{"id":4937,"date":"2026-10-08T15:03:10","date_gmt":"2026-10-08T15:03:10","guid":{"rendered":"https:\/\/28.feihuaweiye.com\/whats-documentation-and-qualification-of-pharma-bottle-liquid-filling-and-packing-machines\/"},"modified":"2026-11-07T06:51:34","modified_gmt":"2026-11-07T06:51:34","slug":"whats-documentation-and-qualification-of-pharma-bottle-liquid-filling-and-packing-machines","status":"publish","type":"post","link":"https:\/\/28.feihuaweiye.com\/ar\/whats-documentation-and-qualification-of-pharma-bottle-liquid-filling-and-packing-machines\/","title":{"rendered":"What&#8217;s Documentation and Qualification of Pharma Bottle Liquid Filling and Packing Machines ?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4937\" class=\"elementor elementor-4937\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-51e7efc e-con-boxed 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data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9b4533b elementor-widget elementor-widget-heading\" data-id=\"9b4533b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">What&#8217;s Documentation and Qualification of Pharma Bottle Liquid Filling and Packing Machines ?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-323076a elementor-invisible elementor-widget elementor-widget-image\" data-id=\"323076a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"850\" height=\"500\" src=\"https:\/\/28.feihuaweiye.com\/wp-content\/uploads\/2026\/10\/sterile-glass-ampoules-washing-machine-2.png\" class=\"attachment-full size-full wp-image-4869\" alt=\"\" srcset=\"https:\/\/28.feihuaweiye.com\/wp-content\/uploads\/2026\/10\/sterile-glass-ampoules-washing-machine-2.png 850w, https:\/\/28.feihuaweiye.com\/wp-content\/uploads\/2026\/10\/sterile-glass-ampoules-washing-machine-2-300x176.png 300w, https:\/\/28.feihuaweiye.com\/wp-content\/uploads\/2026\/10\/sterile-glass-ampoules-washing-machine-2-768x452.png 768w, https:\/\/28.feihuaweiye.com\/wp-content\/uploads\/2026\/10\/sterile-glass-ampoules-washing-machine-2-18x12.png 18w\" sizes=\"(max-width: 850px) 100vw, 850px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-508741d elementor-widget elementor-widget-post-info\" data-id=\"508741d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item- elementor-inline-item\" itemprop=\"author\">\n\t\t\t\t\t\t<a href=\"https:\/\/28.feihuaweiye.com\/ar\/author\/admin\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-user-circle\" viewBox=\"0 0 496 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M248 104c-53 0-96 43-96 96s43 96 96 96 96-43 96-96-43-96-96-96zm0 144c-26.5 0-48-21.5-48-48s21.5-48 48-48 48 21.5 48 48-21.5 48-48 48zm0-240C111 8 0 119 0 256s111 248 248 248 248-111 248-248S385 8 248 8zm0 448c-49.7 0-95.1-18.3-130.1-48.4 14.9-23 40.4-38.6 69.6-39.5 20.8 6.4 40.6 9.6 60.5 9.6s39.7-3.1 60.5-9.6c29.2 1 54.7 16.5 69.6 39.5-35 30.1-80.4 48.4-130.1 48.4zm162.7-84.1c-24.4-31.4-62.1-51.9-105.1-51.9-10.2 0-26 9.6-57.6 9.6-31.5 0-47.4-9.6-57.6-9.6-42.9 0-80.6 20.5-105.1 51.9C61.9 339.2 48 299.2 48 256c0-110.3 89.7-200 200-200s200 89.7 200 200c0 43.2-13.9 83.2-37.3 115.9z\"><\/path><\/svg>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-author\">\n\t\t\t\t\t\t\t\t\t\tadmin\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item- elementor-inline-item elementor-icon-list-item elementor-repeater-item- elementor-inline-item\" itemprop=\"author datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/28.feihuaweiye.com\/ar\/author\/admin\/ https:\/\/28.feihuaweiye.com\/ar\/2026\/10\/08\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-calendar\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M12 192h424c6.6 0 12 5.4 12 12v260c0 26.5-21.5 48-48 48H48c-26.5 0-48-21.5-48-48V204c0-6.6 5.4-12 12-12zm436-44v-36c0-26.5-21.5-48-48-48h-48V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H160V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H48C21.5 64 0 85.5 0 112v36c0 6.6 5.4 12 12 12h424c6.6 0 12-5.4 12-12z\"><\/path><\/svg>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-author elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\t<time>October 8, 2026<\/time>\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item- elementor-inline-item elementor-icon-list-item elementor-repeater-item- elementor-inline-item elementor-icon-list-item elementor-repeater-item- elementor-inline-item\" itemprop=\"author datePublished\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<svg 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elementor-icon-list-item elementor-repeater-item- elementor-inline-item elementor-icon-list-item elementor-repeater-item- elementor-inline-item elementor-icon-list-item elementor-repeater-item- elementor-inline-item\" itemprop=\"author datePublished commentCount\">\n\t\t\t\t\t\t<a href=\"https:\/\/28.feihuaweiye.com\/ar\/author\/admin\/ https:\/\/28.feihuaweiye.com\/ar\/2026\/10\/08\/ https:\/\/28.feihuaweiye.com\/ar\/whats-documentation-and-qualification-of-pharma-bottle-liquid-filling-and-packing-machines\/#respond\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-comment-dots\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M144 208c-17.7 0-32 14.3-32 32s14.3 32 32 32 32-14.3 32-32-14.3-32-32-32zm112 0c-17.7 0-32 14.3-32 32s14.3 32 32 32 32-14.3 32-32-14.3-32-32-32zm112 0c-17.7 0-32 14.3-32 32s14.3 32 32 32 32-14.3 32-32-14.3-32-32-32zM256 32C114.6 32 0 125.1 0 240c0 47.6 19.9 91.2 52.9 126.3C38 405.7 7 439.1 6.5 439.5c-6.6 7-8.4 17.2-4.6 26S14.4 480 24 480c61.5 0 110-25.7 139.1-46.3C192 442.8 223.2 448 256 448c141.4 0 256-93.1 256-208S397.4 32 256 32zm0 368c-26.7 0-53.1-4.1-78.4-12.1l-22.7-7.2-19.5 13.8c-14.3 10.1-33.9 21.4-57.5 29 7.3-12.1 14.4-25.7 19.9-40.2l10.6-28.1-20.6-21.8C69.7 314.1 48 282.2 48 240c0-88.2 93.3-160 208-160s208 71.8 208 160-93.3 160-208 160z\"><\/path><\/svg>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-author elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-time elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-comments\">\n\t\t\t\t\t\t\t\t\t\tNo Comments\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7ab156d elementor-widget elementor-widget-text-editor\" data-id=\"7ab156d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n<p>The qualification documentation can be adapted to the specific needs of the client offering an individual approach.<\/p>\n<h4><strong>DESIGN PROTOCOLS<\/strong><\/h4>\n<p>\u2014 Qualification Project Plan (QPP)<\/p>\n<p>\u2014 Functional and Design Specifications (FDS)<\/p>\n<p>\u2014 Hardware Design Specifications (HDS)<\/p>\n<p>\u2014 Software Design Specifications (SDS)<\/p>\n<p>\u2014 Risk Analysis (RA)<\/p>\n<h4><strong>TEST PROTOCOLS <\/strong><\/h4>\n<p>\u2014 Design Qualification (DQ)<\/p>\n<p>\u2014 Computer System Validation (CSV)<\/p>\n<p>\u2014 Factory Acceptance Test (FAT)<\/p>\n<p>\u2014 Installation and Commissioning (IAC)<\/p>\n<p>\u2014 Site Acceptance Test (SAT)<\/p>\n<p>\u2014 Installation Qualification (IQ)<\/p>\n<p>\u2014 Operational Qualification (OQ)<\/p>\n<p>\u2014 Record of qualification deviations<\/p>\n<p>\u2014 Record of qualification change controls<\/p>\n<p>\u00a0<\/p>\n<h4><strong>Documentation and Qualification of Pharma Filling and Packing Machines<\/strong><\/h4>\n<p>The pharmaceutical industry is one of the most highly regulated industries in the world. Every pharma filling and packing machine must be supported by complete documentation and a structured qualification process to demonstrate compliance with GMP FDA 21 CFR Part 11 and EU GMP Annex 1 requirements. Proper documentation not only ensures regulatory compliance but also helps pharmaceutical manufacturers achieve consistent product quality, traceability, and successful audits.<\/p>\n<p>This article explains the essential documentation package and qualification procedures for pharmaceutical liquid filling and packaging equipment.<\/p>\n<p>\u00a0<\/p>\n<h4><strong>\u00a0Why Documentation and Qualification Are Important<\/strong><\/h4>\n<p>Documentation and qualification verify that a machine:<\/p>\n<ul>\n<li>Performs as designed<\/li>\n<li>Meets User Requirement Specifications (URS)<\/li>\n<li>Produces consistent product quality<\/li>\n<li>Complies with GMP regulations<\/li>\n<li>Can be maintained and calibrated correctly<\/li>\n<li>Supports validation throughout its lifecycle<\/li>\n<\/ul>\n<p>Without proper qualification documentation, pharmaceutical manufacturers may fail GMP inspections or delay production approval.<\/p>\n<p>\u00a0<\/p>\n<h4><strong>Documentation Package for Pharma Filling Machines<\/strong><\/h4>\n<p>A professional pharmaceutical equipment supplier should provide a comprehensive documentation package.<\/p>\n<ol>\n<li>User Requirement Specification (URS)The URS defines the customer\u2019s expectations, including:<\/li>\n<\/ol>\n<p>\u00a0<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"34\">1<\/td>\n<td width=\"391\">Product type<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">2<\/td>\n<td width=\"391\">Bottle or vial specifications<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">3<\/td>\n<td width=\"391\">Filling accuracy<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">4<\/td>\n<td width=\"391\">Production capacity<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">5<\/td>\n<td width=\"391\">Regulatory requirements<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">6<\/td>\n<td width=\"391\">Cleaning requirements<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">7<\/td>\n<td width=\"391\">Automation level<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">8<\/td>\n<td width=\"391\">Data integrity requirements<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u00a0<\/p>\n<h4><strong>The URS serves as the foundation for equipment design and qualification.<\/strong><\/h4>\n<p>2. Functional Design Specification (FDS)The FDS explains how the machine fulfills the URS.Typical contents include:<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"34\">1<\/td>\n<td width=\"391\">Machine operating sequence<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">2<\/td>\n<td width=\"391\">Software logic<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">3<\/td>\n<td width=\"391\">Servo control strategy<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">4<\/td>\n<td width=\"391\">Alarm management<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">5<\/td>\n<td width=\"391\">Interlock logic<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">6<\/td>\n<td width=\"391\">User interface design<\/td>\n<\/tr>\n<tr>\n<td width=\"34\">7<\/td>\n<td width=\"391\">Recipe management<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u00a0<\/p>\n<p>3. Hardware Design Specification (HDS)<\/p>\n<p>The HDS describes all hardware components, including: PLC, HMI, Servo motors, Sensors, Pumps, Pneumatic components, Electrical panels, Wiring diagrams<\/p>\n<p>4. Mechanical DrawingsTypical drawings include:<\/p>\n<p>General Arrangement (GA), P&amp;ID, Mechanical assembly drawings, Spare parts drawings, Format change parts, Utility connection drawings<\/p>\n<p>5. Electrical Documentation, Electrical documents usually include: Electrical schematic, PLC I\/O list, layout, Cable list, Electrical cabinet layout, Safety circuit diagram<\/p>\n<p>6. Software Documentation, For automated filling systems:<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"41\">1<\/td>\n<td width=\"153\">PLC program backup<\/td>\n<td width=\"231\">\u221a<\/td>\n<\/tr>\n<tr>\n<td width=\"41\">2<\/td>\n<td width=\"153\">HMI project backup<\/td>\n<td width=\"231\">\u221a<\/td>\n<\/tr>\n<tr>\n<td width=\"41\">3<\/td>\n<td width=\"153\">Software version records<\/td>\n<td width=\"231\">\u221a<\/td>\n<\/tr>\n<tr>\n<td width=\"41\">4<\/td>\n<td width=\"153\">Password management<\/td>\n<td width=\"231\">\u221a<\/td>\n<\/tr>\n<tr>\n<td width=\"41\">5<\/td>\n<td width=\"153\">Audit Trail configuration<\/td>\n<td width=\"231\">\u221a<\/td>\n<\/tr>\n<tr>\n<td width=\"41\">6<\/td>\n<td width=\"153\">User access levels<\/td>\n<td width=\"231\">\u221a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u00a0<\/p>\n<p>7. Operating Manual, The operation manual should cover:<\/p>\n<ul>\n<li>Machine startup<\/li>\n<li>Product changeover<\/li>\n<li>Alarm troubleshooting<\/li>\n<li>Cleaning procedures<\/li>\n<li>Maintenance schedule<\/li>\n<li>Safety precautions<\/li>\n<\/ul>\n<p>8. Maintenance Manual, Maintenance documentation includes:<\/p>\n<ul>\n<li>Lubrication schedule<\/li>\n<li>Wear parts replacement<\/li>\n<li>Preventive maintenance checklist<\/li>\n<li>Recommended spare parts<\/li>\n<li>Calibration procedures<\/li>\n<\/ul>\n<p>9. Material Certificates, Critical product-contact components should include:<\/p>\n<ul>\n<li>Stainless steel certificates (typically SS316L)<\/li>\n<li>Surface finish certificates<\/li>\n<li>Elastomer certifications<\/li>\n<li>FDA-compliant material declarations<\/li>\n<\/ul>\n<p>10. Calibration Certificates, Typical calibration documents include:<\/p>\n<ul>\n<li>Pressure gauges<\/li>\n<li>Temperature sensors<\/li>\n<li>Load cells<\/li>\n<li>Flow meters<\/li>\n<li>Weighing systems<\/li>\n<li>Torque testers<\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<h4>Qualification Process, Equipment qualification follows a lifecycle approach recommended by GMP and ISPE.<\/h4>\n<p>1. Design Qualification (DQ)<\/p>\n<p>DQ verifies that the equipment design meets the URS and applicable GMP requirements before manufacturing begins., Typical DQ activities:<\/p>\n<ul>\n<li>Design review<\/li>\n<li>Risk assessment<\/li>\n<li>Component selection<\/li>\n<li>Hygienic design evaluation<\/li>\n<li>Compliance review<\/li>\n<\/ul>\n<p>2. Factory Acceptance Test (FAT)<\/p>\n<p>FAT is performed at the equipment manufacturer\u2019s facility before shipment.\u00a0Typical FAT tests include:<\/p>\n<p>\u00a0<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"142\">Mechanical inspection<\/td>\n<td width=\"142\">Alarm verification<\/td>\n<td width=\"142\">Documentation review<\/td>\n<\/tr>\n<tr>\n<td width=\"142\">Filling accuracy test<\/td>\n<td width=\"142\">Recipe testing<\/td>\n<td width=\"142\">Changeover demonstration<\/td>\n<\/tr>\n<tr>\n<td width=\"142\">Speed verification<\/td>\n<td width=\"142\">Safety interlock testing<\/td>\n<td width=\"142\">Sensor testing<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u00a0<\/p>\n<p>3. Site Acceptance Test (SAT), SAT confirms that the equipment operates correctly after installation.Typical SAT includes:<\/p>\n<ul>\n<li>Utility verification<\/li>\n<li>Installation inspection<\/li>\n<li>Machine leveling<\/li>\n<li>Functional testing<\/li>\n<li>Product trial<\/li>\n<li>Operator training<\/li>\n<\/ul>\n<p>4. Installation Qualification (IQ)<\/p>\n<p>IQ documents that the equipment has been installed according to approved specifications.\u00a0Typical IQ items include:<\/p>\n<ul>\n<li>Equipment identification<\/li>\n<li>Utility connections<\/li>\n<li>Component verification<\/li>\n<li>Instrument calibration<\/li>\n<li>Material verification<\/li>\n<li>Drawing verification<\/li>\n<\/ul>\n<p>5. Operational Qualification (OQ)<\/p>\n<p>OQ demonstrates that the equipment operates correctly throughout its intended operating range.\u00a0Typical OQ tests:<\/p>\n<ul>\n<li>Filling accuracy<\/li>\n<li>Filling repeatability<\/li>\n<li>Speed testing<\/li>\n<li>Alarm verification<\/li>\n<li>Sensor challenge tests<\/li>\n<li>No bottle no fill<\/li>\n<li>No cap no capping<\/li>\n<li>Rejection system verification<\/li>\n<li>Emergency stop testing<\/li>\n<\/ul>\n<p>6. Performance Qualification (PQ)<\/p>\n<p>PQ verifies that the machine consistently produces acceptable products under actual production conditions.\u00a0Typical PQ includes:<\/p>\n<ul>\n<li>Three consecutive successful production batches<\/li>\n<li>Statistical filling accuracy analysis<\/li>\n<li>Process capability evaluation<\/li>\n<li>Visual inspection results<\/li>\n<li>Reject rate analysis<\/li>\n<\/ul>\n<p>Validation Documents Commonly Included\u00a0, A complete validation package may include:<\/p>\n<p>\u00a0<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"42\">No.<\/td>\n<td width=\"176\">Document<\/td>\n<td width=\"215\">Purpose<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">1<\/td>\n<td width=\"176\">URS<\/td>\n<td width=\"215\">User requirements<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">2<\/td>\n<td width=\"176\">Risk Assessment<\/td>\n<td width=\"215\">Identify potential risks<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">3<\/td>\n<td width=\"176\">DQ Protocol &amp; Report<\/td>\n<td width=\"215\">Design verification<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">4<\/td>\n<td width=\"176\">FAT Protocol &amp; Report<\/td>\n<td width=\"215\">Factory testing<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">5<\/td>\n<td width=\"176\">SAT Protocol &amp; Report<\/td>\n<td width=\"215\">Site testing<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">6<\/td>\n<td width=\"176\">IQ Protocol &amp; Report<\/td>\n<td width=\"215\">Installation verification<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">7<\/td>\n<td width=\"176\">OQ Protocol &amp; Report<\/td>\n<td width=\"215\">Operational verification<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">8<\/td>\n<td width=\"176\">PQ Protocol &amp; Report<\/td>\n<td width=\"215\">Production verification<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">9<\/td>\n<td width=\"176\">Calibration Records<\/td>\n<td width=\"215\">Instrument accuracy<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">10<\/td>\n<td width=\"176\">SOP<\/td>\n<td width=\"215\">Standard operating procedures<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">11<\/td>\n<td width=\"176\">Preventive Maintenance Plan<\/td>\n<td width=\"215\">Equipment maintenance<\/td>\n<\/tr>\n<tr>\n<td width=\"42\">12<\/td>\n<td width=\"176\">\u00a0Spare Parts List<\/td>\n<td width=\"215\">Long-term support<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u00a0<\/p>\n<p>Compliance Standards, Well-designed pharmaceutical filling and packaging machines are typically manufactured to comply with:<\/p>\n<p>\u00a0<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"44\">1<\/td>\n<td width=\"381\">* GMP (Good Manufacturing Practice)<\/td>\n<\/tr>\n<tr>\n<td width=\"44\">2<\/td>\n<td width=\"381\">* EU GMP Annex 1<\/td>\n<\/tr>\n<tr>\n<td width=\"44\">3<\/td>\n<td width=\"381\">* FDA 21 CFR Parts 210 &amp; 211<\/td>\n<\/tr>\n<tr>\n<td width=\"44\">4<\/td>\n<td width=\"381\">* FDA 21 CFR Part 11 (for electronic records and audit trails)<\/td>\n<\/tr>\n<tr>\n<td width=\"44\">5<\/td>\n<td width=\"381\">* GAMP 5 guidance for computerized systems<\/td>\n<\/tr>\n<tr>\n<td width=\"44\">6<\/td>\n<td width=\"381\">* ISO 9001 Quality Management System<\/td>\n<\/tr>\n<tr>\n<td width=\"44\">7<\/td>\n<td width=\"381\">* CE Machinery Directive (where applicable)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u00a0<\/p>\n<p>Choosing a Supplier That Supports Qualification, When selecting a pharmaceutical filling machine supplier, consider whether they can provide:<\/p>\n<ul>\n<li>Complete GMP documentation<\/li>\n<li>FAT and SAT support<\/li>\n<li>IQ\/OQ protocol templates<\/li>\n<li>Validation assistance<\/li>\n<li>Audit Trail and electronic records<\/li>\n<li>Calibration certificates<\/li>\n<li>Long-term technical support<\/li>\n<li>Spare parts availability<\/li>\n<li>Remote troubleshooting services<\/li>\n<\/ul>\n<p>An experienced supplier can significantly reduce qualification time and accelerate project commissioning.<\/p>\n<!--[googlesitekit-end-of-content]-->\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cd27972 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                placeholder=\"\" \/>\n                                <\/div>\n\n                    <\/div>\n                <div class=\"cxb-form-field cxb-form-field--textarea\" style=\"--cxb-w:12;\">\n\n                                                            <label class=\"cxb-form-label\" for=\"cxbf_1a572bd_5\">\n                        Message                    <\/label>\n                            \n            <div class=\"cxb-form-control\">\n                                <textarea class=\"cxb-form-textarea\" id=\"cxbf_1a572bd_5\"\n                              name=\"cxbf_1a572bd_5\"\n                              rows=\"4\"\n                              placeholder=\"\"><\/textarea>\n                                <\/div>\n\n                    <\/div>\n                        <\/div>\n\n                \n                                                        <div class=\"cxb-form-hp\" aria-hidden=\"true\">\n                        <label for=\"cxb_hp_1a572bd\">Leave this field empty<\/label>\n                        <input type=\"text\" id=\"cxb_hp_1a572bd\" name=\"cxb_form_hp\"\n                               tabindex=\"-1\" autocomplete=\"off\" value=\"\" \/>\n                    <\/div>\n                    <input type=\"hidden\" name=\"cxb_form_hp_on\" value=\"1\" \/>\n                \n                                <input type=\"hidden\" name=\"cxb_form_rendered_at\" class=\"cxb-form-rendered-at\" value=\"\" \/>\n                <input type=\"hidden\" name=\"cxb_form_min_seconds\" value=\"3\" \/>\n\n                \n                \n                <div class=\"cxb-form-actions\">\n                    <button type=\"submit\" class=\"cxb-form-submit\">\n                        Submit Inquiry                    <\/button>\n                <\/div>\n\n                \n                                    <div class=\"cxb-form-message\" role=\"alert\" aria-live=\"polite\" style=\"display:none;\"><\/div>\n           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