GMP印字包装材料制版印刷管理规程

1．目的本文件规定了印刷包装材料的设计、审核、批准、备案和印刷管理要求，避免包装材料混淆、管理不严等差错的发生。

2．适用范围适用于公司药品使用的所有印刷包材、标签、说明书等。

3.责任本文件由供应部起草，注册专员、生产部、技术中心、质量管理部进行审核，质量授权人进行批准，技术中心、供应部、营销部、质量部负责具体的实施。

4．内容4.1.定义：印刷包装材料指具有特定式样和印刷内容，并经药品监督管理部门批准的包装材料，如印字铝箔、标签、说明书、纸盒等。

4.1.印刷包装材料的设计4.1.1.当现用印刷包装材料的文字、图案或颜色尺寸等需做更改时，或新产品需进行包装设计时，由营销部和质量部提出设计或更改要求，总经理批准后，由包装材料设计员开始设计或委托外单位设计。

4.1.2.印刷包装材料设计按照国家相关法规和对药品包材的管理要求的内容进行设计，并打印出设计纸样或模型。

4.1.3.产品装箱单和产品合格证的设计由生产部和质量部共同设计，并将打印稿交供应部印制。

4.2.印刷包装材料内容的审核、批准、备案4.2.1.包装材料设计专员将印刷包装材料（包装用纸箱、小盒、中盒（如有）、标签，印字铝箔、印字复合膜、说明书）的设计稿进行设计，然后打印出样稿，分别送营销部、生产部、技术中心负责人进行审核，并在样稿上签字确认，确认样稿的相关内容是否符合规定，样稿上要明确审核意见，并注明审核日期，然后把样稿送质量管理部进行审核，质量管理部由包材检验QC进行审核，注明审核意见并签名并注明审核日期后交药品注册专员和质量管理部长进行审核，签字，并注明审核日期，再退回到包装材料设计专员手中，包装材料设计专员根据审核意见对样稿进行修改，修改后的样稿（一式三份：一份用于备案，一份用于检验，一份用于存档保存）附初审样稿按以上顺序进行重新审核，审核合格后的终稿报总经理批准。

4.2.2.批准后的设计样稿,由注册专员报省食品药品监督管理局补充申请批准备案。

PURPOSEThe purpose of this Standard Operating Procedure (SOP) is to describe the steps involved for the creation, approval and printing of packaging components.SCOPEThis SOP applies to all personnel engaged in the creation, approval and printing of packaging components at CURE Pharmaceutical, Oxnard, CA. This SOP applies to printed components for third parties unless the third party has a company SOP in place that both parties agree to follow.RESPONSIBILITIESPackage Development:•Determine appropriate packaging components based upon business development and production needs.•Source packaging components.•Obtain die-lines from suppliers.•Perform audits of print suppliers as required.•Ensure part numbers are placed on all components as required.•Ensure changes are processed through the change control system.Business Development:•For items used in contract manufacturing for a customer, act as the liaison between the customer and CURE to determine customer needs in terms of graphic design, package size and functionality.•Provide supplement facts approved by R&D to customer for inclusion on packaging components.•Provide applicable CURE part numbers to the customer for inclusion on packaging components.•Provide manufacturing specs to customer for packaging including specs for label rolls, pouches, etc.where it may impact production (if customer is providing packaging).Creative Director:•Create die-lines and package component artwork as required.•Approve print proofs and press proofs as required.•Send approved artwork files to print suppliers.Research and Development:•Provide an approved list of active and inactive ingredients in a formulation.•Provide supplement facts in MMR to be used on printed packaging components.Customer:•Ensure the accuracy of all text on packaging components.•Ensure compliance with all regulatory requirements for the product.•Ensure text includes all applicable warnings and allergen listings.•Provide signed copies of artwork, print proofs and press proofs as requested by CURE.Quality Assurance:•Perform audits of print suppliers as required.•Sign off on artwork specs and print proofs as required.•Create Master Labels from approved packaging components.Production:•Ensure production concerns are met in terms of machinability.•Approve dyelines and carton blanks prior to printing.•Ensure lot and exp. area is identified on labels, cartons and other packaging as required and that enough space is available for printing of lot and exp.REFERENCESSOP 113 Receipt and Inspection of Printed Packaging ComponentsSOP 105 Change Control SystemSOP 117 Elements and Generation of Master Manufacturing RecordSOP 129 Document Numbering SystemDEFINITIONSArtwork Specification: Computer file of artwork containing dieline, graphics and all colors used that is sent to a printer.Dieline: The outline of a printed packaging component, usually provided by the printer. The dieline indicates die cuts, folds, and print constraints and is used by the graphic artist to enter text and graphics.Master Label: Signed copy of actual printed component kept on file at CURE and used as a reference to check subsequent lots of components.Packaging Component: Materials used to enclose and/or protect products for distribution, storage, sale and use. Press Proof: Actual component from a printing press that shows precisely what the printed piece will look like. Print Proof: PDF (or other) copy of the artwork created by a printer showing the file as it will be printed. Contains dieline, colors, perforations, folds, cutouts and varnish layers as appropriate.Printed Packaging Component: A packaging component printed with text and graphics used to identify and provide information about the product. Examples include primary package labels, inner cartons and outer packers, and any other printed card or insert enclosed in the package.PROCEDURE1. Determine size and style of component1.1 Once the need for a new or revised printed component is identified, Package Development willdetermine the appropriate size and style of the label, carton, packer, or other component.1.2 Assign a part number. Part numbers are obtained from QA. For a component that has major textrevisions, a unique suffix will be added to the part number to differentiate it on the MasterPackaging Configuration, BOMs, and in the warehouse.2. Verify size and style of component2.1 Dieline and Layout Format2.1.1 Ensure the item is a size that can be handled on the current labeling and packagingequipment or is a size and shape that can be handled easily if hand applied orassembled.2.1.2 Ensure the proper area has been identified for stamping or imprinting of the lot andexp. date on the component.2.1.3 Ensure the words Lot: and Best By: are preprinted if required. Verify that thecustomer has approved this wording.2.1.4 Ensure that a no-varnish area is provided if needed. Check with production.2.1.5 Ensure that the necessary perforations are in place to facilitate bending or tearing ofthe label or carton as needed. Check with print supplier that the perforation sizechosen will provide the desired opening or bending feature.2.1.6 Obtain a die-line from the printed component supplier, or approve a die-line createdby Creative Director.2.2 Customer approval of package style2.2.1 Business Development should obtain customer approval of the size and style of thepackage component before the text and graphics are created.2.2.2 Business Development should discuss with customer any possible cost implicationsof the package style chosen, either costs incurred directly from printer or costsincurred from hand packaging or modifications to packaging equipment.3. Create graphic layout and text layout.3.1 Graphic Design3.1.1 Graphic layout is determined by Business Development, Creative Director and thecustomer.3.1.2 Package Development will ensure that chosen graphic style can be printedsuccessfully.3.1.3 Business Development should discuss costs with customer for chosen designincluding number of colors, special cut-outs, embossing, and varnishing.3.2 Text3.2.1 Text should comply with all applicable guidelines for dietary supplements. Customeris responsible for ensuring compliance.3.2.2 At a minimum, the following items should appear on a sachet or immediate carton.Examples are given in right column. Labels will contain abbreviated informationdetermined by the size of the label.3.2.2.1 Product Name: Trade Name or Brand Name3.2.2.2 Description: Oral Thin Film, Oral Strips, Gel, etc.3.2.2.3 General Usage: Energy, Focus, etc.3.2.2.4 Flavor: Cherry, Spearmint, etc.3.2.2.5 Product Class: Dietary Supplement3.2.2.6 Quantity in Pkg: One Strip, 12 Strips3.2.2.7 Lot Number/Batch: (printed in production)3.2.2.8 Exp or Best By :(printed in production)3.2.2.9 Recommended Use (varies)3.2.2.10 Caution Statements: Do not take more than 3 Strips per day3.2.2.11 Warnings: (varies)3.2.2.12 Supplement Facts: * See Next Section3.2.2.13 Other Ingredients List inactive ingredients3.2.2.14 List of Allergens3.2.2.15 Distributor name and address3.2.2.16 Place of Manufacture (Made in USA)3.2.2.17 Package Component Part Number3.2.3 The following additional items may appear3.2.3.1 Marketing Info: Great Tasting, Long Lasting3.2.3.2 Package Instructions: Tear Here3.2.3.3 Bar Codes (varies)3.2.3.4 Website info: (varies)3.2.4 Supplement Facts*3.2.4.1 The Supplement Facts Label must appear on all sale packages, such assachets and inner cartons.3.2.4.2 The Supplement Facts are detailed in the Master Manufacturing Recordand must match.4. Approval of Artwork4.1. Once artwork is completed, artwork should be signed by the following groups, according to theitems listed in the responsibilities section:4.1.1. Customer4.1.2. Business Development4.1.3. Package Development5. Send Files to Printer5.1. Once artwork is approved, Customer or Package Development sends files to the appropriateprinter. Files are sent in the format requested by the printer.5.2 Package Development files one hard copy in the Packaging Specifications Book in QA and oneelectronic copy in a secure location in the CURE document control folder.6. Receive and Approve Print Proofs6.1. Printer will send Print Proofs via email or as hard copies to Package Development.6.2. Package Development and QA approve Print Proofs based upon signed artwork.6.3. Package Development sends print proofs to customer for approval6.4. Package Development sends one copy back to printer and files one copy in PackagingSpecifications Book in QA, and files the electronic copy, if available in a secure location in theCURE document control folder.6.5. This is the signal to the printer that items are ready for print and no other changes will be made.7. Approval of Press ProofsPress proofs are sometimes created prior to the complete print job being finalized. For digital labels, digital files are sent by hard copy for approval. For other items, the customer or CURE may sign off on a press proof at the printer’s location.7.1. For Digital Labels, printer will send a press proof for approval.7.2. Package Development and QA approve Press Proofs based upon Print Proof.7.3. Package Development sends one copy back to printer and files one copy in PackagingSpecifications Book in QA.7.4. Press Proofs that are signed off at the printer’s location are not taken back to CURE and are notarchived.8. After Press Proofs are approved, items are printed and shipped to CURE to await inspection.REVISION HISTORY。

GMP包装材料使用管理规程一、目的和适用范围1.1目的：为确保GMP制药企业包装过程的安全性、可靠性和符合法规要求，制定本规程。

1.2适用范围：适用于所有GMP制药企业的包装过程，包括原料包装材料和成品包装材料的选择、采购、使用、检验和存储等环节。

二、术语和定义2.1 GMP：良好的生产规范（Good Manufacturing Practice），是指在制药过程中，为确保产品质量、减少潜在风险，并符合相关法规要求而采取的一系列质量管理准则。

2.2包装材料：指用于药品包装的各种材料，包括但不限于塑料瓶、铝箔、玻璃瓶、纸盒等。

2.3原料包装材料：指用于包装药品原料的各种材料。

2.4成品包装材料：指用于包装药品成品的各种材料。

三、包装材料的选择和采购3.1包装材料的选择应符合相关法规要求，并根据产品的特性和包装要求进行综合考量。

3.2包装材料的采购应通过合法渠道进行，供应商应具备相应的资质和证明文件，且与制药企业签订采购合同。

四、包装材料的接收和使用4.1包装材料的接收应由专人进行，按照检验标准进行检验，确认合格后方可接收。

4.2包装材料的使用应按照产品包装工艺要求进行，确保材料的正确使用。

4.3包装材料的使用应保持清洁卫生，防止污染和交叉污染。

五、包装材料的检验和记录5.1包装材料的质量检验应依据相关法规和企业内部质量标准进行，包括外观检查、尺寸检测、物理性能测试等项目。

5.2包装材料的检验记录应详细、真实，并保存至少两年，用于追溯和质量溯源。

六、包装材料的存储和保管6.1包装材料的存储应符合相关法规要求，并根据材料的特性进行分类和区分储存。

6.2包装材料的保管应有专人负责，并按照合理的方法和条件进行储存，确保材料的完好性和使用性能。

6.3包装材料的存储记录应详细、真实，并保存至少两年，用于追溯和质量溯源。

七、包装材料的变更管理7.1包装材料的变更应经过审批程序，并按照相关法规的要求进行记录和报告。

GMP质量体系印刷包装材料接收贮存发放领用和销毁管理规程一、目的为了确保印刷包装材料接收、贮存、发放、领用和销毁的流程规范和质量安全，制定本管理规程。

二、适用范围本管理规程适用于质量体系内的印刷包装材料的接收、贮存、发放、领用和销毁的管理。

三、接收管理1.印刷包装材料的接收应由质量管理部门负责，并记录相关信息。

2.接收人员应按照标准操作程序进行接收，检查印刷包装材料的外观、尺寸、印刷质量等是否满足要求。

3.如发现印刷包装材料存在质量问题，应立即通知相关部门，包括供应商及时处理。

四、贮存管理1.印刷包装材料应存放在干燥、通风、无异味、无有害物质的库房内，避免与有毒有害物质接触。

2.库房应定期进行清理，保持环境整洁。

3.印刷包装材料应按照不同种类、规格和批次分类存放，并做好标识和记录。

五、发放和领用管理1.发放和领用印刷包装材料应有专人负责，并记录相关信息，包括领用人员、领用数量、领用日期等。

2.发放和领用的印刷包装材料应按照先进先出的原则进行，确保及时使用到期限较早的材料。

3.发放和领用的印刷包装材料应进行必要的验收，确认符合质量要求后方可使用。

六、销毁管理1.无法使用的印刷包装材料应进行及时销毁，防止误用。

2.销毁过程中应确保材料无法再被使用，并记录销毁的数量和日期。

3.销毁的印刷包装材料应按照环保标准进行处理，防止对环境造成污染。

七、不合格品处理1.如发现印刷包装材料不符合质量要求，应立即停止使用并通知相关部门进行处理。

2.不合格品应按照质量管理部门的要求进行分类、记录和处理，包括归库、返厂修复、退货等，并进行相关报告。

八、培训和记录1.对质量管理部门及相关人员应进行培训，使其了解本管理规程的要求和操作流程。

2.培训记录应保存至少两年，并定期进行复查。

3.所有相关操作人员应按照规定的程序进行记录，包括接收记录、发放记录、领用记录、销毁记录等。

九、审查与改进1.定期对印刷包装材料接收、贮存、发放、领用和销毁的管理进行内审，确保符合质量体系要求。