving functionally equivalent parts, and other details must also be considered in a comprehensive program. )] TJ ET BT 45.016 78.809 Td /F1 9.0 Tf [(Developing a maintenance program is a significant undertaking. The fundamentals of a site maintenance program are best )] TJ ET BT 45.016 65.073 Td /F1 9.0 Tf [(done as completely as possible in the early stages of a facility lifecycle.)] TJ ET endstream endobj 27 0 obj << /Type /Page /Parent 3 0 R /Annots [ 29 0 R ] /Contents 28 0 R >> endobj 28 0 obj << /Length 827 >> stream 0.000 0.000 0.000 rg 0.000 0.000 0.000 RG 1.5 w 0 J [ ] 0 d 1.000 1.000 1.000 rg 34.016 34.016 527.249 773.859 re f 0.000 0.000 0.000 rg BT 45.016 796.885 Td /F1 9.0 Tf [()] TJ ET BT 45.016 783.149 Td /F4 9.0 Tf [(REFERENCES)] TJ ET BT 62.360 761.952 Td /F1 9.0 Tf [(1.)] TJ ET BT 75.016 760.413 Td /F1 9.0 Tf [(FDA, 21CFR211.67, Code of Federal Regulations Title 21, Volume 4, FDA, 2011. )] TJ ET BT 407.656 760.413 Td /F4 9.0 Tf [(JVT)] TJ ET q 45.016 737.416 506.159 0.000 re W n Q 0.620 0.620 0.620 rg 45.016 696.166 506.159 0.750 re f 0.000 0.000 0.000 rg BT 45.016 678.640 Td /F4 10.7 Tf [(Source URL:)] TJ ET BT 112.587 678.640 Td /F1 10.7 Tf [(http://www.ivtnetwork.com/article/cgmp-maintenance-program-considerations)] TJ ET 0.000 0.000 0.000 RG 0.21336 w 0 J [ ] 0 d 112.587 677.275 m 477.176 677.275 l S endstream endobj 29 0 obj << /Type /Annot /Subtype /Link /A 30 0 R /Border [0 0 0] /H /I /Rect [ 112.5869 677.6531 477.1764 688.5078 ] >> endobj 30 0 obj << /Type /Action /S /URI /URI (http://www.ivtnetwork.com/article/cgmp-maintenance-program-considerations) >> endobj 31 0 obj << /Names [(EmbeddedJS) 32 0 R] >> endobj 32 0 obj << /S /JavaScript /JS (\r addthis.button\('.add-this-button'\);\r ) >> endobj xref 0 33 0000000000 65535 f 0000000008 00000 n 0000000103 00000 n 0000000149 00000 n 0000000427 00000 n 0000000464 00000 n 0000000806 00000 n 0000000902 00000 n 0000005558 00000 n 0000005665 00000 n 0000005780 00000 n 0000005890 00000 n 0000006003 00000 n 0000006112 00000 n 0000010561 00000 n 0000017402 00000 n 0000017530 00000 n 0000017607 00000 n 0000017733 00000 n 0000017833 00000 n 0000017960 00000 n 0000018060 00000 n 0000018501 00000 n 0000056922 00000 n 0000056987 00000 n 0000065084 00000 n 0000065149 00000 n 0000079410 00000 n 0000079494 00000 n 0000080373 00000 n 0000080501 00000 n 0000080626 00000 n 0000080678 00000 n trailer << /Size 33 /Root 1 0 R /Info 5 0 R >> startxref 80774 %%EOF